<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03034954</url>
  </required_header>
  <id_info>
    <org_study_id>HUM00111090.1 PCN</org_study_id>
    <nct_id>NCT03034954</nct_id>
  </id_info>
  <brief_title>Patient Centered-Rehabilitation ver111090.1</brief_title>
  <acronym>PCN1</acronym>
  <official_title>Effects of 3mA HD-tDCS on Associative and Working Memory in Cognitively Intact Older Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Michigan</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      As we age, a number of factors can reduce our cognitive (or thinking) abilities. This study&#xD;
      will evaluate whether transcranial electrical stimulation (TES), which uses small amounts of&#xD;
      electricity to modulate brain functioning, can improve cognitive abilities. Here, the effects&#xD;
      of TES on working memory, learning, and memory, will be evaluated in a group of healthy older&#xD;
      adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective is to investigate the cognitive effects of high definition anodal tDCS&#xD;
      (HD-tDCS; anode at center electrode) at 3 mA (for 20 minutes) on learning, memory, and&#xD;
      working memory. Participants will be randomized to active or sham stimulation and will&#xD;
      complete a series of cognitive tests both during and after stimulation.&#xD;
&#xD;
      Tolerability and blinding will also be evaluated using standard side effect questionnaires.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2016</start_date>
  <completion_date type="Actual">October 2017</completion_date>
  <primary_completion_date type="Actual">June 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Object Location Touchscreen Task (Version C) Free Recall Total Error</measure>
    <time_frame>15 minutes after encoding</time_frame>
    <description>The Object Location Touchscreen Task (OLTT) is an ecologically relevant measure of object location association memory. The OLTT requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Free Recall, participants are given a black screen and asked to touch the area of the screen an object was located. Total Score is the sum of error for all 15 trials. Lower scores represent better performance.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Object Location Touchscreen Task (Version C) Free Recall Average Error</measure>
    <time_frame>15 minutes after encoding</time_frame>
    <description>The Object Location Touchscreen Task (OLTT) is a measure of object location association memory. The OLTT requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Free Recall, participants are given a blank screen and asked to touch the area of the screen an object was located. Average Score is the average error across all 15 trials. Lower scores represent better performance.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Object Location Touchscreen Task (Version C) Free Recall Average Time to Respond</measure>
    <time_frame>15 minutes after encoding</time_frame>
    <description>The Object Location Touchscreen Task (OLTT) is a measure of object location association memory. The OLTT requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Free Recall, participants are given a blank screen and asked to touch the area of the screen an object was located. Average Time is the average latency to respond across all 15 trials. Lower scores represent faster responses.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Object Location Touchscreen Task (Version C) Cued Recall Total Error</measure>
    <time_frame>15 minutes after encoding</time_frame>
    <description>The Object Location Touchscreen Task (OLTT) requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Cued Recall, participants are shown the &quot;room&quot; or environment on the screen and asked to touch the area of the screen an object was located. Total Score is the sum of error for all 15 trials. Lower scores represent better performance.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Object Location Touchscreen Task (Version C) Cued Recall Average Error</measure>
    <time_frame>15 minutes after encoding</time_frame>
    <description>The Object Location Touchscreen Task (OLTT) requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Cued Recall, participants are shown the &quot;room&quot; or environment on the screen and asked to touch the area of the screen an object was located. Average Score is the average error across all 15 trials. Lower scores represent better performance.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Object Location Touchscreen Task (Version C) Cued Recall Average Time to Respond</measure>
    <time_frame>15 minutes after encoding</time_frame>
    <description>The Object Location Touchscreen Task (OLTT) requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Cued Recall, participants are shown the &quot;room&quot; or environment on the screen and asked to touch the area of the screen an object was located. Average Time is the average latency to respond across all 15 trials. Lower scores represent faster responses.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Object Location Touchscreen Task (Version C) Recognition Total Correct</measure>
    <time_frame>15 minutes after encoding</time_frame>
    <description>The Object Location Touchscreen Task (OLTT) requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Recognition, participants are asked to select the correct location of an object from three options on the screen. Recognition total is the number of correct selections on all 15 trials. Higher scores represent better performance.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Object Location Touchscreen Task (Version C) Recognition Average Time to Respond</measure>
    <time_frame>15 minutes after encoding</time_frame>
    <description>The Object Location Touchscreen Task (OLTT) requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Recognition, participants are asked to select the correct location of an object from three options on the screen. Recognition Average Response Time is the average latency to respond across all 15 trials. Lower scores represent faster responses.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Performance (d') on a Simple Attention (0-back) Test</measure>
    <time_frame>30 minutes post-stimulation</time_frame>
    <description>The n-back is a well validated measure of working memory. During 0-back, participants are asked to respond by pressing a key when the picture on the screen is the same as the given target (e.g., a cow). Discriminability (d') is a measure of signal detection that accounts for signal to noise ratio. Higher scores represent better discriminability.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Performance (d') on a Working Memory (2-back) Test</measure>
    <time_frame>30 minutes post-stimulation</time_frame>
    <description>The n-back is a well validated measure of working memory. During 2-back, participants are asked to respond when a picture shown is the exact same as two items ago. Discriminability (d') is a measure of signal detection that accounts for signal to noise ratio. Higher scores represent better discriminability.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Performance (d') on a Working Memory (Semantic 2-back) Test</measure>
    <time_frame>30 minutes post-stimulation</time_frame>
    <description>The n-back is a well validated measure of working memory. During Semantic-back, participants are asked to respond when a picture shown is in the same semantic category as the picture two items ago (e.g., both fruits). Discriminability (d') is a measure of signal detection that accounts for signal to noise ratio. Higher scores represent better discriminability.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Calculated Working Memory Performance Accounting for Simple Attention (2-back d' Minus 0-back d')</measure>
    <time_frame>30 minutes post-stimulation</time_frame>
    <description>The n-back is a well validated measure of working memory. During 0-back, participants are asked to respond by pressing a key when the picture on the screen is the same as the given target (e.g., a cow). During 2-back, participants are asked to respond when a picture shown is the exact same as two items ago. Discriminability (d') is a measure of signal detection that accounts for signal to noise ratio. By subtracting the 0-back d', the calculated score represents a more pure working memory measure. Scores closer to zero or positive represent better working memory performance.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Calculated Working Memory Performance Accounting for Simple Attention (Semantic 2-back d' Minus 0-back d')</measure>
    <time_frame>30 minutes post-stimulation</time_frame>
    <description>The n-back is a well validated measure of working memory. During 0-back, participants are asked to respond by pressing a key when the picture on the screen is the same as the given target (e.g., a cow). During Semantic 2-back, participants are asked to respond when a picture shown is in the same semantic category as the picture two items ago (e.g., both fruits). Discriminability (d') is a measure of signal detection that accounts for signal to noise ratio. By subtracting the 0-back d', the calculated score represents a more pure working memory measure. Scores closer to zero or positive represent better working memory performance.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blinding in Total Sample</measure>
    <time_frame>~1 minute post stimulation</time_frame>
    <description>Participants were asked to estimate which group they were in (i.e., active or sham).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of Endorsement (%) for Headache Item in Active and Sham Participants Undergoing HD-tDCS Session</measure>
    <time_frame>~1 minute post stimulation</time_frame>
    <description>The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of &quot;None, Mild, Moderate, or Severe&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of Endorsement (%) for Neck Pain Item in Active and Sham Participants Undergoing HD-tDCS Session</measure>
    <time_frame>~1 minute post stimulation</time_frame>
    <description>The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of &quot;None, Mild, Moderate, or Severe&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of Endorsement (%) for Scalp Pain Item in Active and Sham Participants Undergoing HD-tDCS Session</measure>
    <time_frame>~1 minute post stimulation</time_frame>
    <description>The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of &quot;None, Mild, Moderate, or Severe&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of Endorsement (%) for Tingling Item in Active and Sham Participants Undergoing HD-tDCS Session</measure>
    <time_frame>~1 minute post stimulation</time_frame>
    <description>The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of &quot;None, Mild, Moderate, or Severe&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of Endorsement (%) for Itching Item in Active and Sham Participants Undergoing HD-tDCS Session</measure>
    <time_frame>~1 minute post stimulation</time_frame>
    <description>The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of &quot;None, Mild, Moderate, or Severe&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of Endorsement (%) for Burning Item in Active and Sham Participants Undergoing HD-tDCS Session</measure>
    <time_frame>~1 minute post stimulation</time_frame>
    <description>The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of &quot;None, Mild, Moderate, or Severe&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of Endorsement (%) for Skin Redness Item in Active and Sham Participants Undergoing HD-tDCS Session</measure>
    <time_frame>~1 minute post stimulation</time_frame>
    <description>The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of &quot;None, Mild, Moderate, or Severe&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of Endorsement (%) for Sleepiness Item in Active and Sham Participants Undergoing HD-tDCS Session</measure>
    <time_frame>~1 minute post stimulation</time_frame>
    <description>The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of &quot;None, Mild, Moderate, or Severe&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of Endorsement (%) for Concentration Changes Item in Active and Sham Participants Undergoing HD-tDCS Session</measure>
    <time_frame>~1 minute post stimulation</time_frame>
    <description>The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of &quot;None, Mild, Moderate, or Severe&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of Endorsement (%) for Mood Changes Item in Active and Sham Participants Undergoing HD-tDCS Session</measure>
    <time_frame>~1 minute post stimulation</time_frame>
    <description>The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of &quot;None, Mild, Moderate, or Severe&quot;.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Cognitive Change</condition>
  <arm_group>
    <arm_group_label>Active HD-tDCS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive &quot;real&quot; HD-tDCS (3 milliamps for 20 minutes) for a single session.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham HD-tDCS</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Active HD-tDCS</intervention_name>
    <description>Participants will receive active HD-tDCS at 3mA for 20 minutes</description>
    <arm_group_label>Active HD-tDCS</arm_group_label>
    <other_name>HD-tDCS</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham HD-tDCS</intervention_name>
    <description>Participants will receive sham HD-tDCS</description>
    <arm_group_label>Sham HD-tDCS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Individuals with intact cognitive functioning.&#xD;
&#xD;
          2. Participants will be age 50 or older.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Individuals with a documented history of cognitive impairment.&#xD;
&#xD;
          2. A history of serious mental illness (e.g., bipolar disorder, schizophrenia, axis 2&#xD;
             disorders)&#xD;
&#xD;
          3. Sensory or motor impairments that limit the ability to take part in the study&#xD;
&#xD;
          4. A significant history or current use of alcohol or drug abuse/dependence&#xD;
&#xD;
          5. Those who are currently pregnant (if there is a question of pregnancy, pregnancy tests&#xD;
             will be available for participants at no charge)&#xD;
&#xD;
          6. Participants with an Mini Mental State Examination score &lt;24 at screening.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Benjamin M Hampstead, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Michigan - Department of Psychiatry</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Brunoni AR, Amadera J, Berbel B, Volz MS, Rizzerio BG, Fregni F. A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. Int J Neuropsychopharmacol. 2011 Sep;14(8):1133-45. doi: 10.1017/S1461145710001690. Epub 2011 Feb 15.</citation>
    <PMID>21320389</PMID>
  </reference>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>October 24, 2016</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <results_first_submitted>May 18, 2018</results_first_submitted>
  <results_first_submitted_qc>July 17, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">August 16, 2018</results_first_posted>
  <last_update_submitted>July 17, 2018</last_update_submitted>
  <last_update_submitted_qc>July 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 16, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Benjamin Hampstead, PhD</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 25, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/54/NCT03034954/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Two participants were excluded after consent due to failing the tDCS safety screen. One participant endorsed a skin condition with lesions at site of electrode placement. One participant disclosed a prior head injury.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Active HD-tDCS</title>
          <description>Participants will receive &quot;real&quot; HD-tDCS (3 milliamps for 20 minutes) for a single session.&#xD;
Active HD-tDCS: Participants will receive active HD-tDCS at 3mA for 20 minutes</description>
        </group>
        <group group_id="P2">
          <title>Sham HD-tDCS</title>
          <description>Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session.&#xD;
Sham HD-tDCS: Participants will receive sham HD-tDCS</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Machine malfunction; did not reach 3 mA</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>One participant was a statistical outlier for several behavioral measures and was excluded from baseline data and all analyses</population>
      <group_list>
        <group group_id="B1">
          <title>Active HD-tDCS</title>
          <description>Participants will receive &quot;real&quot; HD-tDCS (3 milliamps for 20 minutes) for a single session.&#xD;
Active HD-tDCS: Participants will receive active HD-tDCS at 3mA for 20 minutes</description>
        </group>
        <group group_id="B2">
          <title>Sham HD-tDCS</title>
          <description>Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session.&#xD;
Sham HD-tDCS: Participants will receive sham HD-tDCS</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="19"/>
            <count group_id="B2" value="21"/>
            <count group_id="B3" value="40"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="66.42" spread="8.546"/>
                    <measurement group_id="B2" value="65.38" spread="10.604"/>
                    <measurement group_id="B3" value="65.88" spread="9.573"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Mini-Mental State Examination</title>
          <description>The Mini Mental-State Examination is a 30-item global cognitive screen. Scores range from 0-30 with higher scores represent better performances and scores 23 and below are suggestive of cognitive impairment.</description>
          <population>Participants were not screened if an MMSE was completed within the past six months as part of their involvement with the Michigan Alzheimer's Disease Center (n = 2)</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                    <count group_id="B2" value="19"/>
                    <count group_id="B3" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28.58" spread="1.216"/>
                    <measurement group_id="B2" value="28.37" spread="1.212"/>
                    <measurement group_id="B3" value="28.47" spread="1.202"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Education</title>
          <population>Missing data for two participants</population>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="17"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16.82" spread="1.59"/>
                    <measurement group_id="B2" value="16.48" spread="2.089"/>
                    <measurement group_id="B3" value="16.63" spread="1.866"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Impedance</title>
          <description>The first impedance reading averaged across all five electrodes. The unit measured is in &quot;Quality Units&quot; as produced by the Soterix transcranial direct current stimulation machine, which is a proprietary measurement of impedance. Lower values represent less impedance.</description>
          <units>quality units</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.9512" spread="0.4004"/>
                    <measurement group_id="B2" value="0.8939" spread=".06314"/>
                    <measurement group_id="B3" value="0.921" spread="0.528"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Object Location Touchscreen Task (Version B) Free Recall Total Error</title>
          <description>The Object Location Touchscreen Task (OLTT) is an ecologically relevant measure of object location association memory. The OLTT requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Free Recall, participants are given a black screen and asked to touch the area of the screen an object was located. Total Score is the sum of error for all 15 trials. Lower scores represent better performance.</description>
          <units>centimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="115.27" spread="44.445"/>
                    <measurement group_id="B2" value="102.534" spread="6.835"/>
                    <measurement group_id="B3" value="108.583" spread="7.239"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Object Location Touchscreen Task (Version B) Free Recall Average Error</title>
          <description>The Object Location Touchscreen Task (OLTT) is a measure of object location association memory. The OLTT requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Free Recall, participants are given a blank screen and asked to touch the area of the screen an object was located. Average Score is the average error across all 15 trials. Lower scores represent better performance.</description>
          <units>centimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.685" spread="2.963"/>
                    <measurement group_id="B2" value="6.835" spread="2.97"/>
                    <measurement group_id="B3" value="7.239" spread="2.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Object Location Touchscreen Task (Version B) Free Recall Average Time to Respond</title>
          <description>The Object Location Touchscreen Task (OLTT) is a measure of object location association memory. The OLTT requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Free Recall, participants are given a blank screen and asked to touch the area of the screen an object was located. Average Time is the average latency to respond across all 15 trials. Lower scores represent faster responses.</description>
          <units>milliseconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3796.361" spread="1188.015"/>
                    <measurement group_id="B2" value="4921.558" spread="2306.631"/>
                    <measurement group_id="B3" value="4387.09" spread="1924.503"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Object Location Touchscreen Task (Version B) Cued Recall Total Error</title>
          <description>The OLTT requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Cued Recall, participants are shown the &quot;room&quot; or environment on the screen and asked to touch the area of the screen an object was located. Total Score is the sum of error for all 15 trials. Lower scores represent better performance.</description>
          <units>centimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="74.513" spread="51.385"/>
                    <measurement group_id="B2" value="45.055" spread="38.61"/>
                    <measurement group_id="B3" value="59.048" spread="46.958"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Object Location Touchscreen Task (Version B) Cued Recall Average Error</title>
          <description>The OLTT requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Cued Recall, participants are shown the &quot;room&quot; or environment on the screen and asked to touch the area of the screen an object was located. Average Score is the average error across all 15 trials. Lower scores represent better performance.</description>
          <units>centimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.971" spread="3.422"/>
                    <measurement group_id="B2" value="3.002" spread="2.574"/>
                    <measurement group_id="B3" value="3.937" spread="3.129"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Object Location Touchscreen Task (Version B) Cued Recall Average Time to Respond</title>
          <description>The OLTT requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Cued Recall, participants are shown the &quot;room&quot; or environment on the screen and asked to touch the area of the screen an object was located. Average Time is the average latency to respond across all 15 trials. Lower scores represent faster responses.</description>
          <units>milliseconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3855.83" spread="2452.1"/>
                    <measurement group_id="B2" value="3307.879" spread="1605.689"/>
                    <measurement group_id="B3" value="3568.155" spread="2043.063"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Object Location Touchscreen Task (Version B) Recognition Total Correct</title>
          <description>The OLTT requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Recognition, participants are asked to select the correct location of an object from three options on the screen. Recognition total is the number of correct selections on all 15 trials. Higher scores represent better performance.</description>
          <units>number of correct answers</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13.11" spread="1.941"/>
                    <measurement group_id="B2" value="14.05" spread="1.322"/>
                    <measurement group_id="B3" value="13.6" spread="1.692"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Object Location Touchscreen Task (Version B) Recognition Average Time to Respond</title>
          <description>The OLTT requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Recognition, participants are asked to select the correct location of an object from three options on the screen. Recognition Average Response Time is the average latency to respond across all 15 trials. Lower scores represent faster responses.</description>
          <units>milliseconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3005.095" spread="1807.47"/>
                    <measurement group_id="B2" value="2456.063" spread="1164.46"/>
                    <measurement group_id="B3" value="2716.853" spread="1510.062"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Object Location Touchscreen Task (Version C) Free Recall Total Error</title>
        <description>The Object Location Touchscreen Task (OLTT) is an ecologically relevant measure of object location association memory. The OLTT requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Free Recall, participants are given a black screen and asked to touch the area of the screen an object was located. Total Score is the sum of error for all 15 trials. Lower scores represent better performance.</description>
        <time_frame>15 minutes after encoding</time_frame>
        <population>Missing data for one participant</population>
        <group_list>
          <group group_id="O1">
            <title>Active HD-tDCS</title>
            <description>Participants will receive &quot;real&quot; HD-tDCS (3 milliamps for 20 minutes) for a single session.&#xD;
Active HD-tDCS: Participants will receive active HD-tDCS at 3mA for 20 minutes</description>
          </group>
          <group group_id="O2">
            <title>Sham HD-tDCS</title>
            <description>Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session.&#xD;
Sham HD-tDCS: Participants will receive sham HD-tDCS</description>
          </group>
        </group_list>
        <measure>
          <title>Object Location Touchscreen Task (Version C) Free Recall Total Error</title>
          <description>The Object Location Touchscreen Task (OLTT) is an ecologically relevant measure of object location association memory. The OLTT requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Free Recall, participants are given a black screen and asked to touch the area of the screen an object was located. Total Score is the sum of error for all 15 trials. Lower scores represent better performance.</description>
          <population>Missing data for one participant</population>
          <units>centimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="121.498" spread="26.366"/>
                    <measurement group_id="O2" value="99.77" spread="27.845"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>We used a multivariate statistic to compare OLTT means (Free Recall Total Error, Free Recall Average Error, Cued Recall Total Error, Cued Recall Average Error, Recognition Total Correct) at baseline (Version B) to post HD-tDCS OLTT means (Version C), by groups (active vs. sham). The overall statistic represents the simultaneous comparison of baseline OLTT measures to post HD-tDCS OLTT measures.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.300</p_value>
            <p_value_desc>Reported p-value represents Time (baseline to post-tDCS) x Condition (Active or Sham) interaction for all OLTT Accuracy Measures. If the multivariate statistic is not significant no univariate statistical analyses are completed.</p_value_desc>
            <method>Repeated Measures ANOVA</method>
            <method_desc>repeated measures (OLTT baseline and post-tDCS); between-subjects (active vs. sham)</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Object Location Touchscreen Task (Version C) Free Recall Average Error</title>
        <description>The Object Location Touchscreen Task (OLTT) is a measure of object location association memory. The OLTT requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Free Recall, participants are given a blank screen and asked to touch the area of the screen an object was located. Average Score is the average error across all 15 trials. Lower scores represent better performance.</description>
        <time_frame>15 minutes after encoding</time_frame>
        <population>Missing data for one participant</population>
        <group_list>
          <group group_id="O1">
            <title>Active HD-tDCS</title>
            <description>Participants will receive &quot;real&quot; HD-tDCS (3 milliamps for 20 minutes) for a single session.&#xD;
Active HD-tDCS: Participants will receive active HD-tDCS at 3mA for 20 minutes</description>
          </group>
          <group group_id="O2">
            <title>Sham HD-tDCS</title>
            <description>Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session.&#xD;
Sham HD-tDCS: Participants will receive sham HD-tDCS</description>
          </group>
        </group_list>
        <measure>
          <title>Object Location Touchscreen Task (Version C) Free Recall Average Error</title>
          <description>The Object Location Touchscreen Task (OLTT) is a measure of object location association memory. The OLTT requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Free Recall, participants are given a blank screen and asked to touch the area of the screen an object was located. Average Score is the average error across all 15 trials. Lower scores represent better performance.</description>
          <population>Missing data for one participant</population>
          <units>centimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.099" spread="1.757"/>
                    <measurement group_id="O2" value="6.652" spread="1.856"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Object Location Touchscreen Task (Version C) Free Recall Average Time to Respond</title>
        <description>The Object Location Touchscreen Task (OLTT) is a measure of object location association memory. The OLTT requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Free Recall, participants are given a blank screen and asked to touch the area of the screen an object was located. Average Time is the average latency to respond across all 15 trials. Lower scores represent faster responses.</description>
        <time_frame>15 minutes after encoding</time_frame>
        <population>Missing data for one participant</population>
        <group_list>
          <group group_id="O1">
            <title>Active HD-tDCS</title>
            <description>Participants will receive &quot;real&quot; HD-tDCS (3 milliamps for 20 minutes) for a single session.&#xD;
Active HD-tDCS: Participants will receive active HD-tDCS at 3mA for 20 minutes</description>
          </group>
          <group group_id="O2">
            <title>Sham HD-tDCS</title>
            <description>Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session.&#xD;
Sham HD-tDCS: Participants will receive sham HD-tDCS</description>
          </group>
        </group_list>
        <measure>
          <title>Object Location Touchscreen Task (Version C) Free Recall Average Time to Respond</title>
          <description>The Object Location Touchscreen Task (OLTT) is a measure of object location association memory. The OLTT requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Free Recall, participants are given a blank screen and asked to touch the area of the screen an object was located. Average Time is the average latency to respond across all 15 trials. Lower scores represent faster responses.</description>
          <population>Missing data for one participant</population>
          <units>milliseconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3419.878" spread="1690.354"/>
                    <measurement group_id="O2" value="3029.648" spread="1572.416"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>A Repeated Measures ANOVA was used to compare baseline OLTT (Version B) to post-tDCS OLTT (Version C) across the treatment groups (Active vs. Sham). The multivariate analyses included OLTT Response Times (i.e., Free Recall Average Response Time, Cued Recall Average Response Time, Recognition Average Response Time)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.044</p_value>
            <p_value_desc>Statistic represents the interaction between Time (baseline to post-tDCS) by Condition (Active vs. Sham).</p_value_desc>
            <method>Repeated Measures ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Univariate analysis of the OLTT Free Recall Average Time to Respond following significant multivariate repeated measures ANOVA comparing baseline OLTT (Version B) to post-tDCS OLTT (Version C) across the treatment groups (Active vs. Sham).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.006</p_value>
            <method>Repeated Measures ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Object Location Touchscreen Task (Version C) Cued Recall Total Error</title>
        <description>The Object Location Touchscreen Task (OLTT) requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Cued Recall, participants are shown the &quot;room&quot; or environment on the screen and asked to touch the area of the screen an object was located. Total Score is the sum of error for all 15 trials. Lower scores represent better performance.</description>
        <time_frame>15 minutes after encoding</time_frame>
        <population>Missing data for one participant</population>
        <group_list>
          <group group_id="O1">
            <title>Active HD-tDCS</title>
            <description>Participants will receive &quot;real&quot; HD-tDCS (3 milliamps for 20 minutes) for a single session.&#xD;
Active HD-tDCS: Participants will receive active HD-tDCS at 3mA for 20 minutes</description>
          </group>
          <group group_id="O2">
            <title>Sham HD-tDCS</title>
            <description>Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session.&#xD;
Sham HD-tDCS: Participants will receive sham HD-tDCS</description>
          </group>
        </group_list>
        <measure>
          <title>Object Location Touchscreen Task (Version C) Cued Recall Total Error</title>
          <description>The Object Location Touchscreen Task (OLTT) requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Cued Recall, participants are shown the &quot;room&quot; or environment on the screen and asked to touch the area of the screen an object was located. Total Score is the sum of error for all 15 trials. Lower scores represent better performance.</description>
          <population>Missing data for one participant</population>
          <units>centimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.806" spread="29.303"/>
                    <measurement group_id="O2" value="43.775" spread="29.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Object Location Touchscreen Task (Version C) Cued Recall Average Error</title>
        <description>The Object Location Touchscreen Task (OLTT) requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Cued Recall, participants are shown the &quot;room&quot; or environment on the screen and asked to touch the area of the screen an object was located. Average Score is the average error across all 15 trials. Lower scores represent better performance.</description>
        <time_frame>15 minutes after encoding</time_frame>
        <population>Missing data for one participant</population>
        <group_list>
          <group group_id="O1">
            <title>Active HD-tDCS</title>
            <description>Participants will receive &quot;real&quot; HD-tDCS (3 milliamps for 20 minutes) for a single session.&#xD;
Active HD-tDCS: Participants will receive active HD-tDCS at 3mA for 20 minutes</description>
          </group>
          <group group_id="O2">
            <title>Sham HD-tDCS</title>
            <description>Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session.&#xD;
Sham HD-tDCS: Participants will receive sham HD-tDCS</description>
          </group>
        </group_list>
        <measure>
          <title>Object Location Touchscreen Task (Version C) Cued Recall Average Error</title>
          <description>The Object Location Touchscreen Task (OLTT) requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Cued Recall, participants are shown the &quot;room&quot; or environment on the screen and asked to touch the area of the screen an object was located. Average Score is the average error across all 15 trials. Lower scores represent better performance.</description>
          <population>Missing data for one participant</population>
          <units>centimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.453" spread="1.954"/>
                    <measurement group_id="O2" value="2.919" spread="1.954"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Object Location Touchscreen Task (Version C) Cued Recall Average Time to Respond</title>
        <description>The Object Location Touchscreen Task (OLTT) requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Cued Recall, participants are shown the &quot;room&quot; or environment on the screen and asked to touch the area of the screen an object was located. Average Time is the average latency to respond across all 15 trials. Lower scores represent faster responses.</description>
        <time_frame>15 minutes after encoding</time_frame>
        <population>Missing data for one participant</population>
        <group_list>
          <group group_id="O1">
            <title>Active HD-tDCS</title>
            <description>Participants will receive &quot;real&quot; HD-tDCS (3 milliamps for 20 minutes) for a single session.&#xD;
Active HD-tDCS: Participants will receive active HD-tDCS at 3mA for 20 minutes</description>
          </group>
          <group group_id="O2">
            <title>Sham HD-tDCS</title>
            <description>Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session.&#xD;
Sham HD-tDCS: Participants will receive sham HD-tDCS</description>
          </group>
        </group_list>
        <measure>
          <title>Object Location Touchscreen Task (Version C) Cued Recall Average Time to Respond</title>
          <description>The Object Location Touchscreen Task (OLTT) requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Cued Recall, participants are shown the &quot;room&quot; or environment on the screen and asked to touch the area of the screen an object was located. Average Time is the average latency to respond across all 15 trials. Lower scores represent faster responses.</description>
          <population>Missing data for one participant</population>
          <units>milliseconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3991.659" spread="2218.596"/>
                    <measurement group_id="O2" value="2666.858" spread="866.887"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Univariate analysis of the OLTT Cued Recall Average Time to Respond following significant multivariate repeated measures ANOVA comparing baseline OLTT (Version B) to post-tDCS OLTT (Version C) across the treatment groups (Active vs. Sham).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.15</p_value>
            <method>Repeated Measures ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Object Location Touchscreen Task (Version C) Recognition Total Correct</title>
        <description>The Object Location Touchscreen Task (OLTT) requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Recognition, participants are asked to select the correct location of an object from three options on the screen. Recognition total is the number of correct selections on all 15 trials. Higher scores represent better performance.</description>
        <time_frame>15 minutes after encoding</time_frame>
        <population>Missing data for one participant</population>
        <group_list>
          <group group_id="O1">
            <title>Active HD-tDCS</title>
            <description>Participants will receive &quot;real&quot; HD-tDCS (3 milliamps for 20 minutes) for a single session.&#xD;
Active HD-tDCS: Participants will receive active HD-tDCS at 3mA for 20 minutes</description>
          </group>
          <group group_id="O2">
            <title>Sham HD-tDCS</title>
            <description>Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session.&#xD;
Sham HD-tDCS: Participants will receive sham HD-tDCS</description>
          </group>
        </group_list>
        <measure>
          <title>Object Location Touchscreen Task (Version C) Recognition Total Correct</title>
          <description>The Object Location Touchscreen Task (OLTT) requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Recognition, participants are asked to select the correct location of an object from three options on the screen. Recognition total is the number of correct selections on all 15 trials. Higher scores represent better performance.</description>
          <population>Missing data for one participant</population>
          <units>number of correct answers</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.79" spread="1.932"/>
                    <measurement group_id="O2" value="13.45" spread="1.669"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Object Location Touchscreen Task (Version C) Recognition Average Time to Respond</title>
        <description>The Object Location Touchscreen Task (OLTT) requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Recognition, participants are asked to select the correct location of an object from three options on the screen. Recognition Average Response Time is the average latency to respond across all 15 trials. Lower scores represent faster responses.</description>
        <time_frame>15 minutes after encoding</time_frame>
        <population>Missing data for one participant</population>
        <group_list>
          <group group_id="O1">
            <title>Active HD-tDCS</title>
            <description>Participants will receive &quot;real&quot; HD-tDCS (3 milliamps for 20 minutes) for a single session.&#xD;
Active HD-tDCS: Participants will receive active HD-tDCS at 3mA for 20 minutes</description>
          </group>
          <group group_id="O2">
            <title>Sham HD-tDCS</title>
            <description>Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session.&#xD;
Sham HD-tDCS: Participants will receive sham HD-tDCS</description>
          </group>
        </group_list>
        <measure>
          <title>Object Location Touchscreen Task (Version C) Recognition Average Time to Respond</title>
          <description>The Object Location Touchscreen Task (OLTT) requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Recognition, participants are asked to select the correct location of an object from three options on the screen. Recognition Average Response Time is the average latency to respond across all 15 trials. Lower scores represent faster responses.</description>
          <population>Missing data for one participant</population>
          <units>milliseconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2804.459" spread="1244.249"/>
                    <measurement group_id="O2" value="1903.39" spread="843.244"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Univariate analysis of the OLTT Recognition Average Time to Respond following significant multivariate repeated measures ANOVA comparing baseline OLTT (Version B) to post-tDCS OLTT (Version C) across the treatment groups (Active vs. Sham).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.3</p_value>
            <method>Repeated Measures ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Performance (d') on a Simple Attention (0-back) Test</title>
        <description>The n-back is a well validated measure of working memory. During 0-back, participants are asked to respond by pressing a key when the picture on the screen is the same as the given target (e.g., a cow). Discriminability (d') is a measure of signal detection that accounts for signal to noise ratio. Higher scores represent better discriminability.</description>
        <time_frame>30 minutes post-stimulation</time_frame>
        <population>missing data for two participants</population>
        <group_list>
          <group group_id="O1">
            <title>Active HD-tDCS</title>
            <description>Participants will receive &quot;real&quot; HD-tDCS (3 milliamps for 20 minutes) for a single session.&#xD;
Active HD-tDCS: Participants will receive active HD-tDCS at 3mA for 20 minutes</description>
          </group>
          <group group_id="O2">
            <title>Sham HD-tDCS</title>
            <description>Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session.&#xD;
Sham HD-tDCS: Participants will receive sham HD-tDCS</description>
          </group>
        </group_list>
        <measure>
          <title>Performance (d') on a Simple Attention (0-back) Test</title>
          <description>The n-back is a well validated measure of working memory. During 0-back, participants are asked to respond by pressing a key when the picture on the screen is the same as the given target (e.g., a cow). Discriminability (d') is a measure of signal detection that accounts for signal to noise ratio. Higher scores represent better discriminability.</description>
          <population>missing data for two participants</population>
          <units>d'</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.26" spread=".231"/>
                    <measurement group_id="O2" value="4.25" spread=".219"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Performance (d') on a Working Memory (2-back) Test</title>
        <description>The n-back is a well validated measure of working memory. During 2-back, participants are asked to respond when a picture shown is the exact same as two items ago. Discriminability (d') is a measure of signal detection that accounts for signal to noise ratio. Higher scores represent better discriminability.</description>
        <time_frame>30 minutes post-stimulation</time_frame>
        <population>missing data for two participants</population>
        <group_list>
          <group group_id="O1">
            <title>Active HD-tDCS</title>
            <description>Participants will receive &quot;real&quot; HD-tDCS (3 milliamps for 20 minutes) for a single session.&#xD;
Active HD-tDCS: Participants will receive active HD-tDCS at 3mA for 20 minutes</description>
          </group>
          <group group_id="O2">
            <title>Sham HD-tDCS</title>
            <description>Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session.&#xD;
Sham HD-tDCS: Participants will receive sham HD-tDCS</description>
          </group>
        </group_list>
        <measure>
          <title>Performance (d') on a Working Memory (2-back) Test</title>
          <description>The n-back is a well validated measure of working memory. During 2-back, participants are asked to respond when a picture shown is the exact same as two items ago. Discriminability (d') is a measure of signal detection that accounts for signal to noise ratio. Higher scores represent better discriminability.</description>
          <population>missing data for two participants</population>
          <units>d'</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.05" spread=".508"/>
                    <measurement group_id="O2" value="2.94" spread=".675"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Performance (d') on a Working Memory (Semantic 2-back) Test</title>
        <description>The n-back is a well validated measure of working memory. During Semantic-back, participants are asked to respond when a picture shown is in the same semantic category as the picture two items ago (e.g., both fruits). Discriminability (d') is a measure of signal detection that accounts for signal to noise ratio. Higher scores represent better discriminability.</description>
        <time_frame>30 minutes post-stimulation</time_frame>
        <population>missing data for eleven participants (5 Active; 6 Sham) due to Eprime miscalculation</population>
        <group_list>
          <group group_id="O1">
            <title>Active HD-tDCS</title>
            <description>Participants will receive &quot;real&quot; HD-tDCS (3 milliamps for 20 minutes) for a single session.&#xD;
Active HD-tDCS: Participants will receive active HD-tDCS at 3mA for 20 minutes</description>
          </group>
          <group group_id="O2">
            <title>Sham HD-tDCS</title>
            <description>Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session.&#xD;
Sham HD-tDCS: Participants will receive sham HD-tDCS</description>
          </group>
        </group_list>
        <measure>
          <title>Performance (d') on a Working Memory (Semantic 2-back) Test</title>
          <description>The n-back is a well validated measure of working memory. During Semantic-back, participants are asked to respond when a picture shown is in the same semantic category as the picture two items ago (e.g., both fruits). Discriminability (d') is a measure of signal detection that accounts for signal to noise ratio. Higher scores represent better discriminability.</description>
          <population>missing data for eleven participants (5 Active; 6 Sham) due to Eprime miscalculation</population>
          <units>d'</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.518" spread=".537"/>
                    <measurement group_id="O2" value="1.69" spread=".495"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Calculated Working Memory Performance Accounting for Simple Attention (2-back d' Minus 0-back d')</title>
        <description>The n-back is a well validated measure of working memory. During 0-back, participants are asked to respond by pressing a key when the picture on the screen is the same as the given target (e.g., a cow). During 2-back, participants are asked to respond when a picture shown is the exact same as two items ago. Discriminability (d') is a measure of signal detection that accounts for signal to noise ratio. By subtracting the 0-back d', the calculated score represents a more pure working memory measure. Scores closer to zero or positive represent better working memory performance.</description>
        <time_frame>30 minutes post-stimulation</time_frame>
        <population>missing data for 12 participants: 11 2-back (5 Active; 6 sham) due to Eprime miscalculation &amp; one 0-back (Active)</population>
        <group_list>
          <group group_id="O1">
            <title>Active HD-tDCS</title>
            <description>Participants will receive &quot;real&quot; HD-tDCS (3 milliamps for 20 minutes) for a single session.&#xD;
Active HD-tDCS: Participants will receive active HD-tDCS at 3mA for 20 minutes</description>
          </group>
          <group group_id="O2">
            <title>Sham HD-tDCS</title>
            <description>Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session.&#xD;
Sham HD-tDCS: Participants will receive sham HD-tDCS</description>
          </group>
        </group_list>
        <measure>
          <title>Calculated Working Memory Performance Accounting for Simple Attention (2-back d' Minus 0-back d')</title>
          <description>The n-back is a well validated measure of working memory. During 0-back, participants are asked to respond by pressing a key when the picture on the screen is the same as the given target (e.g., a cow). During 2-back, participants are asked to respond when a picture shown is the exact same as two items ago. Discriminability (d') is a measure of signal detection that accounts for signal to noise ratio. By subtracting the 0-back d', the calculated score represents a more pure working memory measure. Scores closer to zero or positive represent better working memory performance.</description>
          <population>missing data for 12 participants: 11 2-back (5 Active; 6 sham) due to Eprime miscalculation &amp; one 0-back (Active)</population>
          <units>d'</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.130" spread=".629"/>
                    <measurement group_id="O2" value="-1.31" spread=".675"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Calculated Working Memory Performance Accounting for Simple Attention (Semantic 2-back d' Minus 0-back d')</title>
        <description>The n-back is a well validated measure of working memory. During 0-back, participants are asked to respond by pressing a key when the picture on the screen is the same as the given target (e.g., a cow). During Semantic 2-back, participants are asked to respond when a picture shown is in the same semantic category as the picture two items ago (e.g., both fruits). Discriminability (d') is a measure of signal detection that accounts for signal to noise ratio. By subtracting the 0-back d', the calculated score represents a more pure working memory measure. Scores closer to zero or positive represent better working memory performance.</description>
        <time_frame>30 minutes post-stimulation</time_frame>
        <population>missing data for two participants</population>
        <group_list>
          <group group_id="O1">
            <title>Active HD-tDCS</title>
            <description>Participants will receive &quot;real&quot; HD-tDCS (3 milliamps for 20 minutes) for a single session.&#xD;
Active HD-tDCS: Participants will receive active HD-tDCS at 3mA for 20 minutes</description>
          </group>
          <group group_id="O2">
            <title>Sham HD-tDCS</title>
            <description>Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session.&#xD;
Sham HD-tDCS: Participants will receive sham HD-tDCS</description>
          </group>
        </group_list>
        <measure>
          <title>Calculated Working Memory Performance Accounting for Simple Attention (Semantic 2-back d' Minus 0-back d')</title>
          <description>The n-back is a well validated measure of working memory. During 0-back, participants are asked to respond by pressing a key when the picture on the screen is the same as the given target (e.g., a cow). During Semantic 2-back, participants are asked to respond when a picture shown is in the same semantic category as the picture two items ago (e.g., both fruits). Discriminability (d') is a measure of signal detection that accounts for signal to noise ratio. By subtracting the 0-back d', the calculated score represents a more pure working memory measure. Scores closer to zero or positive represent better working memory performance.</description>
          <population>missing data for two participants</population>
          <units>d'</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.69" spread=".58"/>
                    <measurement group_id="O2" value="-2.56" spread=".47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>A Multivariate ANOVA was used to compare Active vs. Sham groups on discriminability measures (i.e. 0-back d', 2-back d', semantic 2-back d') and calculated working memory measures (i.e., 2-back d' minus 0-back d', semantic 2-back d' minus 0-back d').</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.450</p_value>
            <method>MANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Blinding in Total Sample</title>
        <description>Participants were asked to estimate which group they were in (i.e., active or sham).</description>
        <time_frame>~1 minute post stimulation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Active HD-tDCS</title>
            <description>Participants will receive &quot;real&quot; HD-tDCS (3 milliamps for 20 minutes) for a single session.&#xD;
Active HD-tDCS: Participants will receive active HD-tDCS at 3mA for 20 minutes</description>
          </group>
          <group group_id="O2">
            <title>Sham HD-tDCS</title>
            <description>Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session.&#xD;
Sham HD-tDCS: Participants will receive sham HD-tDCS</description>
          </group>
        </group_list>
        <measure>
          <title>Blinding in Total Sample</title>
          <description>Participants were asked to estimate which group they were in (i.e., active or sham).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Said Active</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Said Sham</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Said Don't Know</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Chi-squared tests were conducted to determine group differences in actual condition assignment vs. estimated/perceived condition</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.078</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Frequency of Endorsement (%) for Headache Item in Active and Sham Participants Undergoing HD-tDCS Session</title>
        <description>The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of &quot;None, Mild, Moderate, or Severe&quot;.</description>
        <time_frame>~1 minute post stimulation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Active HD-tDCS</title>
            <description>Participants will receive &quot;real&quot; HD-tDCS (3 milliamps for 20 minutes) for a single session.&#xD;
Active HD-tDCS: Participants will receive active HD-tDCS at 3mA for 20 minutes</description>
          </group>
          <group group_id="O2">
            <title>Sham HD-tDCS</title>
            <description>Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session.&#xD;
Sham HD-tDCS: Participants will receive sham HD-tDCS</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of Endorsement (%) for Headache Item in Active and Sham Participants Undergoing HD-tDCS Session</title>
          <description>The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of &quot;None, Mild, Moderate, or Severe&quot;.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Headache NONE</title>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Headache MILD</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Headache MODERATE</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Headache SEVERE</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.233</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Frequency of Endorsement (%) for Neck Pain Item in Active and Sham Participants Undergoing HD-tDCS Session</title>
        <description>The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of &quot;None, Mild, Moderate, or Severe&quot;.</description>
        <time_frame>~1 minute post stimulation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Active HD-tDCS</title>
            <description>Participants will receive &quot;real&quot; HD-tDCS (3 milliamps for 20 minutes) for a single session.&#xD;
Active HD-tDCS: Participants will receive active HD-tDCS at 3mA for 20 minutes</description>
          </group>
          <group group_id="O2">
            <title>Sham HD-tDCS</title>
            <description>Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session.&#xD;
Sham HD-tDCS: Participants will receive sham HD-tDCS</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of Endorsement (%) for Neck Pain Item in Active and Sham Participants Undergoing HD-tDCS Session</title>
          <description>The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of &quot;None, Mild, Moderate, or Severe&quot;.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Neck Pain NONE</title>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Neck Pain MILD</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Neck Pain MODERATE</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Neck Pain SEVERE</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Frequency of Endorsement (%) for Scalp Pain Item in Active and Sham Participants Undergoing HD-tDCS Session</title>
        <description>The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of &quot;None, Mild, Moderate, or Severe&quot;.</description>
        <time_frame>~1 minute post stimulation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Active HD-tDCS</title>
            <description>Participants will receive &quot;real&quot; HD-tDCS (3 milliamps for 20 minutes) for a single session.&#xD;
Active HD-tDCS: Participants will receive active HD-tDCS at 3mA for 20 minutes</description>
          </group>
          <group group_id="O2">
            <title>Sham HD-tDCS</title>
            <description>Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session.&#xD;
Sham HD-tDCS: Participants will receive sham HD-tDCS</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of Endorsement (%) for Scalp Pain Item in Active and Sham Participants Undergoing HD-tDCS Session</title>
          <description>The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of &quot;None, Mild, Moderate, or Severe&quot;.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>NONE</title>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>MILD</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>MODERATE</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>SEVERE</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.600</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Frequency of Endorsement (%) for Tingling Item in Active and Sham Participants Undergoing HD-tDCS Session</title>
        <description>The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of &quot;None, Mild, Moderate, or Severe&quot;.</description>
        <time_frame>~1 minute post stimulation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Active HD-tDCS</title>
            <description>Participants will receive &quot;real&quot; HD-tDCS (3 milliamps for 20 minutes) for a single session.&#xD;
Active HD-tDCS: Participants will receive active HD-tDCS at 3mA for 20 minutes</description>
          </group>
          <group group_id="O2">
            <title>Sham HD-tDCS</title>
            <description>Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session.&#xD;
Sham HD-tDCS: Participants will receive sham HD-tDCS</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of Endorsement (%) for Tingling Item in Active and Sham Participants Undergoing HD-tDCS Session</title>
          <description>The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of &quot;None, Mild, Moderate, or Severe&quot;.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>NONE</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>MILD</title>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>MODERATE</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>SEVERE</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.999</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Frequency of Endorsement (%) for Itching Item in Active and Sham Participants Undergoing HD-tDCS Session</title>
        <description>The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of &quot;None, Mild, Moderate, or Severe&quot;.</description>
        <time_frame>~1 minute post stimulation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Active HD-tDCS</title>
            <description>Participants will receive &quot;real&quot; HD-tDCS (3 milliamps for 20 minutes) for a single session.&#xD;
Active HD-tDCS: Participants will receive active HD-tDCS at 3mA for 20 minutes</description>
          </group>
          <group group_id="O2">
            <title>Sham HD-tDCS</title>
            <description>Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session.&#xD;
Sham HD-tDCS: Participants will receive sham HD-tDCS</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of Endorsement (%) for Itching Item in Active and Sham Participants Undergoing HD-tDCS Session</title>
          <description>The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of &quot;None, Mild, Moderate, or Severe&quot;.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>NONE</title>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>MILD</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>MODERATE</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>SEVERE</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.281</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Frequency of Endorsement (%) for Burning Item in Active and Sham Participants Undergoing HD-tDCS Session</title>
        <description>The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of &quot;None, Mild, Moderate, or Severe&quot;.</description>
        <time_frame>~1 minute post stimulation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Active HD-tDCS</title>
            <description>Participants will receive &quot;real&quot; HD-tDCS (3 milliamps for 20 minutes) for a single session.&#xD;
Active HD-tDCS: Participants will receive active HD-tDCS at 3mA for 20 minutes</description>
          </group>
          <group group_id="O2">
            <title>Sham HD-tDCS</title>
            <description>Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session.&#xD;
Sham HD-tDCS: Participants will receive sham HD-tDCS</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of Endorsement (%) for Burning Item in Active and Sham Participants Undergoing HD-tDCS Session</title>
          <description>The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of &quot;None, Mild, Moderate, or Severe&quot;.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>NONE</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>MILD</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>MODERATE</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>SEVERE</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.082</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Frequency of Endorsement (%) for Skin Redness Item in Active and Sham Participants Undergoing HD-tDCS Session</title>
        <description>The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of &quot;None, Mild, Moderate, or Severe&quot;.</description>
        <time_frame>~1 minute post stimulation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Active HD-tDCS</title>
            <description>Participants will receive &quot;real&quot; HD-tDCS (3 milliamps for 20 minutes) for a single session.&#xD;
Active HD-tDCS: Participants will receive active HD-tDCS at 3mA for 20 minutes</description>
          </group>
          <group group_id="O2">
            <title>Sham HD-tDCS</title>
            <description>Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session.&#xD;
Sham HD-tDCS: Participants will receive sham HD-tDCS</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of Endorsement (%) for Skin Redness Item in Active and Sham Participants Undergoing HD-tDCS Session</title>
          <description>The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of &quot;None, Mild, Moderate, or Severe&quot;.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>NONE</title>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>MILD</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>MODERATE</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>SEVERE</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.490</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Frequency of Endorsement (%) for Sleepiness Item in Active and Sham Participants Undergoing HD-tDCS Session</title>
        <description>The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of &quot;None, Mild, Moderate, or Severe&quot;.</description>
        <time_frame>~1 minute post stimulation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Active HD-tDCS</title>
            <description>Participants will receive &quot;real&quot; HD-tDCS (3 milliamps for 20 minutes) for a single session.&#xD;
Active HD-tDCS: Participants will receive active HD-tDCS at 3mA for 20 minutes</description>
          </group>
          <group group_id="O2">
            <title>Sham HD-tDCS</title>
            <description>Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session.&#xD;
Sham HD-tDCS: Participants will receive sham HD-tDCS</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of Endorsement (%) for Sleepiness Item in Active and Sham Participants Undergoing HD-tDCS Session</title>
          <description>The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of &quot;None, Mild, Moderate, or Severe&quot;.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>NONE</title>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>MILD</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>MODERATE</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>SEVERE</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.488</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Frequency of Endorsement (%) for Concentration Changes Item in Active and Sham Participants Undergoing HD-tDCS Session</title>
        <description>The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of &quot;None, Mild, Moderate, or Severe&quot;.</description>
        <time_frame>~1 minute post stimulation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Active HD-tDCS</title>
            <description>Participants will receive &quot;real&quot; HD-tDCS (3 milliamps for 20 minutes) for a single session.&#xD;
Active HD-tDCS: Participants will receive active HD-tDCS at 3mA for 20 minutes</description>
          </group>
          <group group_id="O2">
            <title>Sham HD-tDCS</title>
            <description>Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session.&#xD;
Sham HD-tDCS: Participants will receive sham HD-tDCS</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of Endorsement (%) for Concentration Changes Item in Active and Sham Participants Undergoing HD-tDCS Session</title>
          <description>The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of &quot;None, Mild, Moderate, or Severe&quot;.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>NONE</title>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>MILD</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>MODERATE</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>SEVERE</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.219</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Frequency of Endorsement (%) for Mood Changes Item in Active and Sham Participants Undergoing HD-tDCS Session</title>
        <description>The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of &quot;None, Mild, Moderate, or Severe&quot;.</description>
        <time_frame>~1 minute post stimulation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Active HD-tDCS</title>
            <description>Participants will receive &quot;real&quot; HD-tDCS (3 milliamps for 20 minutes) for a single session.&#xD;
Active HD-tDCS: Participants will receive active HD-tDCS at 3mA for 20 minutes</description>
          </group>
          <group group_id="O2">
            <title>Sham HD-tDCS</title>
            <description>Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session.&#xD;
Sham HD-tDCS: Participants will receive sham HD-tDCS</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of Endorsement (%) for Mood Changes Item in Active and Sham Participants Undergoing HD-tDCS Session</title>
          <description>The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of &quot;None, Mild, Moderate, or Severe&quot;.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>NONE</title>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>MILD</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>MODERATE</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>SEVERE</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events data were collected for the duration of participation (i.e., approximately 2-3 hours)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Active HD-tDCS</title>
          <description>Participants will receive &quot;real&quot; HD-tDCS (3 milliamps for 20 minutes) for a single session.&#xD;
Active HD-tDCS: Participants will receive active HD-tDCS at 3mA for 20 minutes</description>
        </group>
        <group group_id="E2">
          <title>Sham HD-tDCS</title>
          <description>Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session.&#xD;
Sham HD-tDCS: Participants will receive sham HD-tDCS</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Neck Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Sleepiness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Concentration Changes</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Mood Changes</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Scalp Pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Tingling</sub_title>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="19"/>
                <counts group_id="E2" events="14" subjects_affected="14" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Itching</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="19"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Burning sensation</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="19"/>
                <counts group_id="E2" events="14" subjects_affected="14" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Skin redness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Annalise Rahman-Filipiak</name_or_title>
      <organization>University of Michigan</organization>
      <phone>734-763-9259</phone>
      <email>rahmanam@med.umich.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03034954
org study id: HUM00111090.1 PCN
nct id: NCT03034954
lead sponsor: 
has dmc: No
As we age, a number of factors can reduce our cognitive (or thinking) abilities. This study
      will evaluate whether transcranial electrical stimulation (TES), which uses small amounts of
      electricity to modulate brain functioning, can improve cognitive abilities. Here, the effects
      of TES on working memory, learning, and memory, will be evaluated in a group of healthy older
      adults.
The primary objective is to investigate the cognitive effects of high definition anodal tDCS
      (HD-tDCS; anode at center electrode) at 3 mA (for 20 minutes) on learning, memory, and
      working memory. Participants will be randomized to active or sham stimulation and will
      complete a series of cognitive tests both during and after stimulation.

      Tolerability and blinding will also be evaluated using standard side effect questionnaires.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Object Location Touchscreen Task (Version C) Free Recall Total Error
time frame: 15 minutes after encoding
description: The Object Location Touchscreen Task (OLTT) is an ecologically relevant measure of object location association memory. The OLTT requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Free Recall, participants are given a black screen and asked to touch the area of the screen an object was located. Total Score is the sum of error for all 15 trials. Lower scores represent better performance.
measure: Object Location Touchscreen Task (Version C) Free Recall Average Error
time frame: 15 minutes after encoding
description: The Object Location Touchscreen Task (OLTT) is a measure of object location association memory. The OLTT requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Free Recall, participants are given a blank screen and asked to touch the area of the screen an object was located. Average Score is the average error across all 15 trials. Lower scores represent better performance.
measure: Object Location Touchscreen Task (Version C) Free Recall Average Time to Respond
time frame: 15 minutes after encoding
description: The Object Location Touchscreen Task (OLTT) is a measure of object location association memory. The OLTT requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Free Recall, participants are given a blank screen and asked to touch the area of the screen an object was located. Average Time is the average latency to respond across all 15 trials. Lower scores represent faster responses.
measure: Object Location Touchscreen Task (Version C) Cued Recall Total Error
time frame: 15 minutes after encoding
description: The Object Location Touchscreen Task (OLTT) requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Cued Recall, participants are shown the "room" or environment on the screen and asked to touch the area of the screen an object was located. Total Score is the sum of error for all 15 trials. Lower scores represent better performance.
measure: Object Location Touchscreen Task (Version C) Cued Recall Average Error
time frame: 15 minutes after encoding
description: The Object Location Touchscreen Task (OLTT) requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Cued Recall, participants are shown the "room" or environment on the screen and asked to touch the area of the screen an object was located. Average Score is the average error across all 15 trials. Lower scores represent better performance.
measure: Object Location Touchscreen Task (Version C) Cued Recall Average Time to Respond
time frame: 15 minutes after encoding
description: The Object Location Touchscreen Task (OLTT) requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Cued Recall, participants are shown the "room" or environment on the screen and asked to touch the area of the screen an object was located. Average Time is the average latency to respond across all 15 trials. Lower scores represent faster responses.
measure: Object Location Touchscreen Task (Version C) Recognition Total Correct
time frame: 15 minutes after encoding
description: The Object Location Touchscreen Task (OLTT) requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Recognition, participants are asked to select the correct location of an object from three options on the screen. Recognition total is the number of correct selections on all 15 trials. Higher scores represent better performance.
measure: Object Location Touchscreen Task (Version C) Recognition Average Time to Respond
time frame: 15 minutes after encoding
description: The Object Location Touchscreen Task (OLTT) requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Recognition, participants are asked to select the correct location of an object from three options on the screen. Recognition Average Response Time is the average latency to respond across all 15 trials. Lower scores represent faster responses.
measure: Performance (d') on a Simple Attention (0-back) Test
time frame: 30 minutes post-stimulation
description: The n-back is a well validated measure of working memory. During 0-back, participants are asked to respond by pressing a key when the picture on the screen is the same as the given target (e.g., a cow). Discriminability (d') is a measure of signal detection that accounts for signal to noise ratio. Higher scores represent better discriminability.
measure: Performance (d') on a Working Memory (2-back) Test
time frame: 30 minutes post-stimulation
description: The n-back is a well validated measure of working memory. During 2-back, participants are asked to respond when a picture shown is the exact same as two items ago. Discriminability (d') is a measure of signal detection that accounts for signal to noise ratio. Higher scores represent better discriminability.
measure: Performance (d') on a Working Memory (Semantic 2-back) Test
time frame: 30 minutes post-stimulation
description: The n-back is a well validated measure of working memory. During Semantic-back, participants are asked to respond when a picture shown is in the same semantic category as the picture two items ago (e.g., both fruits). Discriminability (d') is a measure of signal detection that accounts for signal to noise ratio. Higher scores represent better discriminability.
measure: Calculated Working Memory Performance Accounting for Simple Attention (2-back d' Minus 0-back d')
time frame: 30 minutes post-stimulation
description: The n-back is a well validated measure of working memory. During 0-back, participants are asked to respond by pressing a key when the picture on the screen is the same as the given target (e.g., a cow). During 2-back, participants are asked to respond when a picture shown is the exact same as two items ago. Discriminability (d') is a measure of signal detection that accounts for signal to noise ratio. By subtracting the 0-back d', the calculated score represents a more pure working memory measure. Scores closer to zero or positive represent better working memory performance.
measure: Calculated Working Memory Performance Accounting for Simple Attention (Semantic 2-back d' Minus 0-back d')
time frame: 30 minutes post-stimulation
description: The n-back is a well validated measure of working memory. During 0-back, participants are asked to respond by pressing a key when the picture on the screen is the same as the given target (e.g., a cow). During Semantic 2-back, participants are asked to respond when a picture shown is in the same semantic category as the picture two items ago (e.g., both fruits). Discriminability (d') is a measure of signal detection that accounts for signal to noise ratio. By subtracting the 0-back d', the calculated score represents a more pure working memory measure. Scores closer to zero or positive represent better working memory performance.
measure: Blinding in Total Sample
time frame: ~1 minute post stimulation
description: Participants were asked to estimate which group they were in (i.e., active or sham).
measure: Frequency of Endorsement (%) for Headache Item in Active and Sham Participants Undergoing HD-tDCS Session
time frame: ~1 minute post stimulation
description: The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of "None, Mild, Moderate, or Severe".
measure: Frequency of Endorsement (%) for Neck Pain Item in Active and Sham Participants Undergoing HD-tDCS Session
time frame: ~1 minute post stimulation
description: The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of "None, Mild, Moderate, or Severe".
measure: Frequency of Endorsement (%) for Scalp Pain Item in Active and Sham Participants Undergoing HD-tDCS Session
time frame: ~1 minute post stimulation
description: The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of "None, Mild, Moderate, or Severe".
measure: Frequency of Endorsement (%) for Tingling Item in Active and Sham Participants Undergoing HD-tDCS Session
time frame: ~1 minute post stimulation
description: The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of "None, Mild, Moderate, or Severe".
measure: Frequency of Endorsement (%) for Itching Item in Active and Sham Participants Undergoing HD-tDCS Session
time frame: ~1 minute post stimulation
description: The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of "None, Mild, Moderate, or Severe".
measure: Frequency of Endorsement (%) for Burning Item in Active and Sham Participants Undergoing HD-tDCS Session
time frame: ~1 minute post stimulation
description: The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of "None, Mild, Moderate, or Severe".
measure: Frequency of Endorsement (%) for Skin Redness Item in Active and Sham Participants Undergoing HD-tDCS Session
time frame: ~1 minute post stimulation
description: The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of "None, Mild, Moderate, or Severe".
measure: Frequency of Endorsement (%) for Sleepiness Item in Active and Sham Participants Undergoing HD-tDCS Session
time frame: ~1 minute post stimulation
description: The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of "None, Mild, Moderate, or Severe".
measure: Frequency of Endorsement (%) for Concentration Changes Item in Active and Sham Participants Undergoing HD-tDCS Session
time frame: ~1 minute post stimulation
description: The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of "None, Mild, Moderate, or Severe".
measure: Frequency of Endorsement (%) for Mood Changes Item in Active and Sham Participants Undergoing HD-tDCS Session
time frame: ~1 minute post stimulation
description: The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of "None, Mild, Moderate, or Severe".
arm group label: Active HD-tDCS
arm group type: Active Comparator
description: Participants will receive "real" HD-tDCS (3 milliamps for 20 minutes) for a single session.
arm group label: Sham HD-tDCS
arm group type: Sham Comparator
description: Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session.
intervention type: Device
intervention name: Active HD-tDCS
description: Participants will receive active HD-tDCS at 3mA for 20 minutes
arm group label: Active HD-tDCS
other name: HD-tDCS
intervention type: Device
intervention name: Sham HD-tDCS
description: Participants will receive sham HD-tDCS
arm group label: Sham HD-tDCS
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Benjamin M Hampstead, PhD
role: Principal Investigator
affiliation: University of Michigan
facility: 
country: United States
citation: Brunoni AR, Amadera J, Berbel B, Volz MS, Rizzerio BG, Fregni F. A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. Int J Neuropsychopharmacol. 2011 Sep;14(8):1133-45. doi: 10.1017/S1461145710001690. Epub 2011 Feb 15.
PMID: 21320389
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Benjamin Hampstead, PhD
investigator title: Associate Professor
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 