<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/NCT03304262</url>
  </required_header>
  <id_info>
    <org_study_id>16-410</org_study_id>
    <nct_id>NCT03304262</nct_id>
  </id_info>
  <brief_title>Metaplasticity Experimental Design and Comparison of Motor Outcome Measure Sensitivity to Change</brief_title>
  <official_title>Metaplasticity in the Human Motor Cortex: Validation of an Experimental Design and Comparison of Motor Outcome Measure Sensitivity to Change</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of New Mexico</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of New Mexico</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall objective is to validate the methodology of a metaplasticity experimental design&#xD;
      by assessing change in motor excitability after administration of priming transcranial direct&#xD;
      current stimulation (tDCS) followed by repetitive transcranial magnetic stimulation (rTMS) in&#xD;
      healthy human participants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The overall objective is to validate the methodology of a metaplasticity experimental design&#xD;
      by assessing change in motor excitability after administration of priming transcranial direct&#xD;
      current stimulation (tDCS) followed by repetitive transcranial magnetic stimulation (rTMS) in&#xD;
      healthy human participants. Our primary objective is to compare pre- and post-measures of&#xD;
      cortical excitability before priming tDCS (anodal, cathodal or sham) [M1], directly after&#xD;
      priming tDCS [M2], directly after inhibitory rTMS [M3], and 10 minutes after inhibitory rTMS&#xD;
      [M4]. Our secondary objective is to evaluate the sensitivity of motor excitability outcome&#xD;
      measures response to the noninvasive neurostimulation (e.g. rTMS and tDCS). We also aim to&#xD;
      compare pre- and post- measures of cortical excitability after inhibitory and excitatory&#xD;
      priming of the motor cortex, and to evaluate the sensitivity of motor outcome measures to&#xD;
      changes in cortical plasticity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 18, 2017</start_date>
  <completion_date type="Actual">March 31, 2018</completion_date>
  <primary_completion_date type="Actual">February 28, 2018</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>Crossover Assignment</intervention_model>
    <intervention_model_description>This is a randomized, sham-controlled, double blinded crossover trial.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Participants will be blinded to treatment group, investigator administering tDCS will be blinded to which treatment arm subject is assigned to, and the data analyst will be conducting analysis off site and is different than investigator applying stimulation.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Percent Change in MEP Amplitude</measure>
    <time_frame>assessed and reported throughout study completion pre- and post- intervention approximately 30 minutes</time_frame>
    <description>Percent Change in MEP amplitude over the first dorsal interosseous (FDI) muscle of the right hand</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cortical Silent Period</measure>
    <time_frame>tDCS + rTMS assessed and reported pre and post (approximately 10 minutes)</time_frame>
    <description>Change in length of CSP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Simple Reaction Time</measure>
    <time_frame>The final outcome will be percent change in the reaction time from pre- to post- intervention.</time_frame>
    <description>Participants will perform a simple reaction time task. This will be measured in seconds of response after a stimulus. The final outcome will be percent change in the reaction time from pre- to post- intervention.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Cathodal tDCS + rTMS then Anodal tDCS + rTMS then Sham tDCS + rTMS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participant will receive 10 minutes of cathodal tDCS between M1 and M2 timepoints, and rTMS for 900 1Hz pulses at 0.85 of Resting Motor Threshold at M2. After 1 week washout, participant will receive 10 minutes of anodal tDCS and rTMS for 900 1Hz pulses at 0.85 RMT. After 1 week washout, participant will receive 10 minutes of sham tDCS and rTMS for 900 1 Hz pulses at 0.85 RMT.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Anodal tDCS + rTMS then Sham tDCS + rTMS then Cathodal tDCS + rTMS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participant will receive 10 minutes of anodal tDCS between M1 and M2 timepoints, and rTMS for 900 1Hz pulses at 0.85 of Resting Motor Threshold at M2. After 1 week washout, participant will receive 10 minutes of sham tDCS and rTMS for 900 1 Hz pulses at 0.85 RMT. After 1 week washout, participant will receive 10 minutes of cathodal tDCS and rTMS for 900 1 Hz pulses at 0.85 RMT.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham tDCS + rTMS then Cathodal tDCS + rTMS then Anodal tDCS + rTMS</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Participant will receive 10 minutes of sham tDCS between M1 and M2 timepoints, and rTMS for 900 1Hz pulses at 0.85 of Resting Motor Threshold at M2. After 1 week washout, participant will receive 10 minutes of cathodal tDCS and rTMS for 900 1 Hz pulses at 0.85 RMT. After 1 week washout, participant will receive 10 minutes of anodal tDCS and rTMS for 900 1 Hz pulses at 0.85 RMT.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>rTMS</intervention_name>
    <description>Between time point M2 and M3, participant will receive 900 pulses of rTMS at 1Hz at 0.85 of M2 resting motor threshold.</description>
    <arm_group_label>Anodal tDCS + rTMS then Sham tDCS + rTMS then Cathodal tDCS + rTMS</arm_group_label>
    <arm_group_label>Cathodal tDCS + rTMS then Anodal tDCS + rTMS then Sham tDCS + rTMS</arm_group_label>
    <arm_group_label>Sham tDCS + rTMS then Cathodal tDCS + rTMS then Anodal tDCS + rTMS</arm_group_label>
    <other_name>rapid transcranial magnetic stimulation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must be at least 18 years of age (all genders, races, ethnicity)&#xD;
&#xD;
          -  Must have no current psychiatric or neurologic issues&#xD;
&#xD;
          -  Must not have any conditions listed in exclusion criteria&#xD;
&#xD;
          -  Must be fluent in English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of major psychiatric illness&#xD;
&#xD;
          -  Actively using neuropsychoactive medication&#xD;
&#xD;
          -  Legal or mental incompetency&#xD;
&#xD;
          -  Substance use disorder, abuse or dependence, with active use within the last three&#xD;
             months&#xD;
&#xD;
          -  Significant medical or neurological illness&#xD;
&#xD;
          -  Prior neurosurgical illness&#xD;
&#xD;
          -  Prior neurosurgical procedure&#xD;
&#xD;
          -  History of seizure&#xD;
&#xD;
          -  History of ECT or TMS treatment within the past there months&#xD;
&#xD;
          -  Presence of a pacemaker, implanted medical pump or device, metal plate, or metal&#xD;
             object in skull or eye (including shunts, dental implants, facial tattoos with&#xD;
             metallic ink)&#xD;
&#xD;
          -  Pregnant women&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sarah Pirio Richardson, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of New Mexico</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Davin Quinn, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of New Mexico</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of New Mexico</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>September 21, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 6, 2017</study_first_posted>
  <results_first_submitted>May 19, 2022</results_first_submitted>
  <results_first_submitted_qc>August 23, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">August 25, 2023</results_first_posted>
  <last_update_submitted>August 23, 2023</last_update_submitted>
  <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of New Mexico</investigator_affiliation>
    <investigator_full_name>Sarah Pirio Richardson</investigator_full_name>
    <investigator_title>Assistant Professor of Neurology</investigator_title>
  </responsible_party>
  <keyword>Metaplasticity</keyword>
  <keyword>Motor excitability</keyword>
  <keyword>rTMS</keyword>
  <keyword>tDCS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypersensitivity</mesh_term>
  </condition_browse>
  <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>December 16, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/62/NCT03304262/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 16, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/62/NCT03304262/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>This was a crossover design, in which each participant came in three times and was randomly assigned to each intervention with a wash-out period in between.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Cathodal tDCS + rTMS Then Anodal tDCS + rTMS Then Sham tDCS + rTMS</title>
          <description>Participant will receive 10 minutes of cathodal tDCS between M1 and M2 timepoints, and rTMS for 900 1Hz pulses at 0.85 of Resting Motor Threshold at M2. After 1 week washout, participant will receive 10 minutes of anodal tDCS between M1 and M2 timepoints, and rTMS for 900 1 Hz pulses at 0.85 Resting Motor Threshold at M2. After 1 week washout, participant will receive 10 minutes of sham tDCS between M1 and M2 timepoints, and rTMS for 900 1 Hz pulses at 0.85 Resting Motor Threshold at M2.&#xD;
rTMS: Between time point M2 and M3, participant will receive 900 pulses of rTMS at 1Hz at 0.85 of M2 resting motor threshold.</description>
        </group>
        <group group_id="P2">
          <title>Anodal tDCS + rTMS Then Sham tDCS + rTMS Then Cathodal tDCS + rTMS</title>
          <description>Participant will receive 10 minutes of anodal tDCS between M1 and M2 timepoints, and rTMS for 900 1Hz pulses at 0.85 of Resting Motor Threshold at M2. After 1 week washout, participant will receive 10 minutes of sham tDCS between M1 and M2 timepoints, and rTMS for 900 1 Hz pulses at 0.85 Resting Motor Threshold at M2. After 1 week washout, participant will receive 10 minutes of cathodal tDCS between M1 and M2 timepoints, and rTMS for 900 1 Hz pulses at 0.85 Resting Motor Threshold at M2.&#xD;
rTMS: Between time point M2 and M3, participant will receive 900 pulses of rTMS at 1Hz at 0.85 of M2 resting motor threshold.</description>
        </group>
        <group group_id="P3">
          <title>Sham tDCS + rTMS Then Cathodal tDCS + rTMS Then Anodal tDCS + rTMS</title>
          <description>Participant will receive 10 minutes of sham tDCS between M1 and M2 timepoints, and rTMS for 900 1Hz pulses at 0.85 of Resting Motor Threshold at M2. After 1 week washout, participant will receive 10 minutes of cathodal tDCS between M1 and M2 timepoints, and rTMS for 900 1 Hz pulses at 0.85 Resting Motor Threshold at M2. After 1 week washout, participant will receive 10 minutes of anodal tDCS between M1 and M2 timepoints, and rTMS for 900 1 Hz pulses at 0.85 Resting Motor Threshold at M2.&#xD;
rTMS: Between time point M2 and M3, participant will receive 900 pulses of rTMS at 1Hz at 0.85 of M2 resting motor threshold.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Cathodal tDCS + rTMS Then Anodal tDCS + rTMS Then Sham tDCS + rTMS</title>
          <description>Participant will receive 10 minutes of cathodal tDCS between M1 and M2 timepoints, and rTMS for 900 1Hz pulses at 0.85 of Resting Motor Threshold at M2. After 1 week washout, participant will receive 10 minutes of anodal tDCS between M1 and M2 timepoints, and rTMS for 900 1 Hz pulses at 0.85 Resting Motor Threshold at M2. After 1 week washout, participant will receive 10 minutes of sham tDCS between M1 and M2 timepoints, and rTMS for 900 1 Hz pulses at 0.85 Resting Motor Threshold at M2.&#xD;
rTMS: Between time point M2 and M3, participant will receive 900 pulses of rTMS at 1Hz at 0.85 of M2 resting motor threshold.</description>
        </group>
        <group group_id="B2">
          <title>Anodal tDCS + rTMS Then Sham tDCS + rTMS Then Cathodal tDCS + rTMS</title>
          <description>Participant will receive 10 minutes of anodal tDCS between M1 and M2 timepoints, and rTMS for 900 1Hz pulses at 0.85 of Resting Motor Threshold at M2. After 1 week washout, participant will receive 10 minutes of sham tDCS between M1 and M2 timepoints, and rTMS for 900 1 Hz pulses at 0.85 Resting Motor Threshold at M2. After 1 week washout, participant will receive 10 minutes of cathodal tDCS between M1 and M2 timepoints, and rTMS for 900 1 Hz pulses at 0.85 Resting Motor Threshold at M2.&#xD;
rTMS: Between time point M2 and M3, participant will receive 900 pulses of rTMS at 1Hz at 0.85 of M2 resting motor threshold.</description>
        </group>
        <group group_id="B3">
          <title>Sham tDCS + rTMS Then Cathodal tDCS + rTMS Then Anodal tDCS + rTMS</title>
          <description>Participant will receive 10 minutes of sham tDCS between M1 and M2 timepoints, and rTMS for 900 1Hz pulses at 0.85 of Resting Motor Threshold at M2. After 1 week washout, participant will receive 10 minutes of cathodal tDCS between M1 and M2 timepoints, and rTMS for 900 1 Hz pulses at 0.85 Resting Motor Threshold at M2. After 1 week washout, participant will receive 10 minutes of anodal tDCS between M1 and M2 timepoints, and rTMS for 900 1 Hz pulses at 0.85 Resting Motor Threshold at M2.&#xD;
rTMS: Between time point M2 and M3, participant will receive 900 pulses of rTMS at 1Hz at 0.85 of M2 resting motor threshold.</description>
        </group>
        <group group_id="B4">
          <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="4"/>
            <count group_id="B2" value="5"/>
            <count group_id="B3" value="4"/>
            <count group_id="B4" value="13"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35.54" lower_limit="23" upper_limit="52"/>
                    <measurement group_id="B2" value="35.54" lower_limit="28" upper_limit="46"/>
                    <measurement group_id="B3" value="35.54" lower_limit="25" upper_limit="36"/>
                    <measurement group_id="B4" value="35.54" lower_limit="23" upper_limit="52"/>
                  </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>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="5"/>
                  </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>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="5"/>
                  </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 group_id="B4" 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>
              <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="1"/>
                    <measurement group_id="B4" value="1"/>
                  </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="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                  </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 group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percent Change in MEP Amplitude</title>
        <description>Percent Change in MEP amplitude over the first dorsal interosseous (FDI) muscle of the right hand</description>
        <time_frame>assessed and reported throughout study completion pre- and post- intervention approximately 30 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cathodal tDCS + rTMS</title>
            <description>Participant will receive 10 minutes of cathodal tDCS between M1 and M2 timepoints, and rTMS for 900 1Hz pulses at 0.85 of Resting Motor Threshold at M2.&#xD;
rTMS: Between time point M2 and M3, participant will receive 900 pulses of rTMS at 1Hz at 0.85 of M2 resting motor threshold.</description>
          </group>
          <group group_id="O2">
            <title>Anodal tDCS + rTMS</title>
            <description>Participant will receive 10 minutes of anodal tDCS between M1 and M2 timepoints, and rTMS for 900 1Hz pulses at 0.85 of Resting Motor Threshold at M2.&#xD;
rTMS: Between time point M2 and M3, participant will receive 900 pulses of rTMS at 1Hz at 0.85 of M2 resting motor threshold.</description>
          </group>
          <group group_id="O3">
            <title>Sham tDCS + rTMS</title>
            <description>Participant will receive 10 minutes of sham tDCS between M1 and M2 timepoints, and rTMS for 900 1Hz pulses at 0.85 of Resting Motor Threshold at M2.&#xD;
rTMS: Between time point M2 and M3, participant will receive 900 pulses of rTMS at 1Hz at 0.85 of M2 resting motor threshold.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change in MEP Amplitude</title>
          <description>Percent Change in MEP amplitude over the first dorsal interosseous (FDI) muscle of the right hand</description>
          <units>Percent Change</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
                <count group_id="O3" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.19" lower_limit="0.43" upper_limit="5.65"/>
                    <measurement group_id="O2" value="1.06" lower_limit="0.33" upper_limit="2.03"/>
                    <measurement group_id="O3" value="1.38" lower_limit="0.19" upper_limit="2.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cortical Silent Period</title>
        <description>Change in length of CSP</description>
        <time_frame>tDCS + rTMS assessed and reported pre and post (approximately 10 minutes)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cathodal tDCS + rTMS</title>
            <description>Participant will receive 10 minutes of cathodal tDCS between M1 and M2 timepoints, and rTMS for 900 1Hz pulses at 0.85 of Resting Motor Threshold at M2.&#xD;
rTMS: Between time point M2 and M3, participant will receive 900 pulses of rTMS at 1Hz at 0.85 of M2 resting motor threshold.</description>
          </group>
          <group group_id="O2">
            <title>Anodal tDCS + rTMS</title>
            <description>Participant will receive 10 minutes of anodal tDCS between M1 and M2 timepoints, and rTMS for 900 1Hz pulses at 0.85 of Resting Motor Threshold at M2.&#xD;
rTMS: Between time point M2 and M3, participant will receive 900 pulses of rTMS at 1Hz at 0.85 of M2 resting motor threshold.</description>
          </group>
          <group group_id="O3">
            <title>Sham tDCS + rTMS</title>
            <description>Participant will receive 10 minutes of sham tDCS between M1 and M2 timepoints, and rTMS for 900 1Hz pulses at 0.85 of Resting Motor Threshold at M2.&#xD;
rTMS: Between time point M2 and M3, participant will receive 900 pulses of rTMS at 1Hz at 0.85 of M2 resting motor threshold.</description>
          </group>
        </group_list>
        <measure>
          <title>Cortical Silent Period</title>
          <description>Change in length of CSP</description>
          <units>Percent change</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
                <count group_id="O3" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.02" lower_limit="0.88" upper_limit="1.23"/>
                    <measurement group_id="O2" value="1.01" lower_limit="0.88" upper_limit="1.13"/>
                    <measurement group_id="O3" value="0.99" lower_limit=".88" upper_limit="1.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Simple Reaction Time</title>
        <description>Participants will perform a simple reaction time task. This will be measured in seconds of response after a stimulus. The final outcome will be percent change in the reaction time from pre- to post- intervention.</description>
        <time_frame>The final outcome will be percent change in the reaction time from pre- to post- intervention.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cathodal tDCS + rTMS</title>
            <description>Participant will receive 10 minutes of cathodal tDCS between M1 and M2 timepoints, and rTMS for 900 1Hz pulses at 0.85 of Resting Motor Threshold at M2.&#xD;
rTMS: Between time point M2 and M3, participant will receive 900 pulses of rTMS at 1Hz at 0.85 of M2 resting motor threshold.</description>
          </group>
          <group group_id="O2">
            <title>Anodal tDCS + rTMS</title>
            <description>Participant will receive 10 minutes of anodal tDCS between M1 and M2 timepoints, and rTMS for 900 1Hz pulses at 0.85 of Resting Motor Threshold at M2.&#xD;
rTMS: Between time point M2 and M3, participant will receive 900 pulses of rTMS at 1Hz at 0.85 of M2 resting motor threshold.</description>
          </group>
          <group group_id="O3">
            <title>Sham tDCS + rTMS</title>
            <description>Participant will receive 10 minutes of sham tDCS between M1 and M2 timepoints, and rTMS for 900 1Hz pulses at 0.85 of Resting Motor Threshold at M2.&#xD;
rTMS: Between time point M2 and M3, participant will receive 900 pulses of rTMS at 1Hz at 0.85 of M2 resting motor threshold.</description>
          </group>
        </group_list>
        <measure>
          <title>Simple Reaction Time</title>
          <description>Participants will perform a simple reaction time task. This will be measured in seconds of response after a stimulus. The final outcome will be percent change in the reaction time from pre- to post- intervention.</description>
          <units>Percent change</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
                <count group_id="O3" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.01" lower_limit="0.94" upper_limit="1.15"/>
                    <measurement group_id="O2" value="1.02" lower_limit="0.91" upper_limit="1.19"/>
                    <measurement group_id="O3" value="1.02" lower_limit="0.9" upper_limit="1.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>3 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Cathodal tDCS + rTMS</title>
          <description>Participant will receive 10 minutes of cathodal tDCS between M1 and M2 timepoints, and rTMS for 900 1Hz pulses at 0.85 of Resting Motor Threshold at M2.&#xD;
rTMS: Between time point M2 and M3, participant will receive 900 pulses of rTMS at 1Hz at 0.85 of M2 resting motor threshold.</description>
        </group>
        <group group_id="E2">
          <title>Anodal tDCS + rTMS</title>
          <description>Participant will receive 10 minutes of anodal tDCS between M1 and M2 timepoints, and rTMS for 900 1Hz pulses at 0.85 of Resting Motor Threshold at M2.&#xD;
rTMS: Between time point M2 and M3, participant will receive 900 pulses of rTMS at 1Hz at 0.85 of M2 resting motor threshold.</description>
        </group>
        <group group_id="E3">
          <title>Sham tDCS + rTMS</title>
          <description>Participant will receive 10 minutes of sham tDCS between M1 and M2 timepoints, and rTMS for 900 1Hz pulses at 0.85 of Resting Motor Threshold at M2.&#xD;
rTMS: Between time point M2 and M3, participant will receive 900 pulses of rTMS at 1Hz at 0.85 of M2 resting motor threshold.</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="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
              </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>Sarah Pirio Richardson</name_or_title>
      <organization>University of New Mexico</organization>
      <phone>505-272-3342</phone>
      <email>spiriorichardson@salud.unm.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/NCT03304262
org study id: 16-410
nct id: NCT03304262
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
The overall objective is to validate the methodology of a metaplasticity experimental design
      by assessing change in motor excitability after administration of priming transcranial direct
      current stimulation (tDCS) followed by repetitive transcranial magnetic stimulation (rTMS) in
      healthy human participants.
The overall objective is to validate the methodology of a metaplasticity experimental design
      by assessing change in motor excitability after administration of priming transcranial direct
      current stimulation (tDCS) followed by repetitive transcranial magnetic stimulation (rTMS) in
      healthy human participants. Our primary objective is to compare pre- and post-measures of
      cortical excitability before priming tDCS (anodal, cathodal or sham) [M1], directly after
      priming tDCS [M2], directly after inhibitory rTMS [M3], and 10 minutes after inhibitory rTMS
      [M4]. Our secondary objective is to evaluate the sensitivity of motor excitability outcome
      measures response to the noninvasive neurostimulation (e.g. rTMS and tDCS). We also aim to
      compare pre- and post- measures of cortical excitability after inhibitory and excitatory
      priming of the motor cortex, and to evaluate the sensitivity of motor outcome measures to
      changes in cortical plasticity.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: This is a randomized, sham-controlled, double blinded crossover trial.
primary purpose: Diagnostic
masking: Double (Participant, Investigator)
masking description: Participants will be blinded to treatment group, investigator administering tDCS will be blinded to which treatment arm subject is assigned to, and the data analyst will be conducting analysis off site and is different than investigator applying stimulation.
measure: Percent Change in MEP Amplitude
time frame: assessed and reported throughout study completion pre- and post- intervention approximately 30 minutes
description: Percent Change in MEP amplitude over the first dorsal interosseous (FDI) muscle of the right hand
measure: Cortical Silent Period
time frame: tDCS + rTMS assessed and reported pre and post (approximately 10 minutes)
description: Change in length of CSP
measure: Simple Reaction Time
time frame: The final outcome will be percent change in the reaction time from pre- to post- intervention.
description: Participants will perform a simple reaction time task. This will be measured in seconds of response after a stimulus. The final outcome will be percent change in the reaction time from pre- to post- intervention.
arm group label: Cathodal tDCS + rTMS then Anodal tDCS + rTMS then Sham tDCS + rTMS
arm group type: Active Comparator
description: Participant will receive 10 minutes of cathodal tDCS between M1 and M2 timepoints, and rTMS for 900 1Hz pulses at 0.85 of Resting Motor Threshold at M2. After 1 week washout, participant will receive 10 minutes of anodal tDCS and rTMS for 900 1Hz pulses at 0.85 RMT. After 1 week washout, participant will receive 10 minutes of sham tDCS and rTMS for 900 1 Hz pulses at 0.85 RMT.
arm group label: Anodal tDCS + rTMS then Sham tDCS + rTMS then Cathodal tDCS + rTMS
arm group type: Active Comparator
description: Participant will receive 10 minutes of anodal tDCS between M1 and M2 timepoints, and rTMS for 900 1Hz pulses at 0.85 of Resting Motor Threshold at M2. After 1 week washout, participant will receive 10 minutes of sham tDCS and rTMS for 900 1 Hz pulses at 0.85 RMT. After 1 week washout, participant will receive 10 minutes of cathodal tDCS and rTMS for 900 1 Hz pulses at 0.85 RMT.
arm group label: Sham tDCS + rTMS then Cathodal tDCS + rTMS then Anodal tDCS + rTMS
arm group type: Sham Comparator
description: Participant will receive 10 minutes of sham tDCS between M1 and M2 timepoints, and rTMS for 900 1Hz pulses at 0.85 of Resting Motor Threshold at M2. After 1 week washout, participant will receive 10 minutes of cathodal tDCS and rTMS for 900 1 Hz pulses at 0.85 RMT. After 1 week washout, participant will receive 10 minutes of anodal tDCS and rTMS for 900 1 Hz pulses at 0.85 RMT.
intervention type: Device
intervention name: rTMS
description: Between time point M2 and M3, participant will receive 900 pulses of rTMS at 1Hz at 0.85 of M2 resting motor threshold.
arm group label: Anodal tDCS + rTMS then Sham tDCS + rTMS then Cathodal tDCS + rTMS
arm group label: Cathodal tDCS + rTMS then Anodal tDCS + rTMS then Sham tDCS + rTMS
arm group label: Sham tDCS + rTMS then Cathodal tDCS + rTMS then Anodal tDCS + rTMS
other name: rapid transcranial magnetic stimulation
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sarah Pirio Richardson, M.D.
role: Principal Investigator
affiliation: University of New Mexico
last name: Davin Quinn, M.D.
role: Principal Investigator
affiliation: University of New Mexico
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of New Mexico
investigator full name: Sarah Pirio Richardson
investigator title: Assistant Professor of Neurology
mesh term: Hypersensitivity
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 