<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/NCT01709383</url>
  </required_header>
  <id_info>
    <org_study_id>DDCF 2012062</org_study_id>
    <nct_id>NCT01709383</nct_id>
  </id_info>
  <brief_title>Using Transcranial Direct Current Stimulation (tDCS) to Improve Post-Stroke Aphasia</brief_title>
  <official_title>Can Enhancing Left Lateralization Using Transcranial Direct Current Stimulation Improve Recovery From Post-Stroke Aphasia?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Georgetown University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medstar Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Georgetown University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study tests whether weak electrical stimulation of the brain is effective in improving&#xD;
      language or reading difficulties occurring after a brain injury or stroke.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study tests whether aphasia or alexia, language and reading disorders occurring after&#xD;
      traumatic brain injury or stroke, can be improved using transcranial direct current&#xD;
      stimulation (tDCS). tDCS is a non-invasive technique that applies a small amount of direct&#xD;
      electrical current to the brain in order to temporarily alter brain processing. Adults with&#xD;
      aphasia/alexia resulting from stroke or traumatic brain injury will undergo baseline&#xD;
      behavioral testing of various language and cognitive functions. Subjects who are willing to&#xD;
      undergo MRI evaluation will also be scanned. They will then receive five days of either real&#xD;
      or sham tDCS with standardized speech-language therapy, under a double-blind randomized&#xD;
      placebo-controlled design. Behavioral assessments, and MRIs for those participating in the&#xD;
      MRI portion of the study, will be performed again at multiple time points after completing&#xD;
      tDCS to assess for changes in these measures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Western Aphasia Battery - Revised: Naming and Word Finding Score</measure>
    <time_frame>Change from baseline to one day after treatment</time_frame>
    <description>This is a composite measure of verbal expression skills including tests of naming, verbal fluency, sentence completion, and responsive naming (one-word answers to basic questions). It is a subtest within the Western Aphasia Battery. The minimum score is 0 and maximum is 10, with 10 being the best outcome, and subscores are summed to determine the total score.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Western Aphasia Battery - Revised: Spontaneous Speech, Repetition, Auditory Verbal Comprehension and Overall Aphasia Quotient</measure>
    <time_frame>Change from baseline to 1 day after treatment</time_frame>
    <description>The above subtests will reflect the following: a composite measure of information content in conversational speech and picture description (scored from 0 (no speech produced or only meaningless utterances) to 10 (no signs of aphasia)); a measure of word and sentence repetition (scored from 0 (unable to repeat any part of a single word) to 100 (perfect repetition of all words and up to a 10 word sentence)); a composite measure of yes/no questions, auditory word recognition, and following sequential commands (composite subscore is from 1 to 10, with 10 being the best outcome); and an overall aphasia severity score (composite score, or Aphasia Quotient, comprised of all the above measures plus the naming and word finding score used as the primary outcome measure. Quotient scores range from 0 to 100, with 100 indicating no aphasia is present).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Philadelphia Naming Test (PNT)</measure>
    <time_frame>1 day after treatment</time_frame>
    <description>A test of picture naming using more common items than other picture naming tests, which reduces relationships between performance and premorbid education and socioeconomic status. There are 60 items on the test. A score of 0 means no pictures were named correctly. A score of 60 means all pictures were named correctly.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective Assessments Including: Communicative Effectiveness Index (CETI), Stroke and Aphasia Quality of Life Scale (SAQOL), and Stroke Aphasic Depression Questionnaire (SADQ)</measure>
    <time_frame>3 weeks post-treatment</time_frame>
    <description>Questionnaires were given at baseline, 3 weeks and 3 months after treatment. The SADQ consists of 21 questions graded on a 0-3 scale with 3 indicating the highest depression symptoms and 0 indicating none. Therefore, means reported below are an average score between 0 and 3. The SAQOL includes 17 questions about functional physical limitations and 7 questions about functional communication limitations in daily life. Questions are rated on a 1-5 scale with a score of 1 indicating greater disability and 5 indicating none. Therefore, means reported below are an average score between 1 and 5. The CETI measures change in functional communication by asking caregivers to make a mark on a straight line with &quot;as able as before the stroke&quot; written on the right side of the line and &quot;not at all as able&quot; on the left. The 16 responses are then converted by measuring the location of the mark on the line. A score of 10 indicates &quot;as able as before the stroke&quot; and 0 indicates &quot;not at all as able&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive-Linguistic Quick Test (CLQT)</measure>
    <time_frame>Change from baseline to 1 day after treatment</time_frame>
    <description>The following subtests from the CLQT will be administered: Symbol Cancellation, Story Retelling, Generative Naming, Symbol Trails, Design Memory, Mazes,and Design Generation. These scores will be used to calculate composite scores for the cognitive domains of Attention, Executive Function (EF), and Visuospatial skills (VS). Some tests are weighted more than others in each composite score, by multiplying the score as follows and then adding the scores together: Attention = Symbol Cancellation (x9), Story Retelling (x2), Symbol Trails (x3), Mazes (x4), and Design Generation (x1); EF = sum of Symbol Trails, Generative Naming, Mazes, and Design Generation; VS = Symbol Cancellation (x2), Symbol Trails (x2), Design Memory (x4), Mazes (x3), Design Generation (x1). For all composite scores, a low number indicates greater deficit. For Attention, the highest score is 215 and lowest is 0. For EF, the highest score is 40 and lowest is 0. For VS, the highest score is 105 and lowest is 0</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reading Assessments</measure>
    <time_frame>Change from baseline to 1 day after treatment</time_frame>
    <description>A set of reading tasks designed to assess oral reading of real words and non-words at the single word level. The list of real words consisted of 142 words. A score of 0 indicates no words were read correctly and a score of 142 indicates all words were read correctly. The non-word test included 30 non-words. A score of 0 indicates no non-words were read correctly and a score of 30 indicates that all non-words were read correctly.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motricity Index</measure>
    <time_frame>Change from baseline to 1 day after treatment</time_frame>
    <description>An assessment of upper extremity motor impairment, including: pinch grip, elbow flexion, and shoulder abduction. For pinch grip, which consisted of holding a small plastic cube between the thumb and index finger, scoring was as follows: 0=No movement, 11=Beginnings of prehension, 19=Grips cube but unable to hold against gravity, 22=Grips cube, held against gravity but not against weak pull, 26=Grips cube against pull but weaker than left side, 33=Normal pinch grip. For elbow flexion and shoulder abduction, scoring was as follows: 0=No movement, 9=Palpable contraction in muscle but no movement, 14=Movement seen but not full range/not against gravity, 19=Full range against gravity, not against resistance, 25=Movement against resistance but weaker than left side, 33=Normal power. Both the right and the left side were tested.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Aphasia</condition>
  <arm_group>
    <arm_group_label>Transcranial Direct Current Stimulation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>TDCS was applied bilaterally, with the anodal electrode on the left temple and cathodal electrode on the right. TDCS was applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham Stimulation</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Sham tDCS was applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Transcranial Direct Current Stimulation</intervention_name>
    <description>The tDCS treatments will be applied bilaterally, with the anodal electrode placed on the left temple and the cathodal electrode placed on the right temple. The tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.</description>
    <arm_group_label>Transcranial Direct Current Stimulation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham Stimulation</intervention_name>
    <description>The sham tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.</description>
    <arm_group_label>Sham Stimulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 or older&#xD;
&#xD;
          -  Aphasia due to left hemisphere stroke diagnosed by a physician or speech-language&#xD;
             pathologist&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Skull defect at or near the site of tDCS delivery&#xD;
&#xD;
          -  History of a significant stroke or traumatic brain injury other than the event that&#xD;
             caused the aphasia&#xD;
&#xD;
          -  History of other brain conditions that could impact interpretation of results (such as&#xD;
             multiple sclerosis, brain tumor, encephalitis, premorbid dementia)&#xD;
&#xD;
          -  Presence of implanted electrical or metallic devices in the head or body (except&#xD;
             titanium; e.g. cochlear implants, implanted shunts with metal parts, deep brain&#xD;
             stimulators, pacemakers, defibrillators)&#xD;
&#xD;
          -  Presence of ferrous metal in the head (e.g. shrapnel)&#xD;
&#xD;
          -  History of psychiatric disease requiring hospitalization, electroconvulsive therapy,&#xD;
             or ongoing medication use (other than common selective serotonin reuptake inhibitor&#xD;
             antidepressants)&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Severe comprehension deficits&#xD;
&#xD;
        Additional Exclusion Criteria for the optional MRI portion of the study:&#xD;
&#xD;
          -  Presence of metal in the body (except titanium)&#xD;
&#xD;
          -  Claustrophobia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter Turkeltaub, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Georgetown University and MedStar National Rehabilitation Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>MedStar National Rehabilitation Hospital</name>
      <address>
        <city>Washington, D.C.</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Georgetown University</name>
      <address>
        <city>Washington, D.C.</city>
        <state>District of Columbia</state>
        <zip>20057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Zaghi S, Acar M, Hultgren B, Boggio PS, Fregni F. Noninvasive brain stimulation with low-intensity electrical currents: putative mechanisms of action for direct and alternating current stimulation. Neuroscientist. 2010 Jun;16(3):285-307. doi: 10.1177/1073858409336227. Epub 2009 Dec 29.</citation>
    <PMID>20040569</PMID>
  </results_reference>
  <results_reference>
    <citation>Schlaug G, Marchina S, Wan CY. The use of non-invasive brain stimulation techniques to facilitate recovery from post-stroke aphasia. Neuropsychol Rev. 2011 Sep;21(3):288-301. doi: 10.1007/s11065-011-9181-y. Epub 2011 Aug 14.</citation>
    <PMID>21842404</PMID>
  </results_reference>
  <results_reference>
    <citation>Fridriksson J, Richardson JD, Baker JM, Rorden C. Transcranial direct current stimulation improves naming reaction time in fluent aphasia: a double-blind, sham-controlled study. Stroke. 2011 Mar;42(3):819-21. doi: 10.1161/STROKEAHA.110.600288. Epub 2011 Jan 13.</citation>
    <PMID>21233468</PMID>
  </results_reference>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>August 28, 2012</study_first_submitted>
  <study_first_submitted_qc>October 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 18, 2012</study_first_posted>
  <results_first_submitted>October 27, 2016</results_first_submitted>
  <results_first_submitted_qc>June 6, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">July 6, 2017</results_first_posted>
  <last_update_submitted>June 6, 2017</last_update_submitted>
  <last_update_submitted_qc>June 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Aphasia</keyword>
  <keyword>Stroke</keyword>
  <keyword>Transcranial Direct Current Stimulation</keyword>
  <keyword>Neuroplasticity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aphasia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Inclusionary criteria were as follows: over 18; aphasia due to left hemisphere stroke; no other significant brain damage, neurological, or psychiatric disease; no skull defects near electrode sites; no implanted devices or ferrous metal in the body; not pregnant; comprehension sufficient to perform study tasks</recruitment_details>
      <pre_assignment_details>Before randomization, potential subjects were tested on the Western Aphasia Battery -Revised (WAB-R) to determine a baseline score and to rule out severe comprehension deficits.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Transcranial Direct Current Stimulation</title>
          <description>Transcranial Direct Current Stimulation: The tDCS treatments will be applied bilaterally, with the anodal electrode placed on the left temple and the cathodal electrode placed on the right temple. The tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.</description>
        </group>
        <group group_id="P2">
          <title>Sham Stimulation</title>
          <description>Sham Stimulation: The sham tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed Treatment</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed Follow-ups</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Included in Analysis</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="14"/>
              </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>Lost to Follow-up</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>People with aphasia due to left hemisphere stroke</population>
      <group_list>
        <group group_id="B1">
          <title>Transcranial Direct Current Stimulation</title>
          <description>Transcranial Direct Current Stimulation: The tDCS treatments will be applied bilaterally, with the anodal electrode placed on the left temple and the cathodal electrode placed on the right temple. The tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.</description>
        </group>
        <group group_id="B2">
          <title>Sham Stimulation</title>
          <description>Sham Stimulation: The sham tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.</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="24"/>
            <count group_id="B2" value="14"/>
            <count group_id="B3" value="38"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60.0" spread="10.8"/>
                    <measurement group_id="B2" value="59.8" spread="8.7"/>
                    <measurement group_id="B3" value="60.0" spread="10.0"/>
                  </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="8"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="25"/>
                  </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="24"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Western Aphasia Battery - Revised: Naming and Word Finding Score</title>
        <description>This is a composite measure of verbal expression skills including tests of naming, verbal fluency, sentence completion, and responsive naming (one-word answers to basic questions). It is a subtest within the Western Aphasia Battery. The minimum score is 0 and maximum is 10, with 10 being the best outcome, and subscores are summed to determine the total score.</description>
        <time_frame>Change from baseline to one day after treatment</time_frame>
        <population>People with aphasia due to left hemisphere stroke</population>
        <group_list>
          <group group_id="O1">
            <title>Transcranial Direct Current Stimulation</title>
            <description>Transcranial Direct Current Stimulation: The tDCS treatments will be applied bilaterally, with the anodal electrode placed on the left temple and the cathodal electrode placed on the right temple. The tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.</description>
          </group>
          <group group_id="O2">
            <title>Sham Stimulation</title>
            <description>Sham Stimulation: The sham tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.</description>
          </group>
        </group_list>
        <measure>
          <title>Western Aphasia Battery - Revised: Naming and Word Finding Score</title>
          <description>This is a composite measure of verbal expression skills including tests of naming, verbal fluency, sentence completion, and responsive naming (one-word answers to basic questions). It is a subtest within the Western Aphasia Battery. The minimum score is 0 and maximum is 10, with 10 being the best outcome, and subscores are summed to determine the total score.</description>
          <population>People with aphasia due to left hemisphere stroke</population>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".30" spread=".64"/>
                    <measurement group_id="O2" value=".48" spread=".74"/>
                  </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>Superiority or Other</non_inferiority_type>
            <p_value>.57</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Western Aphasia Battery - Revised: Spontaneous Speech, Repetition, Auditory Verbal Comprehension and Overall Aphasia Quotient</title>
        <description>The above subtests will reflect the following: a composite measure of information content in conversational speech and picture description (scored from 0 (no speech produced or only meaningless utterances) to 10 (no signs of aphasia)); a measure of word and sentence repetition (scored from 0 (unable to repeat any part of a single word) to 100 (perfect repetition of all words and up to a 10 word sentence)); a composite measure of yes/no questions, auditory word recognition, and following sequential commands (composite subscore is from 1 to 10, with 10 being the best outcome); and an overall aphasia severity score (composite score, or Aphasia Quotient, comprised of all the above measures plus the naming and word finding score used as the primary outcome measure. Quotient scores range from 0 to 100, with 100 indicating no aphasia is present).</description>
        <time_frame>Change from baseline to 1 day after treatment</time_frame>
        <population>People with aphasia due to left hemisphere stroke</population>
        <group_list>
          <group group_id="O1">
            <title>Transcranial Direct Current Stimulation</title>
            <description>Transcranial Direct Current Stimulation: The tDCS treatments will be applied bilaterally, with the anodal electrode placed on the left temple and the cathodal electrode placed on the right temple. The tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.</description>
          </group>
          <group group_id="O2">
            <title>Sham Stimulation</title>
            <description>Sham Stimulation: The sham tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.</description>
          </group>
        </group_list>
        <measure>
          <title>Western Aphasia Battery - Revised: Spontaneous Speech, Repetition, Auditory Verbal Comprehension and Overall Aphasia Quotient</title>
          <description>The above subtests will reflect the following: a composite measure of information content in conversational speech and picture description (scored from 0 (no speech produced or only meaningless utterances) to 10 (no signs of aphasia)); a measure of word and sentence repetition (scored from 0 (unable to repeat any part of a single word) to 100 (perfect repetition of all words and up to a 10 word sentence)); a composite measure of yes/no questions, auditory word recognition, and following sequential commands (composite subscore is from 1 to 10, with 10 being the best outcome); and an overall aphasia severity score (composite score, or Aphasia Quotient, comprised of all the above measures plus the naming and word finding score used as the primary outcome measure. Quotient scores range from 0 to 100, with 100 indicating no aphasia is present).</description>
          <population>People with aphasia due to left hemisphere stroke</population>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Spontaneous Speech Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.6" spread="2.0"/>
                    <measurement group_id="O2" value="7.1" spread="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spontaneous Speech 1 day post-treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.8" spread="2.4"/>
                    <measurement group_id="O2" value="7.0" spread="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Repetition Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.5" spread="2.9"/>
                    <measurement group_id="O2" value="6.2" spread="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Repetition 1 Day post-treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.8" spread="2.8"/>
                    <measurement group_id="O2" value="6.2" spread="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Auditory Verbal Comprehension Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.9" spread="1.3"/>
                    <measurement group_id="O2" value="8.0" spread="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Auditory Verbal Comprehension 1 day post</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.1" spread="1.4"/>
                    <measurement group_id="O2" value="7.8" spread="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Aphasia Quotient Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.2" spread="21.7"/>
                    <measurement group_id="O2" value="61.9" spread="28.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Aphasia Quotient 1 Day post-treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.2" spread="21.7"/>
                    <measurement group_id="O2" value="65.1" spread="26.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Philadelphia Naming Test (PNT)</title>
        <description>A test of picture naming using more common items than other picture naming tests, which reduces relationships between performance and premorbid education and socioeconomic status. There are 60 items on the test. A score of 0 means no pictures were named correctly. A score of 60 means all pictures were named correctly.</description>
        <time_frame>1 day after treatment</time_frame>
        <population>People with aphasia due to left hemisphere stroke</population>
        <group_list>
          <group group_id="O1">
            <title>Transcranial Direct Current Stimulation</title>
            <description>TDCS was applied bilaterally, with the anodal electrode on the left temple and cathodal electrode on the right. TDCS was applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period&#xD;
Transcranial Direct Current Stimulation: The tDCS treatments will be applied bilaterally, with the anodal electrode placed on the left temple and the cathodal electrode placed on the right temple. The tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.</description>
          </group>
          <group group_id="O2">
            <title>Sham Stimulation</title>
            <description>Sham tDCS was applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.&#xD;
Sham Stimulation: The sham tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.</description>
          </group>
        </group_list>
        <measure>
          <title>Philadelphia Naming Test (PNT)</title>
          <description>A test of picture naming using more common items than other picture naming tests, which reduces relationships between performance and premorbid education and socioeconomic status. There are 60 items on the test. A score of 0 means no pictures were named correctly. A score of 60 means all pictures were named correctly.</description>
          <population>People with aphasia due to left hemisphere stroke</population>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PNT Score Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.3" spread="17.8"/>
                    <measurement group_id="O2" value="32.1" spread="23.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PNT Score 1 Day Post-treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.1" spread="21.1"/>
                    <measurement group_id="O2" value="34.9" spread="3.1"/>
                  </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>Superiority or Other</non_inferiority_type>
            <p_value>.64</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subjective Assessments Including: Communicative Effectiveness Index (CETI), Stroke and Aphasia Quality of Life Scale (SAQOL), and Stroke Aphasic Depression Questionnaire (SADQ)</title>
        <description>Questionnaires were given at baseline, 3 weeks and 3 months after treatment. The SADQ consists of 21 questions graded on a 0-3 scale with 3 indicating the highest depression symptoms and 0 indicating none. Therefore, means reported below are an average score between 0 and 3. The SAQOL includes 17 questions about functional physical limitations and 7 questions about functional communication limitations in daily life. Questions are rated on a 1-5 scale with a score of 1 indicating greater disability and 5 indicating none. Therefore, means reported below are an average score between 1 and 5. The CETI measures change in functional communication by asking caregivers to make a mark on a straight line with &quot;as able as before the stroke&quot; written on the right side of the line and &quot;not at all as able&quot; on the left. The 16 responses are then converted by measuring the location of the mark on the line. A score of 10 indicates &quot;as able as before the stroke&quot; and 0 indicates &quot;not at all as able&quot;.</description>
        <time_frame>3 weeks post-treatment</time_frame>
        <population>People with aphasia due to left hemisphere stroke</population>
        <group_list>
          <group group_id="O1">
            <title>Transcranial Direct Current Stimulation</title>
            <description>Transcranial Direct Current Stimulation: The tDCS treatments will be applied bilaterally, with the anodal electrode placed on the left temple and the cathodal electrode placed on the right temple. The tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.</description>
          </group>
          <group group_id="O2">
            <title>Sham Stimulation</title>
            <description>Sham Stimulation: The sham tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.</description>
          </group>
        </group_list>
        <measure>
          <title>Subjective Assessments Including: Communicative Effectiveness Index (CETI), Stroke and Aphasia Quality of Life Scale (SAQOL), and Stroke Aphasic Depression Questionnaire (SADQ)</title>
          <description>Questionnaires were given at baseline, 3 weeks and 3 months after treatment. The SADQ consists of 21 questions graded on a 0-3 scale with 3 indicating the highest depression symptoms and 0 indicating none. Therefore, means reported below are an average score between 0 and 3. The SAQOL includes 17 questions about functional physical limitations and 7 questions about functional communication limitations in daily life. Questions are rated on a 1-5 scale with a score of 1 indicating greater disability and 5 indicating none. Therefore, means reported below are an average score between 1 and 5. The CETI measures change in functional communication by asking caregivers to make a mark on a straight line with &quot;as able as before the stroke&quot; written on the right side of the line and &quot;not at all as able&quot; on the left. The 16 responses are then converted by measuring the location of the mark on the line. A score of 10 indicates &quot;as able as before the stroke&quot; and 0 indicates &quot;not at all as able&quot;.</description>
          <population>People with aphasia due to left hemisphere stroke</population>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SADQ Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" spread=".2"/>
                    <measurement group_id="O2" value="1.58" spread=".4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SADQ 3 weeks post-treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" spread=".3"/>
                    <measurement group_id="O2" value="1.3" spread=".4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAQOL Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7" spread=".7"/>
                    <measurement group_id="O2" value="2.6" spread=".7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAQOL 3 weeks post-treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9" spread=".8"/>
                    <measurement group_id="O2" value="2.7" spread=".9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CETI Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.7" spread="1.7"/>
                    <measurement group_id="O2" value="6.8" spread="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CETI 3 weeks post-treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.6" spread="2.0"/>
                    <measurement group_id="O2" value="6.4" spread="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cognitive-Linguistic Quick Test (CLQT)</title>
        <description>The following subtests from the CLQT will be administered: Symbol Cancellation, Story Retelling, Generative Naming, Symbol Trails, Design Memory, Mazes,and Design Generation. These scores will be used to calculate composite scores for the cognitive domains of Attention, Executive Function (EF), and Visuospatial skills (VS). Some tests are weighted more than others in each composite score, by multiplying the score as follows and then adding the scores together: Attention = Symbol Cancellation (x9), Story Retelling (x2), Symbol Trails (x3), Mazes (x4), and Design Generation (x1); EF = sum of Symbol Trails, Generative Naming, Mazes, and Design Generation; VS = Symbol Cancellation (x2), Symbol Trails (x2), Design Memory (x4), Mazes (x3), Design Generation (x1). For all composite scores, a low number indicates greater deficit. For Attention, the highest score is 215 and lowest is 0. For EF, the highest score is 40 and lowest is 0. For VS, the highest score is 105 and lowest is 0</description>
        <time_frame>Change from baseline to 1 day after treatment</time_frame>
        <population>People with aphasia due to left hemisphere stroke</population>
        <group_list>
          <group group_id="O1">
            <title>Transcranial Direct Current Stimulation</title>
            <description>Transcranial Direct Current Stimulation: The tDCS treatments will be applied bilaterally, with the anodal electrode placed on the left temple and the cathodal electrode placed on the right temple. The tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.</description>
          </group>
          <group group_id="O2">
            <title>Sham Stimulation</title>
            <description>Sham Stimulation: The sham tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.</description>
          </group>
        </group_list>
        <measure>
          <title>Cognitive-Linguistic Quick Test (CLQT)</title>
          <description>The following subtests from the CLQT will be administered: Symbol Cancellation, Story Retelling, Generative Naming, Symbol Trails, Design Memory, Mazes,and Design Generation. These scores will be used to calculate composite scores for the cognitive domains of Attention, Executive Function (EF), and Visuospatial skills (VS). Some tests are weighted more than others in each composite score, by multiplying the score as follows and then adding the scores together: Attention = Symbol Cancellation (x9), Story Retelling (x2), Symbol Trails (x3), Mazes (x4), and Design Generation (x1); EF = sum of Symbol Trails, Generative Naming, Mazes, and Design Generation; VS = Symbol Cancellation (x2), Symbol Trails (x2), Design Memory (x4), Mazes (x3), Design Generation (x1). For all composite scores, a low number indicates greater deficit. For Attention, the highest score is 215 and lowest is 0. For EF, the highest score is 40 and lowest is 0. For VS, the highest score is 105 and lowest is 0</description>
          <population>People with aphasia due to left hemisphere stroke</population>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Attention Composite Score Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="150.0" spread="46.4"/>
                    <measurement group_id="O2" value="175.5" spread="33.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Attention Composite Score 1 day post-treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="155.9" spread="50.3"/>
                    <measurement group_id="O2" value="184.9" spread="21.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Executive Function Composite Score Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.9" spread="6.5"/>
                    <measurement group_id="O2" value="23.7" spread="5.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Executive Function Composite Score 1 Day Post</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.1" spread="7.6"/>
                    <measurement group_id="O2" value="25.3" spread="5.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visuospatial Function Composite Score Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.6" spread="17.6"/>
                    <measurement group_id="O2" value="86.7" spread="12.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visuospatial Function Composite Score 1 Day Post</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80.7" spread="20.4"/>
                    <measurement group_id="O2" value="91.4" spread="12.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Reading Assessments</title>
        <description>A set of reading tasks designed to assess oral reading of real words and non-words at the single word level. The list of real words consisted of 142 words. A score of 0 indicates no words were read correctly and a score of 142 indicates all words were read correctly. The non-word test included 30 non-words. A score of 0 indicates no non-words were read correctly and a score of 30 indicates that all non-words were read correctly.</description>
        <time_frame>Change from baseline to 1 day after treatment</time_frame>
        <population>People with aphasia due to left hemisphere stroke</population>
        <group_list>
          <group group_id="O1">
            <title>Transcranial Direct Current Stimulation</title>
            <description>Transcranial Direct Current Stimulation: The tDCS treatments will be applied bilaterally, with the anodal electrode placed on the left temple and the cathodal electrode placed on the right temple. The tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.</description>
          </group>
          <group group_id="O2">
            <title>Sham Stimulation</title>
            <description>Sham Stimulation: The sham tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.</description>
          </group>
        </group_list>
        <measure>
          <title>Reading Assessments</title>
          <description>A set of reading tasks designed to assess oral reading of real words and non-words at the single word level. The list of real words consisted of 142 words. A score of 0 indicates no words were read correctly and a score of 142 indicates all words were read correctly. The non-word test included 30 non-words. A score of 0 indicates no non-words were read correctly and a score of 30 indicates that all non-words were read correctly.</description>
          <population>People with aphasia due to left hemisphere stroke</population>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Reading Real Words Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.1" spread="51.2"/>
                    <measurement group_id="O2" value="85.1" spread="61.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reading Real Words 1 Day Post-treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.7" spread="50.5"/>
                    <measurement group_id="O2" value="87.3" spread="59.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reading Non-words Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.1" spread="6.3"/>
                    <measurement group_id="O2" value="8.9" spread="8.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reading Non-words 1 Day Post-treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.3" spread="7.4"/>
                    <measurement group_id="O2" value="8.5" spread="8.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Motricity Index</title>
        <description>An assessment of upper extremity motor impairment, including: pinch grip, elbow flexion, and shoulder abduction. For pinch grip, which consisted of holding a small plastic cube between the thumb and index finger, scoring was as follows: 0=No movement, 11=Beginnings of prehension, 19=Grips cube but unable to hold against gravity, 22=Grips cube, held against gravity but not against weak pull, 26=Grips cube against pull but weaker than left side, 33=Normal pinch grip. For elbow flexion and shoulder abduction, scoring was as follows: 0=No movement, 9=Palpable contraction in muscle but no movement, 14=Movement seen but not full range/not against gravity, 19=Full range against gravity, not against resistance, 25=Movement against resistance but weaker than left side, 33=Normal power. Both the right and the left side were tested.</description>
        <time_frame>Change from baseline to 1 day after treatment</time_frame>
        <population>People with aphasia due to left hemisphere stroke</population>
        <group_list>
          <group group_id="O1">
            <title>Transcranial Direct Current Stimulation</title>
            <description>Transcranial Direct Current Stimulation: The tDCS treatments will be applied bilaterally, with the anodal electrode placed on the left temple and the cathodal electrode placed on the right temple. The tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.</description>
          </group>
          <group group_id="O2">
            <title>Sham Stimulation</title>
            <description>Sham Stimulation: The sham tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.</description>
          </group>
        </group_list>
        <measure>
          <title>Motricity Index</title>
          <description>An assessment of upper extremity motor impairment, including: pinch grip, elbow flexion, and shoulder abduction. For pinch grip, which consisted of holding a small plastic cube between the thumb and index finger, scoring was as follows: 0=No movement, 11=Beginnings of prehension, 19=Grips cube but unable to hold against gravity, 22=Grips cube, held against gravity but not against weak pull, 26=Grips cube against pull but weaker than left side, 33=Normal pinch grip. For elbow flexion and shoulder abduction, scoring was as follows: 0=No movement, 9=Palpable contraction in muscle but no movement, 14=Movement seen but not full range/not against gravity, 19=Full range against gravity, not against resistance, 25=Movement against resistance but weaker than left side, 33=Normal power. Both the right and the left side were tested.</description>
          <population>People with aphasia due to left hemisphere stroke</population>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pinch Grip Left Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33" spread="0"/>
                    <measurement group_id="O2" value="33" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pinch Grip Left 1 Day Post-treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33" spread="0"/>
                    <measurement group_id="O2" value="33" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Elbow Flexion Left Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33" spread="0"/>
                    <measurement group_id="O2" value="33" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Elbow Flexion Left 1 Day Post-treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33" spread="0"/>
                    <measurement group_id="O2" value="33" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Shoulder Abduction Left Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.6" spread="1.7"/>
                    <measurement group_id="O2" value="33" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Shoulder Abduction Left 1 Day Post-treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33" spread="0"/>
                    <measurement group_id="O2" value="33" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pinch Grip Right Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.9" spread="10.2"/>
                    <measurement group_id="O2" value="19.1" spread="15.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pinch Grip Right 1 Day Post-treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.9" spread="10.3"/>
                    <measurement group_id="O2" value="18.4" spread="16.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Elbow Flexion Right Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.4" spread="12.2"/>
                    <measurement group_id="O2" value="19.0" spread="14.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Elbow Flexion Right 1 Day Post-treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.0" spread="11.7"/>
                    <measurement group_id="O2" value="19.0" spread="14.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Shoulder Abduction Right Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.9" spread="11.7"/>
                    <measurement group_id="O2" value="17.0" spread="15.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Shoulder Abduction Right 1 Day Post-treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.7" spread="12.7"/>
                    <measurement group_id="O2" value="17.4" spread="14.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Transcranial Direct Current Stimulation</title>
          <description>Transcranial Direct Current Stimulation: The tDCS treatments will be applied bilaterally, with the anodal electrode placed on the left temple and the cathodal electrode placed on the right temple. The tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.</description>
        </group>
        <group group_id="E2">
          <title>Sham Stimulation</title>
          <description>Sham Stimulation: The sham tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </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="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </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>Elizabeth H. Lacey, PhD, Study Coordinator</name_or_title>
      <organization>Georgetown University</organization>
      <phone>202-877-1124 ext 202</phone>
      <email>ehl4@georgetown.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/NCT01709383
org study id: DDCF 2012062
nct id: NCT01709383
lead sponsor: 
collaborator: 
has dmc: No
This study tests whether weak electrical stimulation of the brain is effective in improving
      language or reading difficulties occurring after a brain injury or stroke.
This study tests whether aphasia or alexia, language and reading disorders occurring after
      traumatic brain injury or stroke, can be improved using transcranial direct current
      stimulation (tDCS). tDCS is a non-invasive technique that applies a small amount of direct
      electrical current to the brain in order to temporarily alter brain processing. Adults with
      aphasia/alexia resulting from stroke or traumatic brain injury will undergo baseline
      behavioral testing of various language and cognitive functions. Subjects who are willing to
      undergo MRI evaluation will also be scanned. They will then receive five days of either real
      or sham tDCS with standardized speech-language therapy, under a double-blind randomized
      placebo-controlled design. Behavioral assessments, and MRIs for those participating in the
      MRI portion of the study, will be performed again at multiple time points after completing
      tDCS to assess for changes in these measures.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Western Aphasia Battery - Revised: Naming and Word Finding Score
time frame: Change from baseline to one day after treatment
description: This is a composite measure of verbal expression skills including tests of naming, verbal fluency, sentence completion, and responsive naming (one-word answers to basic questions). It is a subtest within the Western Aphasia Battery. The minimum score is 0 and maximum is 10, with 10 being the best outcome, and subscores are summed to determine the total score.
measure: Western Aphasia Battery - Revised: Spontaneous Speech, Repetition, Auditory Verbal Comprehension and Overall Aphasia Quotient
time frame: Change from baseline to 1 day after treatment
description: The above subtests will reflect the following: a composite measure of information content in conversational speech and picture description (scored from 0 (no speech produced or only meaningless utterances) to 10 (no signs of aphasia)); a measure of word and sentence repetition (scored from 0 (unable to repeat any part of a single word) to 100 (perfect repetition of all words and up to a 10 word sentence)); a composite measure of yes/no questions, auditory word recognition, and following sequential commands (composite subscore is from 1 to 10, with 10 being the best outcome); and an overall aphasia severity score (composite score, or Aphasia Quotient, comprised of all the above measures plus the naming and word finding score used as the primary outcome measure. Quotient scores range from 0 to 100, with 100 indicating no aphasia is present).
measure: Philadelphia Naming Test (PNT)
time frame: 1 day after treatment
description: A test of picture naming using more common items than other picture naming tests, which reduces relationships between performance and premorbid education and socioeconomic status. There are 60 items on the test. A score of 0 means no pictures were named correctly. A score of 60 means all pictures were named correctly.
measure: Subjective Assessments Including: Communicative Effectiveness Index (CETI), Stroke and Aphasia Quality of Life Scale (SAQOL), and Stroke Aphasic Depression Questionnaire (SADQ)
time frame: 3 weeks post-treatment
description: Questionnaires were given at baseline, 3 weeks and 3 months after treatment. The SADQ consists of 21 questions graded on a 0-3 scale with 3 indicating the highest depression symptoms and 0 indicating none. Therefore, means reported below are an average score between 0 and 3. The SAQOL includes 17 questions about functional physical limitations and 7 questions about functional communication limitations in daily life. Questions are rated on a 1-5 scale with a score of 1 indicating greater disability and 5 indicating none. Therefore, means reported below are an average score between 1 and 5. The CETI measures change in functional communication by asking caregivers to make a mark on a straight line with "as able as before the stroke" written on the right side of the line and "not at all as able" on the left. The 16 responses are then converted by measuring the location of the mark on the line. A score of 10 indicates "as able as before the stroke" and 0 indicates "not at all as able".
measure: Cognitive-Linguistic Quick Test (CLQT)
time frame: Change from baseline to 1 day after treatment
description: The following subtests from the CLQT will be administered: Symbol Cancellation, Story Retelling, Generative Naming, Symbol Trails, Design Memory, Mazes,and Design Generation. These scores will be used to calculate composite scores for the cognitive domains of Attention, Executive Function (EF), and Visuospatial skills (VS). Some tests are weighted more than others in each composite score, by multiplying the score as follows and then adding the scores together: Attention = Symbol Cancellation (x9), Story Retelling (x2), Symbol Trails (x3), Mazes (x4), and Design Generation (x1); EF = sum of Symbol Trails, Generative Naming, Mazes, and Design Generation; VS = Symbol Cancellation (x2), Symbol Trails (x2), Design Memory (x4), Mazes (x3), Design Generation (x1). For all composite scores, a low number indicates greater deficit. For Attention, the highest score is 215 and lowest is 0. For EF, the highest score is 40 and lowest is 0. For VS, the highest score is 105 and lowest is 0
measure: Reading Assessments
time frame: Change from baseline to 1 day after treatment
description: A set of reading tasks designed to assess oral reading of real words and non-words at the single word level. The list of real words consisted of 142 words. A score of 0 indicates no words were read correctly and a score of 142 indicates all words were read correctly. The non-word test included 30 non-words. A score of 0 indicates no non-words were read correctly and a score of 30 indicates that all non-words were read correctly.
measure: Motricity Index
time frame: Change from baseline to 1 day after treatment
description: An assessment of upper extremity motor impairment, including: pinch grip, elbow flexion, and shoulder abduction. For pinch grip, which consisted of holding a small plastic cube between the thumb and index finger, scoring was as follows: 0=No movement, 11=Beginnings of prehension, 19=Grips cube but unable to hold against gravity, 22=Grips cube, held against gravity but not against weak pull, 26=Grips cube against pull but weaker than left side, 33=Normal pinch grip. For elbow flexion and shoulder abduction, scoring was as follows: 0=No movement, 9=Palpable contraction in muscle but no movement, 14=Movement seen but not full range/not against gravity, 19=Full range against gravity, not against resistance, 25=Movement against resistance but weaker than left side, 33=Normal power. Both the right and the left side were tested.
arm group label: Transcranial Direct Current Stimulation
arm group type: Active Comparator
description: TDCS was applied bilaterally, with the anodal electrode on the left temple and cathodal electrode on the right. TDCS was applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period
arm group label: Sham Stimulation
arm group type: Sham Comparator
description: Sham tDCS was applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.
intervention type: Device
intervention name: Transcranial Direct Current Stimulation
description: The tDCS treatments will be applied bilaterally, with the anodal electrode placed on the left temple and the cathodal electrode placed on the right temple. The tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.
arm group label: Transcranial Direct Current Stimulation
intervention type: Device
intervention name: Sham Stimulation
description: The sham tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.
arm group label: Sham Stimulation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Peter Turkeltaub, M.D., Ph.D.
role: Principal Investigator
affiliation: Georgetown University and MedStar National Rehabilitation Hospital
facility: 
facility: 
country: United States
citation: Zaghi S, Acar M, Hultgren B, Boggio PS, Fregni F. Noninvasive brain stimulation with low-intensity electrical currents: putative mechanisms of action for direct and alternating current stimulation. Neuroscientist. 2010 Jun;16(3):285-307. doi: 10.1177/1073858409336227. Epub 2009 Dec 29.
PMID: 20040569
citation: Schlaug G, Marchina S, Wan CY. The use of non-invasive brain stimulation techniques to facilitate recovery from post-stroke aphasia. Neuropsychol Rev. 2011 Sep;21(3):288-301. doi: 10.1007/s11065-011-9181-y. Epub 2011 Aug 14.
PMID: 21842404
citation: Fridriksson J, Richardson JD, Baker JM, Rorden C. Transcranial direct current stimulation improves naming reaction time in fluent aphasia: a double-blind, sham-controlled study. Stroke. 2011 Mar;42(3):819-21. doi: 10.1161/STROKEAHA.110.600288. Epub 2011 Jan 13.
PMID: 21233468
responsible party type: Sponsor
mesh term: Aphasia
sharing ipd: Undecided
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 