<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/NCT01686373</url>
  </required_header>
  <id_info>
    <org_study_id>11560FA12</org_study_id>
    <secondary_id>U01DC011739</secondary_id>
    <nct_id>NCT01686373</nct_id>
  </id_info>
  <brief_title>Brain Stimulation and Aphasia Treatment</brief_title>
  <acronym>tDCS</acronym>
  <official_title>Transcranial Direct Current Stimulation and Aphasia Treatment Outcomes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of South Carolina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Deafness and Other Communication Disorders (NIDCD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Medical University of South Carolina</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of South Carolina</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the changes in language processing of patients with&#xD;
      chronic, post-stroke aphasia following the application of brain stimulation. The brain&#xD;
      stimulation the investigators administer is called transcranial direct current stimulation&#xD;
      (tDCS). It involves passing a weak electrical current through the brain between two&#xD;
      electrodes in the form of damp sponges. One sponge will be placed over a specified area on&#xD;
      the damaged left hemisphere, while the other sponge will be placed on the right scalp.&#xD;
      Computer-controlled speech-language treatment will be administered during the application of&#xD;
      tDCS.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Stroke is the leading cause of adult disability in the United States. Approximately one-third&#xD;
      of all strokes result in acute language impairment (aphasia), with approximately one-fifth&#xD;
      suffering from chronic aphasia. Unfortunately, the prognosis for moderate to severe chronic&#xD;
      aphasia remains grim, as current behavioral treatment approaches usually offer only&#xD;
      limited-to-modest benefit. Recent advancements in understanding the relationship between low&#xD;
      current electrical brain stimulation and cortical plasticity suggest that the effect of&#xD;
      behavioral aphasia treatment could possibly be enhanced using anodal transcranial direct&#xD;
      current stimulation (A-tDCS). Indeed, we have shown how A-tDCS can significantly boost the&#xD;
      effect of behavioral aphasia treatment. Based on these results as well as our other studies&#xD;
      aimed at understanding how favorable brain plasticity correlates with positive treatment&#xD;
      outcome in aphasia, we propose to conduct a Phase II clinical trial utilizing a futility&#xD;
      design. Consistent with the goals of Program Announcement PAR-08-204 by the National&#xD;
      Institute on Deafness and Other Communication Disorders (NIDCD), we plan to &quot;evaluate whether&#xD;
      there is sufficient evidence of short term improvement in humans to justify a phase III&#xD;
      trial.&quot;&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2012</start_date>
  <completion_date type="Actual">October 2017</completion_date>
  <primary_completion_date type="Actual">May 2017</primary_completion_date>
  <phase>Phase 2</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>The Philadelphia Naming Test (PNT) Plus the Naming 80 (a Portion of the Trained Items).</measure>
    <time_frame>Immediately post-treatment</time_frame>
    <description>The PNT includes 175 items and has a minimum score of 0 (zero items named correctly) and a maximum score of 175 (all items named correctly). The Naming 80 includes a portion of the trained treatment items (N=80) with a minimum score of 0 (zero items named correctly) and a maximum score of 80 (all items named correctly). For both scales, higher values represent better outcome. The average of two administrations of the PNT were added to the the average of two administrations of the Naming 80 for both time points. The outcome measure is the change in that value (averaged PNT + averaged Naming 80) from baseline to immediately post-treatment. Only two timepoints are used for this calculation: baseline and immediately post-treatment.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">74</enrollment>
  <condition>Aphasia</condition>
  <arm_group>
    <arm_group_label>Activa Dose II Real tDCS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Actual delivery of electrical stimulation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Activa Dose II Sham tDCS</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Sham delivery of electrical stimulation</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Activa Dose II Real tDCS</intervention_name>
    <description>20 minutes of 1 milliamp active tDCS per treatment day (15 total sessions)</description>
    <arm_group_label>Activa Dose II Real tDCS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Activa Dose II Sham tDCS</intervention_name>
    <description>20 minutes of sham stimulation per treatment day (15 total sessions)</description>
    <arm_group_label>Activa Dose II Sham tDCS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients must be willing and able to give informed consent.&#xD;
&#xD;
          2. Patients must be willing and able to comply with study requirements.&#xD;
&#xD;
          3. Patients must be between 25- and 80-years of age.&#xD;
&#xD;
          4. Patients must be native English speakers.&#xD;
&#xD;
          5. Patients must be pre-morbidly right-handed.&#xD;
&#xD;
          6. Patients must have sustained a one-time ischemic stroke in the left-hemisphere.&#xD;
&#xD;
          7. Patients must be greater than 6-months post-stroke.&#xD;
&#xD;
          8. Patients must have an aphasia diagnosis as confirmed by the Western Aphasia&#xD;
             Battery-Revised.&#xD;
&#xD;
          9. Patients must be MRI-compatible (e.g., no metal implants, not claustrophobic, etc.).&#xD;
&#xD;
         10. Patients must achieve at least 65% accuracy on naming task during screening -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of brain surgery&#xD;
&#xD;
          2. Seizures during the previous 12 months&#xD;
&#xD;
          3. Sensitive scalp (per patient report)&#xD;
&#xD;
          4. Able to overtly name more than an average of 140 out of 175 items during the&#xD;
             pre-treatment picture naming test (Philadelphia Naming Test) during Visits 2 or 3.&#xD;
&#xD;
          5. Unable to overtly name at least an average of 5 out of 80 items during the&#xD;
             pre-treatment functional magnetic resonance imaging (fMRI) sessions during Visits 2 or&#xD;
             3.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Julius Fridriksson, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Director</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of South Carolina (USC)</name>
      <address>
        <city>Columbia</city>
        <state>South Carolina</state>
        <zip>29208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://sph.sc.edu/comd/fridriks/</url>
    <description>University of South Carolina Aphasia Laboratory</description>
  </link>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>September 7, 2012</study_first_submitted>
  <study_first_submitted_qc>September 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2012</study_first_posted>
  <results_first_submitted>April 17, 2019</results_first_submitted>
  <results_first_submitted_qc>July 31, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">August 20, 2019</results_first_posted>
  <last_update_submitted>July 31, 2019</last_update_submitted>
  <last_update_submitted_qc>July 31, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of South Carolina</investigator_affiliation>
    <investigator_full_name>Julius Fridriksson</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Aphasia</keyword>
  <keyword>Brain</keyword>
  <keyword>Stimulation</keyword>
  <keyword>Communication</keyword>
  <keyword>Stoke</keyword>
  <keyword>Post</keyword>
  <keyword>Phase II Clinical Trial</keyword>
  <keyword>Treatment</keyword>
  <keyword>tDCS</keyword>
  <keyword>Fridriksson</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aphasia</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 29, 2012</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/73/NCT01686373/SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 20, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/73/NCT01686373/Prot_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Activa Dose II Real tDCS</title>
          <description>Actual delivery of electrical stimulation&#xD;
Activa Dose II Real tDCS</description>
        </group>
        <group group_id="P2">
          <title>Activa Dose II Sham tDCS</title>
          <description>Sham delivery of electrical stimulation&#xD;
Activa Dose II Sham tDCS</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
                <participants group_id="P2" count="40"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received 15 Treatment Sessions</title>
              <participants_list>
                <participants group_id="P1" count="33"/>
                <participants group_id="P2" count="39"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="31"/>
                <participants group_id="P2" count="38"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
              </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="3"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Activa Dose II Real tDCS</title>
          <description>Actual delivery of electrical stimulation&#xD;
Activa Dose II Real tDCS</description>
        </group>
        <group group_id="B2">
          <title>Activa Dose II Sham tDCS</title>
          <description>Sham delivery of electrical stimulation&#xD;
Activa Dose II Sham tDCS</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="34"/>
            <count group_id="B2" value="40"/>
            <count group_id="B3" value="74"/>
          </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" spread="11"/>
                    <measurement group_id="B2" value="60" spread="10"/>
                    <measurement group_id="B3" value="60" spread="10"/>
                  </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="10"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="52"/>
                  </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="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>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_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="62"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>The Philadelphia Naming Test (PNT) Plus the Naming 80 (a Portion of the Trained Items).</title>
        <description>The PNT includes 175 items and has a minimum score of 0 (zero items named correctly) and a maximum score of 175 (all items named correctly). The Naming 80 includes a portion of the trained treatment items (N=80) with a minimum score of 0 (zero items named correctly) and a maximum score of 80 (all items named correctly). For both scales, higher values represent better outcome. The average of two administrations of the PNT were added to the the average of two administrations of the Naming 80 for both time points. The outcome measure is the change in that value (averaged PNT + averaged Naming 80) from baseline to immediately post-treatment. Only two timepoints are used for this calculation: baseline and immediately post-treatment.</description>
        <time_frame>Immediately post-treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Activa Dose II Real tDCS</title>
            <description>Actual delivery of electrical stimulation&#xD;
Activa Dose II Real tDCS</description>
          </group>
          <group group_id="O2">
            <title>Activa Dose II Sham tDCS</title>
            <description>Sham delivery of electrical stimulation&#xD;
Activa Dose II Sham tDCS</description>
          </group>
        </group_list>
        <measure>
          <title>The Philadelphia Naming Test (PNT) Plus the Naming 80 (a Portion of the Trained Items).</title>
          <description>The PNT includes 175 items and has a minimum score of 0 (zero items named correctly) and a maximum score of 175 (all items named correctly). The Naming 80 includes a portion of the trained treatment items (N=80) with a minimum score of 0 (zero items named correctly) and a maximum score of 80 (all items named correctly). For both scales, higher values represent better outcome. The average of two administrations of the PNT were added to the the average of two administrations of the Naming 80 for both time points. The outcome measure is the change in that value (averaged PNT + averaged Naming 80) from baseline to immediately post-treatment. Only two timepoints are used for this calculation: baseline and immediately post-treatment.</description>
          <units>PNT and Naming 80 score</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.9" lower_limit="9.0" upper_limit="18.7"/>
                    <measurement group_id="O2" value="8.2" lower_limit="3.8" upper_limit="12.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Non-serious adverse events were collected until immediate post treatment testing sessions (2 weeks), and serious adverse events were collected until end of study (24 weeks).</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Activa Dose II Real tDCS</title>
          <description>Actual delivery of electrical stimulation&#xD;
Activa Dose II Real tDCS</description>
        </group>
        <group group_id="E2">
          <title>Activa Dose II Sham tDCS</title>
          <description>Sham delivery of electrical stimulation&#xD;
Activa Dose II Sham tDCS</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (12.0)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <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="34"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Convulsion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (12.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="34"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Julius Fridriksson</name_or_title>
      <organization>University of South Carolina</organization>
      <phone>1-803-777-5931</phone>
      <email>jfridrik@sc.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/NCT01686373
org study id: 11560FA12
secondary id: U01DC011739
nct id: NCT01686373
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of this study is to assess the changes in language processing of patients with
      chronic, post-stroke aphasia following the application of brain stimulation. The brain
      stimulation the investigators administer is called transcranial direct current stimulation
      (tDCS). It involves passing a weak electrical current through the brain between two
      electrodes in the form of damp sponges. One sponge will be placed over a specified area on
      the damaged left hemisphere, while the other sponge will be placed on the right scalp.
      Computer-controlled speech-language treatment will be administered during the application of
      tDCS.
Stroke is the leading cause of adult disability in the United States. Approximately one-third
      of all strokes result in acute language impairment (aphasia), with approximately one-fifth
      suffering from chronic aphasia. Unfortunately, the prognosis for moderate to severe chronic
      aphasia remains grim, as current behavioral treatment approaches usually offer only
      limited-to-modest benefit. Recent advancements in understanding the relationship between low
      current electrical brain stimulation and cortical plasticity suggest that the effect of
      behavioral aphasia treatment could possibly be enhanced using anodal transcranial direct
      current stimulation (A-tDCS). Indeed, we have shown how A-tDCS can significantly boost the
      effect of behavioral aphasia treatment. Based on these results as well as our other studies
      aimed at understanding how favorable brain plasticity correlates with positive treatment
      outcome in aphasia, we propose to conduct a Phase II clinical trial utilizing a futility
      design. Consistent with the goals of Program Announcement PAR-08-204 by the National
      Institute on Deafness and Other Communication Disorders (NIDCD), we plan to "evaluate whether
      there is sufficient evidence of short term improvement in humans to justify a phase III
      trial."
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The Philadelphia Naming Test (PNT) Plus the Naming 80 (a Portion of the Trained Items).
time frame: Immediately post-treatment
description: The PNT includes 175 items and has a minimum score of 0 (zero items named correctly) and a maximum score of 175 (all items named correctly). The Naming 80 includes a portion of the trained treatment items (N=80) with a minimum score of 0 (zero items named correctly) and a maximum score of 80 (all items named correctly). For both scales, higher values represent better outcome. The average of two administrations of the PNT were added to the the average of two administrations of the Naming 80 for both time points. The outcome measure is the change in that value (averaged PNT + averaged Naming 80) from baseline to immediately post-treatment. Only two timepoints are used for this calculation: baseline and immediately post-treatment.
arm group label: Activa Dose II Real tDCS
arm group type: Experimental
description: Actual delivery of electrical stimulation
arm group label: Activa Dose II Sham tDCS
arm group type: Placebo Comparator
description: Sham delivery of electrical stimulation
intervention type: Device
intervention name: Activa Dose II Real tDCS
description: 20 minutes of 1 milliamp active tDCS per treatment day (15 total sessions)
arm group label: Activa Dose II Real tDCS
intervention type: Device
intervention name: Activa Dose II Sham tDCS
description: 20 minutes of sham stimulation per treatment day (15 total sessions)
arm group label: Activa Dose II Sham tDCS
criteria: 
gender: All
minimum age: 25 Years
maximum age: 80 Years
healthy volunteers: No
last name: Julius Fridriksson, PhD
role: Principal Investigator
affiliation: Director
facility: 
facility: 
country: United States
url: http://sph.sc.edu/comd/fridriks/
description: University of South Carolina Aphasia Laboratory
responsible party type: Principal Investigator
investigator affiliation: University of South Carolina
investigator full name: Julius Fridriksson
investigator title: Professor
mesh term: Aphasia
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 