<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/NCT02998684</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00056912</org_study_id>
    <nct_id>NCT02998684</nct_id>
  </id_info>
  <brief_title>Learning Enhancement Through Neurostimulation in Autism</brief_title>
  <acronym>LENS</acronym>
  <official_title>Learning Enhancement Through Neurostimulation in Autism</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of South Carolina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Medical University of South Carolina</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will examine whether brain stimulation paired with social skills learning can help&#xD;
      teenage boys with autism learn how to make and keep friends. Brain stimulation can enhance&#xD;
      learning in some people. This study involves enrolling in a 14-week training program where&#xD;
      teenage boys with autism interact in small groups and learn social skills. During the 14-week&#xD;
      program participants will receive active brain stimulation, or non-active stimulation&#xD;
      (placebo). Before and after this training, MRI scans will be taken to see whether the&#xD;
      training with active brain stimulation made a different in brain activation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2016</start_date>
  <completion_date type="Actual">July 2017</completion_date>
  <primary_completion_date type="Actual">July 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Test of Adolescent Social Skills Knowledge (TASSK)</measure>
    <time_frame>Baseline to 14-weeks</time_frame>
    <description>Change in TASSK raw scores from pre- to post-treatment, i.e., baseline to 14-weeks (Post minus pre-treatment: positive scores indicate improvement). Assessment scores can range from 0 to 26, 0 being the lowest possible score and 26 being the highest.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Social Responsiveness Scale (SRS)</measure>
    <time_frame>Baseline to 14 weeks</time_frame>
    <description>Change in SRS raw scores from pre- to post-treatment, i.e., baseline to 14-weeks (Pre minus post-treatment: positive scores indicate improvement). Raw scores range from 0 to 195, with higher scores indicating greater severity of symptoms.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Autism</condition>
  <arm_group>
    <arm_group_label>Active Transcranial Direct Current Stimulation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive active Transcranial Direct Current Stimulation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham Transcranial Direct Current Stimulation</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Participants will receive sham Transcranial Direct Current Stimulation</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Active Transcranial Direct Current Stimulation</intervention_name>
    <arm_group_label>Active Transcranial Direct Current Stimulation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham Transcranial Direct Current Stimulation</intervention_name>
    <arm_group_label>Sham Transcranial Direct Current Stimulation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>PEERS Social Skills Training</intervention_name>
    <description>14 weekly social skills training sessions for all participants</description>
    <arm_group_label>Active Transcranial Direct Current Stimulation</arm_group_label>
    <arm_group_label>Sham Transcranial Direct Current Stimulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Autism Spectrum Disorder&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Intellectual Disabilities (Full-scale IQ &lt;70)&#xD;
&#xD;
          -  Hx of seizures within the last one year&#xD;
&#xD;
          -  Contraindications for fMRI, such as metal implants in the head&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jane Joseph, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of South Carolina</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical Univeristy of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>December 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <results_first_submitted>July 25, 2018</results_first_submitted>
  <results_first_submitted_qc>August 29, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">September 4, 2018</results_first_posted>
  <last_update_submitted>August 29, 2018</last_update_submitted>
  <last_update_submitted_qc>August 29, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 4, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Autism</keyword>
  <keyword>Adolescent</keyword>
  <keyword>Social skills</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Autistic Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 28, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/84/NCT02998684/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Active Transcranial Direct Current Stimulation</title>
          <description>Participants will receive active Transcranial Direct Current Stimulation&#xD;
Active Transcranial Direct Current Stimulation&#xD;
PEERS Social Skills Training: 14 weekly social skills training sessions for all participants</description>
        </group>
        <group group_id="P2">
          <title>Sham Transcranial Direct Current Stimulation</title>
          <description>Participants will receive sham Transcranial Direct Current Stimulation&#xD;
Sham Transcranial Direct Current Stimulation&#xD;
PEERS Social Skills Training: 14 weekly social skills training sessions for all participants</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Active Transcranial Direct Current Stimulation</title>
          <description>Participants will receive active Transcranial Direct Current Stimulation&#xD;
Active Transcranial Direct Current Stimulation&#xD;
PEERS Social Skills Training: 14 weekly social skills training sessions for all participants</description>
        </group>
        <group group_id="B2">
          <title>Sham Transcranial Direct Current Stimulation</title>
          <description>Participants will receive sham Transcranial Direct Current Stimulation&#xD;
Sham Transcranial Direct Current Stimulation&#xD;
PEERS Social Skills Training: 14 weekly social skills training sessions for all participants</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="7"/>
            <count group_id="B2" value="7"/>
            <count group_id="B3" value="14"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</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>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Caucasian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black/African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </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="7"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Test of Adolescent Social Skills Knowledge (TASSK)</title>
        <description>Change in TASSK raw scores from pre- to post-treatment, i.e., baseline to 14-weeks (Post minus pre-treatment: positive scores indicate improvement). Assessment scores can range from 0 to 26, 0 being the lowest possible score and 26 being the highest.</description>
        <time_frame>Baseline to 14-weeks</time_frame>
        <population>Number of participants who completed study questionnaire pre and post-treatment</population>
        <group_list>
          <group group_id="O1">
            <title>Active Transcranial Direct Current Stimulation</title>
            <description>Participants will receive active Transcranial Direct Current Stimulation&#xD;
Active Transcranial Direct Current Stimulation&#xD;
PEERS Social Skills Training: 14 weekly social skills training sessions for all participants</description>
          </group>
          <group group_id="O2">
            <title>Sham Transcranial Direct Current Stimulation</title>
            <description>Participants will receive sham Transcranial Direct Current Stimulation&#xD;
Sham Transcranial Direct Current Stimulation&#xD;
PEERS Social Skills Training: 14 weekly social skills training sessions for all participants</description>
          </group>
        </group_list>
        <measure>
          <title>Test of Adolescent Social Skills Knowledge (TASSK)</title>
          <description>Change in TASSK raw scores from pre- to post-treatment, i.e., baseline to 14-weeks (Post minus pre-treatment: positive scores indicate improvement). Assessment scores can range from 0 to 26, 0 being the lowest possible score and 26 being the highest.</description>
          <population>Number of participants who completed study questionnaire pre and post-treatment</population>
          <units>score 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="3"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8" spread="2"/>
                    <measurement group_id="O2" value="3.5" spread="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Social Responsiveness Scale (SRS)</title>
        <description>Change in SRS raw scores from pre- to post-treatment, i.e., baseline to 14-weeks (Pre minus post-treatment: positive scores indicate improvement). Raw scores range from 0 to 195, with higher scores indicating greater severity of symptoms.</description>
        <time_frame>Baseline to 14 weeks</time_frame>
        <population>Data for participants who completed all 14 weeks</population>
        <group_list>
          <group group_id="O1">
            <title>Active Transcranial Direct Current Stimulation</title>
            <description>Participants will receive active Transcranial Direct Current Stimulation&#xD;
Active Transcranial Direct Current Stimulation&#xD;
PEERS Social Skills Training: 14 weekly social skills training sessions for all participants</description>
          </group>
          <group group_id="O2">
            <title>Sham Transcranial Direct Current Stimulation</title>
            <description>Participants will receive sham Transcranial Direct Current Stimulation&#xD;
Sham Transcranial Direct Current Stimulation&#xD;
PEERS Social Skills Training: 14 weekly social skills training sessions for all participants</description>
          </group>
        </group_list>
        <measure>
          <title>Social Responsiveness Scale (SRS)</title>
          <description>Change in SRS raw scores from pre- to post-treatment, i.e., baseline to 14-weeks (Pre minus post-treatment: positive scores indicate improvement). Raw scores range from 0 to 195, with higher scores indicating greater severity of symptoms.</description>
          <population>Data for participants who completed all 14 weeks</population>
          <units>score 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="4"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.5" spread="18.2"/>
                    <measurement group_id="O2" value="26.5" spread="22.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>14 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Active Transcranial Direct Current Stimulation</title>
          <description>Participants will receive active Transcranial Direct Current Stimulation&#xD;
Active Transcranial Direct Current Stimulation&#xD;
PEERS Social Skills Training: 14 weekly social skills training sessions for all participants</description>
        </group>
        <group group_id="E2">
          <title>Sham Transcranial Direct Current Stimulation</title>
          <description>Participants will receive sham Transcranial Direct Current Stimulation&#xD;
Sham Transcranial Direct Current Stimulation&#xD;
PEERS Social Skills Training: 14 weekly social skills training sessions for all participants</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
              </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="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
              </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. Jane Joseph</name_or_title>
      <organization>Medical University of South Carolina</organization>
      <phone>843-792-7683</phone>
      <email>josep@musc.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/NCT02998684
org study id: Pro00056912
nct id: NCT02998684
lead sponsor: 
collaborator: 
has dmc: Yes
This study will examine whether brain stimulation paired with social skills learning can help
      teenage boys with autism learn how to make and keep friends. Brain stimulation can enhance
      learning in some people. This study involves enrolling in a 14-week training program where
      teenage boys with autism interact in small groups and learn social skills. During the 14-week
      program participants will receive active brain stimulation, or non-active stimulation
      (placebo). Before and after this training, MRI scans will be taken to see whether the
      training with active brain stimulation made a different in brain activation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Test of Adolescent Social Skills Knowledge (TASSK)
time frame: Baseline to 14-weeks
description: Change in TASSK raw scores from pre- to post-treatment, i.e., baseline to 14-weeks (Post minus pre-treatment: positive scores indicate improvement). Assessment scores can range from 0 to 26, 0 being the lowest possible score and 26 being the highest.
measure: Social Responsiveness Scale (SRS)
time frame: Baseline to 14 weeks
description: Change in SRS raw scores from pre- to post-treatment, i.e., baseline to 14-weeks (Pre minus post-treatment: positive scores indicate improvement). Raw scores range from 0 to 195, with higher scores indicating greater severity of symptoms.
arm group label: Active Transcranial Direct Current Stimulation
arm group type: Active Comparator
description: Participants will receive active Transcranial Direct Current Stimulation
arm group label: Sham Transcranial Direct Current Stimulation
arm group type: Sham Comparator
description: Participants will receive sham Transcranial Direct Current Stimulation
intervention type: Device
intervention name: Active Transcranial Direct Current Stimulation
arm group label: Active Transcranial Direct Current Stimulation
intervention type: Device
intervention name: Sham Transcranial Direct Current Stimulation
arm group label: Sham Transcranial Direct Current Stimulation
intervention type: Behavioral
intervention name: PEERS Social Skills Training
description: 14 weekly social skills training sessions for all participants
arm group label: Active Transcranial Direct Current Stimulation
arm group label: Sham Transcranial Direct Current Stimulation
criteria: 
gender: All
minimum age: 14 Years
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jane Joseph, PhD
role: Principal Investigator
affiliation: Medical University of South Carolina
facility: 
country: United States
responsible party type: Sponsor
mesh term: Autistic Disorder
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 