<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/NCT02250092</url>
  </required_header>
  <id_info>
    <org_study_id>1408M53169</org_study_id>
    <nct_id>NCT02250092</nct_id>
  </id_info>
  <brief_title>Brain Stimulation and Hand Training in Children With Hemiparesis</brief_title>
  <official_title>Synergistic Effect of Combined Transcranial Direct Current Stimulation/Constraint Induced Movement Therapy in Children With Hemiparesis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cerebral Palsy International Research Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Foundation for Physical Therapy, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Minnesota</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hemiparetic cerebral palsy influences motor function in children during development and&#xD;
      throughout their lifetime. The deficits one sees are the result both of the congenitally&#xD;
      induced brain lesion and the subsequent plasticity that can impair function of the surviving&#xD;
      neurons in the damaged brain.&#xD;
&#xD;
      Many current treatments have limited influence on children's neurorecovery.&#xD;
      Constraint-induced movement therapy (CIMT) involving constraining the unaffected limb to&#xD;
      encourage use of the affected limb has shown promise, yet with new technology revealing the&#xD;
      potential to directly influence the brain, there is an urgent need to study the synergy of&#xD;
      combined techniques.&#xD;
&#xD;
      Non-invasive brain stimulation (NIBS) as a direct neuromodulatory intervention has the&#xD;
      potential to act synergistically with CIMT to influence neurorecovery.&#xD;
&#xD;
      Combining behavioral therapies, constraint-induced movement therapy (CIMT), with a novel form&#xD;
      of neuromodulation, transcranial direct current stimulation (tDCS), we investigated the&#xD;
      influence of this intervention on improved motor outcomes in children with cerebral palsy.&#xD;
      The study hypotheses surround the safety, feasibility and efficacy of combined CIMT and tDCS&#xD;
      wherein those children who receive the combined intervention will reveal no major adverse&#xD;
      events, yet improved hand function and cortical excitability.&#xD;
&#xD;
      To Note: In addition to the combination of NIBS with CIMT, we also investigated the&#xD;
      combination of NIBS with another form of motor intervention, bimanual, or two-handed,&#xD;
      training. During bimanual training, children engage both hands in movements. The goal of&#xD;
      bimanual training is to teach children how to most effectively use their hands cooperatively.&#xD;
      During bimanual training, children play with games and toys that require the use of both&#xD;
      hands. Children also practice activities of daily living that require the use of both hands,&#xD;
      such as putting hair in a ponytail, tying shoes, and buttoning clothing. N=8 for this pilot&#xD;
      study and no randomization. (Burke Medical Research Institute partnered with Columbia&#xD;
      University and did a parallel pilot study. N=8 (PIs Friel and Gordon; Protocol BRC449)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We use single-pulse transcranial magnetic stimulation (TMS) to measure the location and&#xD;
      strength of brain connections that control hand movements.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 31, 2014</start_date>
  <completion_date type="Actual">July 10, 2017</completion_date>
  <primary_completion_date type="Actual">June 28, 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>Change in Assisting Hand Assessment (AHA)</measure>
    <time_frame>2 weeks, 6 months</time_frame>
    <description>Participants were videotaped while performing a bimanual age-appropriate activity. Investigators scored this performance using the Assessment of Assisting Hand (AHA) inventory. The AHA consists of 22 items, each scored on a 4-point scale. Raw scores are a sum of the 22 item scores, ranging from 22-88. Computer software logarithmically transforms ordinal raw scores into a final score. Final scores are reported on a logit-based AHA-unit scale and range from 0 to 100, with higher scores indicating greater ability. Outcome is reported as the change from baseline to 2 weeks and change from baseline to 6 months.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Canadian Occupational Performance Measurement (COPM)</measure>
    <time_frame>2 weeks, 6 months</time_frame>
    <description>The COPM is clinician-administered semi-structured interview measuring the participant's perception of satisfaction and performance of personally set goals. There are 3 categories (Self-Care, Productivity, and Leisure) each containing 3 subcategories each for a total of 9 items, which are rated on an ordinal scale from 1 (minimum importance) to 10 (maximum importance). Each of the child's goals are given a satisfaction and performance rating. The average of the satisfaction ratings across all goals is reported as the &quot;average satisfaction score&quot;, ranging from 1 to 10, with higher scores indicating a better outcome. Outcome is reported as the change from baseline to 2 weeks and change from baseline to 6 months.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in Subject Symptom Assessment (SSA) From 2 Weeks to 6 Months</measure>
    <time_frame>2 weeks, 6 months</time_frame>
    <description>The Subject Symptom Assessment (SSA) is a questionnaire of common side effects reported in the literature that is asked of the child undergoing non-invasive brain stimulation. This measure asks the child to rate if the symptom is present (yes or no) and if it is present, rate the severity using a 1 to 4 scale (1 indicates absent, 2=mild, 3=moderate, 4=severe). Lower values are better as they represent absent or mild symptoms. Outcome is reported as the change in symptom severity from 2 weeks of treatment to 6 months of treatment. This measure is not collected at baseline.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Pediatric Hemiparesis</condition>
  <arm_group>
    <arm_group_label>tDCS/CIMT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention Group will receive 20 minutes of 1.0 mA tDCS to the contralesional hemisphere concurrent with CIMT.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>tDCS sham/CIMT</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo Group will receive 20 minutes of sham 1.0 mA tDCS to the contralesional hemisphere concurrent with CIMT.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Transcranial Direct Current Stimulation (tDCS)</intervention_name>
    <description>10 tDCS/CIMT Sessions</description>
    <arm_group_label>tDCS/CIMT</arm_group_label>
    <other_name>tDCS</other_name>
    <other_name>Brain Stimulation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Placebo Comparator</intervention_name>
    <arm_group_label>tDCS sham/CIMT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Hemispheric Stroke or Periventricular Leukomalacia confirmed by most recent MRI or CT&#xD;
             radiologic report with resultant congenital hemiparesis&#xD;
&#xD;
          2. ≥ 10 degrees of active motion at the metacarpophalangeal joint&#xD;
&#xD;
          3. Receptive language function to follow two-step commands as evidenced by performance on&#xD;
             TOKEN test of intelligence&#xD;
&#xD;
          4. No evidence of seizure activity within the last 2 years&#xD;
&#xD;
          5. Presence of a motor evoked potential from at least the contralesional hemisphere if&#xD;
             not both hemispheres&#xD;
&#xD;
          6. Ages 8-21 years&#xD;
&#xD;
          7. Able to give informed assent along with the informed consent of the legal guardian&#xD;
&#xD;
          8. Children who have had surgeries, which may influence motor function eg- tendon&#xD;
             transfer, will be included, yet surgical history will be documented and included in&#xD;
             any publication within a participant characteristics table.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Metabolic Disorders&#xD;
&#xD;
          2. Neoplasm&#xD;
&#xD;
          3. Epilepsy&#xD;
&#xD;
          4. Disorders of Cellular Migration and Proliferation&#xD;
&#xD;
          5. Acquired Traumatic Brain Injury&#xD;
&#xD;
          6. Pregnancy&#xD;
&#xD;
          7. Indwelling metal or incompatible medical devices&#xD;
&#xD;
          8. Evidence of skin disease or skin abnormalities&#xD;
&#xD;
          9. Botulinum toxin or Phenol block within [six-months] preceding the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bernadette T Gillick, PhD, MSPT, PT</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Minnesota</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Minnesota</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gillette Children's Specialty Healthcare</name>
      <address>
        <city>Saint Paul</city>
        <state>Minnesota</state>
        <zip>55101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Gillick B, Menk J, Mueller B, Meekins G, Krach LE, Feyma T, Rudser K. Synergistic effect of combined transcranial direct current stimulation/constraint-induced movement therapy in children and young adults with hemiparesis: study protocol. BMC Pediatr. 2015 Nov 12;15:178. doi: 10.1186/s12887-015-0498-1.</citation>
    <PMID>26558386</PMID>
  </reference>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>September 18, 2014</study_first_submitted>
  <study_first_submitted_qc>September 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <results_first_submitted>December 9, 2019</results_first_submitted>
  <results_first_submitted_qc>August 6, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">August 18, 2020</results_first_posted>
  <last_update_submitted>August 6, 2020</last_update_submitted>
  <last_update_submitted_qc>August 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cerebral Palsy</keyword>
  <keyword>Hemiparesis</keyword>
  <keyword>Stroke</keyword>
  <keyword>Non-Invasive Brain Stimulation</keyword>
  <keyword>Transcranial Direct Current Stimulation</keyword>
  <keyword>Constraint-Induced Movement Therapy</keyword>
  <keyword>Diffusion Tensor Imaging</keyword>
  <keyword>Congenital Hemiparesis</keyword>
  <keyword>Bimanual Therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paresis</mesh_term>
  </condition_browse>
  <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>May 9, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/92/NCT02250092/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>tDCS/CIMT</title>
          <description>Intervention Group will receive 20 minutes of 1.0 mA tDCS to the contralesional hemisphere concurrent with CIMT.&#xD;
Transcranial Direct Current Stimulation (tDCS): 10 tDCS/CIMT Sessions</description>
        </group>
        <group group_id="P2">
          <title>tDCS Sham/CIMT</title>
          <description>Placebo Group will receive 20 minutes of sham 1.0 mA tDCS to the contralesional hemisphere concurrent with CIMT.&#xD;
Placebo Comparator</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>tDCS/CIMT</title>
          <description>Intervention Group will receive 20 minutes of 1.0 mA tDCS to the contralesional hemisphere concurrent with CIMT.&#xD;
Transcranial Direct Current Stimulation (tDCS): 10 tDCS/CIMT Sessions</description>
        </group>
        <group group_id="B2">
          <title>tDCS Sham/CIMT</title>
          <description>Placebo Group will receive 20 minutes of sham 1.0 mA tDCS to the contralesional hemisphere concurrent with CIMT.&#xD;
Placebo Comparator</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="10"/>
            <count group_id="B2" value="10"/>
            <count group_id="B3" value="20"/>
          </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="10"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </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>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12.33" spread="3.08"/>
                    <measurement group_id="B2" value="13.17" spread="5.08"/>
                    <measurement group_id="B3" value="12.7" spread="4.17"/>
                  </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="5"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="10"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="8"/>
                  </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="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </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="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Assisting Hand Assessment (AHA)</title>
        <description>Participants were videotaped while performing a bimanual age-appropriate activity. Investigators scored this performance using the Assessment of Assisting Hand (AHA) inventory. The AHA consists of 22 items, each scored on a 4-point scale. Raw scores are a sum of the 22 item scores, ranging from 22-88. Computer software logarithmically transforms ordinal raw scores into a final score. Final scores are reported on a logit-based AHA-unit scale and range from 0 to 100, with higher scores indicating greater ability. Outcome is reported as the change from baseline to 2 weeks and change from baseline to 6 months.</description>
        <time_frame>2 weeks, 6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>tDCS/CIMT</title>
            <description>Intervention Group will receive 20 minutes of 1.0 mA tDCS to the contralesional hemisphere concurrent with CIMT.&#xD;
Transcranial Direct Current Stimulation (tDCS): 10 tDCS/CIMT Sessions</description>
          </group>
          <group group_id="O2">
            <title>tDCS Sham/CIMT</title>
            <description>Placebo Group will receive 20 minutes of sham 1.0 mA tDCS to the contralesional hemisphere concurrent with CIMT.&#xD;
Placebo Comparator</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Assisting Hand Assessment (AHA)</title>
          <description>Participants were videotaped while performing a bimanual age-appropriate activity. Investigators scored this performance using the Assessment of Assisting Hand (AHA) inventory. The AHA consists of 22 items, each scored on a 4-point scale. Raw scores are a sum of the 22 item scores, ranging from 22-88. Computer software logarithmically transforms ordinal raw scores into a final score. Final scores are reported on a logit-based AHA-unit scale and range from 0 to 100, with higher scores indicating greater ability. Outcome is reported as the change from baseline to 2 weeks and change from baseline to 6 months.</description>
          <units>score on a scale</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="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>2 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.4" lower_limit="3.4" upper_limit="9.4"/>
                    <measurement group_id="O2" value="8" lower_limit="5.66" upper_limit="10.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.5" lower_limit="3.23" upper_limit="7.77"/>
                    <measurement group_id="O2" value="7.6" lower_limit="3.92" upper_limit="11.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Canadian Occupational Performance Measurement (COPM)</title>
        <description>The COPM is clinician-administered semi-structured interview measuring the participant's perception of satisfaction and performance of personally set goals. There are 3 categories (Self-Care, Productivity, and Leisure) each containing 3 subcategories each for a total of 9 items, which are rated on an ordinal scale from 1 (minimum importance) to 10 (maximum importance). Each of the child's goals are given a satisfaction and performance rating. The average of the satisfaction ratings across all goals is reported as the &quot;average satisfaction score&quot;, ranging from 1 to 10, with higher scores indicating a better outcome. Outcome is reported as the change from baseline to 2 weeks and change from baseline to 6 months.</description>
        <time_frame>2 weeks, 6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>tDCS/CIMT</title>
            <description>Intervention Group will receive 20 minutes of 1.0 mA tDCS to the contralesional hemisphere concurrent with CIMT.&#xD;
Transcranial Direct Current Stimulation (tDCS): 10 tDCS/CIMT Sessions</description>
          </group>
          <group group_id="O2">
            <title>tDCS Sham/CIMT</title>
            <description>Placebo Group will receive 20 minutes of sham 1.0 mA tDCS to the contralesional hemisphere concurrent with CIMT.&#xD;
Placebo Comparator</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Canadian Occupational Performance Measurement (COPM)</title>
          <description>The COPM is clinician-administered semi-structured interview measuring the participant's perception of satisfaction and performance of personally set goals. There are 3 categories (Self-Care, Productivity, and Leisure) each containing 3 subcategories each for a total of 9 items, which are rated on an ordinal scale from 1 (minimum importance) to 10 (maximum importance). Each of the child's goals are given a satisfaction and performance rating. The average of the satisfaction ratings across all goals is reported as the &quot;average satisfaction score&quot;, ranging from 1 to 10, with higher scores indicating a better outcome. Outcome is reported as the change from baseline to 2 weeks and change from baseline to 6 months.</description>
          <units>score on a scale</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="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>2 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.14" lower_limit="1.23" upper_limit="3.05"/>
                    <measurement group_id="O2" value="1.8" lower_limit="1.27" upper_limit="2.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.94" lower_limit="2.04" upper_limit="3.84"/>
                    <measurement group_id="O2" value="3.22" lower_limit="2.57" upper_limit="3.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change in Subject Symptom Assessment (SSA) From 2 Weeks to 6 Months</title>
        <description>The Subject Symptom Assessment (SSA) is a questionnaire of common side effects reported in the literature that is asked of the child undergoing non-invasive brain stimulation. This measure asks the child to rate if the symptom is present (yes or no) and if it is present, rate the severity using a 1 to 4 scale (1 indicates absent, 2=mild, 3=moderate, 4=severe). Lower values are better as they represent absent or mild symptoms. Outcome is reported as the change in symptom severity from 2 weeks of treatment to 6 months of treatment. This measure is not collected at baseline.</description>
        <time_frame>2 weeks, 6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>tDCS/CIMT</title>
            <description>Intervention Group will receive 20 minutes of 1.0 mA tDCS to the contralesional hemisphere concurrent with CIMT.&#xD;
Transcranial Direct Current Stimulation (tDCS): 10 tDCS/CIMT Sessions</description>
          </group>
          <group group_id="O2">
            <title>tDCS Sham/CIMT</title>
            <description>Placebo Group will receive 20 minutes of sham 1.0 mA tDCS to the contralesional hemisphere concurrent with CIMT.&#xD;
Placebo Comparator</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Subject Symptom Assessment (SSA) From 2 Weeks to 6 Months</title>
          <description>The Subject Symptom Assessment (SSA) is a questionnaire of common side effects reported in the literature that is asked of the child undergoing non-invasive brain stimulation. This measure asks the child to rate if the symptom is present (yes or no) and if it is present, rate the severity using a 1 to 4 scale (1 indicates absent, 2=mild, 3=moderate, 4=severe). Lower values are better as they represent absent or mild symptoms. Outcome is reported as the change in symptom severity from 2 weeks of treatment to 6 months of treatment. This measure is not collected at baseline.</description>
          <units>score on a scale</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="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7" lower_limit="0.5" upper_limit="2.9"/>
                    <measurement group_id="O2" value="1.76" lower_limit="0.96" upper_limit="2.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>tDCS/CIMT</title>
          <description>Intervention Group will receive 20 minutes of 1.0 mA tDCS to the contralesional hemisphere concurrent with CIMT.&#xD;
Transcranial Direct Current Stimulation (tDCS): 10 tDCS/CIMT Sessions</description>
        </group>
        <group group_id="E2">
          <title>tDCS Sham/CIMT</title>
          <description>Placebo Group will receive 20 minutes of sham 1.0 mA tDCS to the contralesional hemisphere concurrent with CIMT.&#xD;
Placebo Comparator</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="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="9" subjects_affected="4" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Unusual Feelings on the Skin of the Head</sub_title>
                <counts group_id="E1" events="5" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Itchiness</sub_title>
                <counts group_id="E1" events="5" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="6" subjects_affected="3" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Unusual Feelings or Emotions</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Tingling</sub_title>
                <counts group_id="E1" events="10" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Difficulty Paying Attention</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Bernadette Gillick</name_or_title>
      <organization>University of Minnesota</organization>
      <phone>612-626-6415</phone>
      <email>gillick@umn.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/NCT02250092
org study id: 1408M53169
nct id: NCT02250092
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
Hemiparetic cerebral palsy influences motor function in children during development and
      throughout their lifetime. The deficits one sees are the result both of the congenitally
      induced brain lesion and the subsequent plasticity that can impair function of the surviving
      neurons in the damaged brain.

      Many current treatments have limited influence on children's neurorecovery.
      Constraint-induced movement therapy (CIMT) involving constraining the unaffected limb to
      encourage use of the affected limb has shown promise, yet with new technology revealing the
      potential to directly influence the brain, there is an urgent need to study the synergy of
      combined techniques.

      Non-invasive brain stimulation (NIBS) as a direct neuromodulatory intervention has the
      potential to act synergistically with CIMT to influence neurorecovery.

      Combining behavioral therapies, constraint-induced movement therapy (CIMT), with a novel form
      of neuromodulation, transcranial direct current stimulation (tDCS), we investigated the
      influence of this intervention on improved motor outcomes in children with cerebral palsy.
      The study hypotheses surround the safety, feasibility and efficacy of combined CIMT and tDCS
      wherein those children who receive the combined intervention will reveal no major adverse
      events, yet improved hand function and cortical excitability.

      To Note: In addition to the combination of NIBS with CIMT, we also investigated the
      combination of NIBS with another form of motor intervention, bimanual, or two-handed,
      training. During bimanual training, children engage both hands in movements. The goal of
      bimanual training is to teach children how to most effectively use their hands cooperatively.
      During bimanual training, children play with games and toys that require the use of both
      hands. Children also practice activities of daily living that require the use of both hands,
      such as putting hair in a ponytail, tying shoes, and buttoning clothing. N=8 for this pilot
      study and no randomization. (Burke Medical Research Institute partnered with Columbia
      University and did a parallel pilot study. N=8 (PIs Friel and Gordon; Protocol BRC449)
We use single-pulse transcranial magnetic stimulation (TMS) to measure the location and
      strength of brain connections that control hand movements.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Change in Assisting Hand Assessment (AHA)
time frame: 2 weeks, 6 months
description: Participants were videotaped while performing a bimanual age-appropriate activity. Investigators scored this performance using the Assessment of Assisting Hand (AHA) inventory. The AHA consists of 22 items, each scored on a 4-point scale. Raw scores are a sum of the 22 item scores, ranging from 22-88. Computer software logarithmically transforms ordinal raw scores into a final score. Final scores are reported on a logit-based AHA-unit scale and range from 0 to 100, with higher scores indicating greater ability. Outcome is reported as the change from baseline to 2 weeks and change from baseline to 6 months.
measure: Change in Canadian Occupational Performance Measurement (COPM)
time frame: 2 weeks, 6 months
description: The COPM is clinician-administered semi-structured interview measuring the participant's perception of satisfaction and performance of personally set goals. There are 3 categories (Self-Care, Productivity, and Leisure) each containing 3 subcategories each for a total of 9 items, which are rated on an ordinal scale from 1 (minimum importance) to 10 (maximum importance). Each of the child's goals are given a satisfaction and performance rating. The average of the satisfaction ratings across all goals is reported as the "average satisfaction score", ranging from 1 to 10, with higher scores indicating a better outcome. Outcome is reported as the change from baseline to 2 weeks and change from baseline to 6 months.
measure: Change in Subject Symptom Assessment (SSA) From 2 Weeks to 6 Months
time frame: 2 weeks, 6 months
description: The Subject Symptom Assessment (SSA) is a questionnaire of common side effects reported in the literature that is asked of the child undergoing non-invasive brain stimulation. This measure asks the child to rate if the symptom is present (yes or no) and if it is present, rate the severity using a 1 to 4 scale (1 indicates absent, 2=mild, 3=moderate, 4=severe). Lower values are better as they represent absent or mild symptoms. Outcome is reported as the change in symptom severity from 2 weeks of treatment to 6 months of treatment. This measure is not collected at baseline.
arm group label: tDCS/CIMT
arm group type: Active Comparator
description: Intervention Group will receive 20 minutes of 1.0 mA tDCS to the contralesional hemisphere concurrent with CIMT.
arm group label: tDCS sham/CIMT
arm group type: Placebo Comparator
description: Placebo Group will receive 20 minutes of sham 1.0 mA tDCS to the contralesional hemisphere concurrent with CIMT.
intervention type: Device
intervention name: Transcranial Direct Current Stimulation (tDCS)
description: 10 tDCS/CIMT Sessions
arm group label: tDCS/CIMT
other name: tDCS
other name: Brain Stimulation
intervention type: Device
intervention name: Placebo Comparator
arm group label: tDCS sham/CIMT
criteria: 
gender: All
minimum age: 8 Years
maximum age: 21 Years
healthy volunteers: No
last name: Bernadette T Gillick, PhD, MSPT, PT
role: Principal Investigator
affiliation: University of Minnesota
facility: 
facility: 
country: United States
citation: Gillick B, Menk J, Mueller B, Meekins G, Krach LE, Feyma T, Rudser K. Synergistic effect of combined transcranial direct current stimulation/constraint-induced movement therapy in children and young adults with hemiparesis: study protocol. BMC Pediatr. 2015 Nov 12;15:178. doi: 10.1186/s12887-015-0498-1.
PMID: 26558386
responsible party type: Sponsor
mesh term: Paresis
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 