<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/NCT02210403</url>
  </required_header>
  <id_info>
    <org_study_id>S54797</org_study_id>
    <nct_id>NCT02210403</nct_id>
  </id_info>
  <brief_title>The Influence of tDCS on the Arm and Hand Function in Stroke Patients</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitaire Ziekenhuizen KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitaire Ziekenhuizen KU Leuven</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether tDCS in combination with motor training can&#xD;
      improve hand and arm function in stroke patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 18, 2013</start_date>
  <completion_date type="Actual">September 28, 2014</completion_date>
  <primary_completion_date type="Actual">September 28, 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of Fugl-Meyer assessment (FMA) score</measure>
    <time_frame>Change from baseline in FMA score on the 3rd intervention day; change from baseline in FMA score at 1 week post intervention</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of Modified Ashworth scale (MAS)</measure>
    <time_frame>Change from baseline in MAS scale on the 3rd intervention day; change from baseline in MAS scale at 1 week post intervention</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Change of motor task performance</measure>
    <time_frame>Change from baseline motor task performance on the 3rd intervention day, and change from baseline in motor task performance at 1 week post intervention</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Transcranial Direct Current Stimulation</condition>
  <condition>Cerebrovascular Accident (CVA)</condition>
  <arm_group>
    <arm_group_label>Upper limb motor function training + tDCS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Bi-hemispheric tDCS with motor function training</description>
  </arm_group>
  <arm_group>
    <arm_group_label>upper limb motor function training + sham tDCS</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>sham tDCS with motor function training</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>transcranial direct current stimulation (tDCS)</intervention_name>
    <arm_group_label>Upper limb motor function training + tDCS</arm_group_label>
    <arm_group_label>upper limb motor function training + sham tDCS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Stroke patients onset &gt; 6 months&#xD;
&#xD;
          -  First ever stroke&#xD;
&#xD;
          -  Decreased hand and arm function&#xD;
&#xD;
          -  Mini Mental State Examination (&gt;24)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Depression&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Alcohol abuse&#xD;
&#xD;
          -  Aneurysm clips&#xD;
&#xD;
          -  Pacemaker&#xD;
&#xD;
          -  Neurostimulator&#xD;
&#xD;
          -  Implemented defibrillator&#xD;
&#xD;
          -  Magnetically activated implant or device&#xD;
&#xD;
          -  implemented pump&#xD;
&#xD;
          -  Spinal cord simulator&#xD;
&#xD;
          -  Implemented hearing aid&#xD;
&#xD;
          -  Artificial or prosthetic limb&#xD;
&#xD;
          -  Metal parts in the body&#xD;
&#xD;
          -  Any external or internal metal&#xD;
&#xD;
          -  Artificial heart valve&#xD;
&#xD;
          -  Other implants&#xD;
&#xD;
          -  History of brain surgery&#xD;
&#xD;
          -  Migraine&#xD;
&#xD;
          -  Family history of Epilepsy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>K U Leuven</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>February 2013</verification_date>
  <study_first_submitted>July 24, 2014</study_first_submitted>
  <study_first_submitted_qc>August 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 6, 2014</study_first_posted>
  <last_update_submitted>March 27, 2023</last_update_submitted>
  <last_update_submitted_qc>March 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02210403
org study id: S54797
nct id: NCT02210403
lead sponsor: 
The purpose of this study is to determine whether tDCS in combination with motor training can
      improve hand and arm function in stroke patients.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change of Fugl-Meyer assessment (FMA) score
time frame: Change from baseline in FMA score on the 3rd intervention day; change from baseline in FMA score at 1 week post intervention
measure: Change of Modified Ashworth scale (MAS)
time frame: Change from baseline in MAS scale on the 3rd intervention day; change from baseline in MAS scale at 1 week post intervention
measure: Change of motor task performance
time frame: Change from baseline motor task performance on the 3rd intervention day, and change from baseline in motor task performance at 1 week post intervention
arm group label: Upper limb motor function training + tDCS
arm group type: Active Comparator
description: Bi-hemispheric tDCS with motor function training
arm group label: upper limb motor function training + sham tDCS
arm group type: Sham Comparator
description: sham tDCS with motor function training
intervention type: Device
intervention name: transcranial direct current stimulation (tDCS)
arm group label: Upper limb motor function training + tDCS
arm group label: upper limb motor function training + sham tDCS
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Stroke