<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/NCT03826030</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00103316</org_study_id>
    <secondary_id>7U01NS102353-02</secondary_id>
    <nct_id>NCT03826030</nct_id>
  </id_info>
  <brief_title>Transcranial Direct Current Stimulation for Post-stroke Motor Recovery</brief_title>
  <acronym>TRANSPORT 2</acronym>
  <official_title>TRANScranial Direct Current Stimulation for POst-stroke Motor Recovery - a Phase II sTudy (TRANSPORT 2)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Neurological Disorders and Stroke (NINDS)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research study is to find out if brain stimulation at different dosage level combined&#xD;
      with an efficacy-proven rehabilitation therapy can improve arm function. The stimulation&#xD;
      technique is called transcranial direct current stimulation (tDCS). The treatment uses direct&#xD;
      currents to stimulate specific parts of the brain affected by stroke. The adjunctive&#xD;
      rehabilitation therapy is called &quot;modified Constraint-Induced Movement Therapy&quot; (mCIMT).&#xD;
      During this therapy the subject will wear a mitt on the hand of the arm that was not affected&#xD;
      by a stroke and force to use the weak arm. The study will test 3 different doses of brain&#xD;
      stimulation in combination with mCIMT to find out the most promising one.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 1, 2019</start_date>
  <completion_date type="Anticipated">June 2024</completion_date>
  <primary_completion_date type="Anticipated">February 2024</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Change of Motor Impairment as Assessed by Fugl-Meyer Upper-Extremity (FM-UE) scale</measure>
    <time_frame>Baseline through day 15 (after the intervention) and follow-up at day 45 and 105</time_frame>
    <description>The Fugl-Meyer Upper-Extremity (FM-UE) scale is a measure of motor impairment. FM-UE scale consists of a 33-item assessment which provides a global assessment of UE motor impairment. A rater observes 30 voluntary UE motions and 14 voluntary lower extremity (LE) motions, 6 tendon tap responses, and provides an ordinal rating (2=near normal ability/response, 1=partial ability, 0=unable to perform/no response). FM-UE scale is a proven scale with excellent intra-rater reliability (0.99), inter-rater reliability (0.99), test-retest reliability (0.94 -0.99), and internal consistency (0.97).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Change of Functional Motor Activity as assessed by Wolf Motor Function Test (WMFT)</measure>
    <time_frame>Baseline through day 15 (after the intervention) and follow-up at day 45 and 105</time_frame>
    <description>The Wolf Motor Function Test (WMFT) is a measure of functional motor activity that quantifies upper extremity (UE) motor ability through timed and functional tasks. The WMFT consists of approximately 17 functional, strength and movement quality tasks. Each task is rated on a 6 point scale. Lower scores on the 6 point scale indicate lower functioning levels (1 = does not attempt with UE being tested, 2= UE being tested does not participate functionally, but an attempt is made to use the UE, 3= Does attempt but requires assistance of the UE not being tested, requires more than 2 attempts to complete, 4= Does attempt but may lack precision, fine coordination or fluidity, 5= Does attempt, movement similar to non-affected side but slightly slower, and 6= Does attempt and movement appears to be normal).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change of Patient Centered Quality of Life as Assessed by Stroke-Impact-Scale(SIS) hand subscale</measure>
    <time_frame>Baseline through day 15 (after the intervention) and follow-up at day 45 and 105</time_frame>
    <description>The SIS hand subscale assesses how having a stroke impacts a patient's life. The SIS has 8 subscales which ask questions regarding a patient's physical limitations, memory and thinking, emotions and mood, ability to communicate, daily activities, mobility at home and in the community, use of hand most affected by stroke, and ability to participate in meaningful life activities. Each subscale item is rated on a scale from 5-1 (5= None of the time, 4=a little of the time, 3=Some of the time, 2=Most of the time, 1=All of the time)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">129</enrollment>
  <condition>Stroke, Ischemic</condition>
  <condition>Motor Activity</condition>
  <condition>Upper Extremity Paralysis</condition>
  <arm_group>
    <arm_group_label>Sham tDCS + mCIMT</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Sham tDCS (Transcranial direct current stimulation) administers no dose or zero milliampere stimulation through the tDCS device, during Constraint Induced Movement Therapy (mCIMT)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2 mA tDCS + mCIMT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>2 mA tDCS (Transcranial direct current stimulation) administers low dose or 2 milliampere stimulation through the tDCS device, during Constraint Induced Movement Therapy (mCIMT)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>4 mA + mCIMT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>4 mA tDCS (Transcranial direct current stimulation) administers high dose or 4 milliampere stimulation through the tDCS device, during Constraint Induced Movement Therapy (mCIMT)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham</intervention_name>
    <description>sham group receives no active current stimulation except 15 seconds of current ramp up in the beginning and 15 seconds of current ramp up in the end of the 30-minute session to create a scalp perception to blind the subject.</description>
    <arm_group_label>Sham tDCS + mCIMT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Low dose tDCS</intervention_name>
    <description>The low dose tDCS group receives direct current stimulation at 2 mA for 30 minutes per session</description>
    <arm_group_label>2 mA tDCS + mCIMT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>High dose tDCS</intervention_name>
    <description>The high dose tDCS group receives direct current stimulation at 4 mA for 30 minutes per session</description>
    <arm_group_label>4 mA + mCIMT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>mCIMT</intervention_name>
    <description>All three tDCS groups receive constraint-induced movement therapy as the adjunctive behavioral therapy for 2 hours per session</description>
    <arm_group_label>2 mA tDCS + mCIMT</arm_group_label>
    <arm_group_label>4 mA + mCIMT</arm_group_label>
    <arm_group_label>Sham tDCS + mCIMT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Each subject must meet all of the following criteria to participate in this study:&#xD;
&#xD;
          1. 18-80 years old; and&#xD;
&#xD;
          2. First-ever unihemispheric ischemic stroke radiologically verified and occurred within&#xD;
             the past 30-180 days; and&#xD;
&#xD;
          3. &gt;10° of active wrist extension, &gt;10° of thumb abduction/extension, and &gt; 10° of&#xD;
             extension in at least 2 additional digits; and&#xD;
&#xD;
          4. Unilateral limb weakness with a Fugl-Meyer Upper Extremity score of ≤ 54 (out of 66)&#xD;
             to avoid ceiling effects; and&#xD;
&#xD;
          5. An absolute difference of FM-UE scores between the two baseline assessments that is ≤&#xD;
             2 points indicating stable motor impairment; if subject is not stable, then he/she&#xD;
             will be invited for a reassessment after 2 weeks (but no more than 3 reassessments);&#xD;
             and&#xD;
&#xD;
          6. Pre-stroke mRS ≤2; and&#xD;
&#xD;
          7. Signed informed consent by the subject or Legally Authorized Representative (LAR).&#xD;
&#xD;
        Each Subject who meets any of the following criteria will be excluded from the study:&#xD;
&#xD;
          1. Primary intracerebral hematoma, subarachnoid hemorrhage or bi-hemispheric or bilateral&#xD;
             brainstem ischemic strokes;&#xD;
&#xD;
          2. Medication use at the time of study that may interfere with tDCS, including but not&#xD;
             limited to carbamazepine, flunarizine, sulpiride, rivastigmine, dextromethorphan;&#xD;
&#xD;
          3. Other co-existent neuromuscular disorders (pre- or post-stroke) affecting upper&#xD;
             extremity motor function;&#xD;
&#xD;
          4. Other neurological disorders (pre- or post-stroke) affecting subject's ability to&#xD;
             participate in the study;&#xD;
&#xD;
          5. Moderate to severe cognitive impairment defined as Montreal Cognitive Assessment&#xD;
             (MOCA) score &lt; 20/30;&#xD;
&#xD;
          6. History of medically uncontrolled depression or other neuro-psychiatric disorders&#xD;
             despite medications either before or after stroke that may affect subject's ability to&#xD;
             participate in the study;&#xD;
&#xD;
          7. Uncontrolled hypertension despite medical treatment(s) at the time of randomization,&#xD;
             defined as SBP≥185 mmHg or DBP≥110 mmHg (patient can be treated, reassessed and&#xD;
             randomized later);&#xD;
&#xD;
          8. Presence of any MRI/tDCS/TMS risk factors including but not limited to: 8a) an&#xD;
             electrically, magnetically or mechanically activated metallic or nonmetallic implant&#xD;
             including cardiac pacemaker, intracerebral vascular clips or any other electrically&#xD;
             sensitive support system; 8b) a non-fixed metallic part in any part of the body,&#xD;
             including a previous metallic injury to eye; 8c) pregnancy (effects of MRI, TMS, and&#xD;
             tDCS on the fetus are unknown); 8d) history of seizure disorder or post-stroke&#xD;
             seizure; 8e) preexisting scalp lesion under the intended electrode placement or a bone&#xD;
             defect or hemicraniectomy;&#xD;
&#xD;
          9. Planning to move from the local area within the next 6 months;&#xD;
&#xD;
         10. Life expectancy less than 6 months;&#xD;
&#xD;
         11. Has received Botulinum toxin injection to the affected upper extremity in the past 3&#xD;
             months prior to randomization or expectation that Botulinum will be given to the Upper&#xD;
             Extremity prior to the completion of the last follow-up visit;&#xD;
&#xD;
         12. Concurrent enrollment in another investigational stroke recovery study;&#xD;
&#xD;
         13. Doesn't speak sufficient English to comply with study procedures;&#xD;
&#xD;
         14. Expectation that subject cannot comply with study procedures and visits.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wayne Feng, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gottfried Schlaug, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Baystate Health</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Wayne Feng, MD</last_name>
    <phone>(919) 681-1700</phone>
    <email>wayne.feng@duke.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Gottfried Schlaug, MD</last_name>
    <email>Gottfried.Schlaug@baystatehealth.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Alabama</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35249</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tammy Davis</last_name>
      <phone>205-975-8572</phone>
      <email>trdavis@uabmc.edu</email>
    </contact>
    <investigator>
      <last_name>Chen Lin, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of California Los Angeles</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90089</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>MedStar National Rehabilitation Hospital</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Margot Giannetti</last_name>
      <phone>202-877-1071</phone>
      <email>margot.giannetti@medstar.net</email>
    </contact>
    <investigator>
      <last_name>Richard D Zorowitz, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Emory University</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Susan Murphy</last_name>
      <phone>404-712-1928</phone>
      <email>smurph7@emory.edu</email>
    </contact>
    <investigator>
      <last_name>Steve Wolf, PT, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Kentucky</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40504</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Baystate Medical Center</name>
      <address>
        <city>Springfield</city>
        <state>Massachusetts</state>
        <zip>01199</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sirisha Nouduri</last_name>
      <email>Sirisha.Nouduri@baystatehealth.org</email>
    </contact>
    <investigator>
      <last_name>Gottfried Schlaug, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tato Sokhadze, PhD</last_name>
      <phone>919-684-3801</phone>
      <email>estate.sokhadze@duke.edu</email>
    </contact>
    <investigator>
      <last_name>Jody Feld, PhD, PT</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Cincinnati</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Colin Drury</last_name>
      <phone>314-753-5654</phone>
      <email>drurycd@ucmail.uc.edu</email>
    </contact>
    <investigator>
      <last_name>Oluwole Awosika, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cleveland VA Medical Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ahlam Salameh</last_name>
      <phone>330-203-1918</phone>
      <email>ais20@case.edu</email>
    </contact>
    <investigator>
      <last_name>Svetlana Pundik, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Moss Rehabilitation Research Institute</name>
      <address>
        <city>Elkins Park</city>
        <state>Pennsylvania</state>
        <zip>19027</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sapna Kumar</last_name>
      <phone>215-663-6702</phone>
      <email>KumarSap@einstein.edu</email>
    </contact>
    <investigator>
      <last_name>Dylan Edwards, PT,PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ning Cao, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh Medical Center</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amy Boos</last_name>
      <email>amy.boos@pitt.edu</email>
    </contact>
    <contact_backup>
      <last_name>Jason Weimer</last_name>
      <email>weimerjm@upmc.edu</email>
    </contact_backup>
    <investigator>
      <last_name>George Wittenberg, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <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>
    <status>Recruiting</status>
    <contact>
      <last_name>Patricia Finetto</last_name>
      <phone>843-792-8533</phone>
      <email>piersonp@musc.edu</email>
    </contact>
    <investigator>
      <last_name>Chris Gregory, PhD, PT</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Texas Health Science Center / TIRR Memorial Hermann</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Emily Stevens</last_name>
      <phone>713-500-7914</phone>
      <email>emily.a.stevens@uth.tmc.edu</email>
    </contact>
    <investigator>
      <last_name>Gerard Francisco, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>February 7, 2023</last_update_submitted>
  <last_update_submitted_qc>February 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>stroke</keyword>
  <keyword>stroke recovery</keyword>
  <keyword>brain stimulation</keyword>
  <keyword>transcranial direct current stimulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Paralysis</mesh_term>
    <mesh_term>Ischemic Stroke</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>We will follow the National Institute of Health Stroke Trial Network policy and procedure to share IPD. Please refer to https://nihstrokenet.org/ for detailed information.</ipd_description>
    <ipd_time_frame>Please refer to https://nihstrokenet.org/ for detailed information in term of time-frame of sharing such data</ipd_time_frame>
    <ipd_access_criteria>Please refer to https://nihstrokenet.org/ for detailed information in term of time-frame of sharing such data</ipd_access_criteria>
    <ipd_url>https://nihstrokenet.org/</ipd_url>
  </patient_data>
  <!-- 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/NCT03826030
org study id: Pro00103316
secondary id: 7U01NS102353-02
nct id: NCT03826030
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: Yes
This research study is to find out if brain stimulation at different dosage level combined
      with an efficacy-proven rehabilitation therapy can improve arm function. The stimulation
      technique is called transcranial direct current stimulation (tDCS). The treatment uses direct
      currents to stimulate specific parts of the brain affected by stroke. The adjunctive
      rehabilitation therapy is called "modified Constraint-Induced Movement Therapy" (mCIMT).
      During this therapy the subject will wear a mitt on the hand of the arm that was not affected
      by a stroke and force to use the weak arm. The study will test 3 different doses of brain
      stimulation in combination with mCIMT to find out the most promising one.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Mean Change of Motor Impairment as Assessed by Fugl-Meyer Upper-Extremity (FM-UE) scale
time frame: Baseline through day 15 (after the intervention) and follow-up at day 45 and 105
description: The Fugl-Meyer Upper-Extremity (FM-UE) scale is a measure of motor impairment. FM-UE scale consists of a 33-item assessment which provides a global assessment of UE motor impairment. A rater observes 30 voluntary UE motions and 14 voluntary lower extremity (LE) motions, 6 tendon tap responses, and provides an ordinal rating (2=near normal ability/response, 1=partial ability, 0=unable to perform/no response). FM-UE scale is a proven scale with excellent intra-rater reliability (0.99), inter-rater reliability (0.99), test-retest reliability (0.94 -0.99), and internal consistency (0.97).
measure: Mean Change of Functional Motor Activity as assessed by Wolf Motor Function Test (WMFT)
time frame: Baseline through day 15 (after the intervention) and follow-up at day 45 and 105
description: The Wolf Motor Function Test (WMFT) is a measure of functional motor activity that quantifies upper extremity (UE) motor ability through timed and functional tasks. The WMFT consists of approximately 17 functional, strength and movement quality tasks. Each task is rated on a 6 point scale. Lower scores on the 6 point scale indicate lower functioning levels (1 = does not attempt with UE being tested, 2= UE being tested does not participate functionally, but an attempt is made to use the UE, 3= Does attempt but requires assistance of the UE not being tested, requires more than 2 attempts to complete, 4= Does attempt but may lack precision, fine coordination or fluidity, 5= Does attempt, movement similar to non-affected side but slightly slower, and 6= Does attempt and movement appears to be normal).
measure: Mean Change of Patient Centered Quality of Life as Assessed by Stroke-Impact-Scale(SIS) hand subscale
time frame: Baseline through day 15 (after the intervention) and follow-up at day 45 and 105
description: The SIS hand subscale assesses how having a stroke impacts a patient's life. The SIS has 8 subscales which ask questions regarding a patient's physical limitations, memory and thinking, emotions and mood, ability to communicate, daily activities, mobility at home and in the community, use of hand most affected by stroke, and ability to participate in meaningful life activities. Each subscale item is rated on a scale from 5-1 (5= None of the time, 4=a little of the time, 3=Some of the time, 2=Most of the time, 1=All of the time)
arm group label: Sham tDCS + mCIMT
arm group type: Sham Comparator
description: Sham tDCS (Transcranial direct current stimulation) administers no dose or zero milliampere stimulation through the tDCS device, during Constraint Induced Movement Therapy (mCIMT)
arm group label: 2 mA tDCS + mCIMT
arm group type: Active Comparator
description: 2 mA tDCS (Transcranial direct current stimulation) administers low dose or 2 milliampere stimulation through the tDCS device, during Constraint Induced Movement Therapy (mCIMT)
arm group label: 4 mA + mCIMT
arm group type: Active Comparator
description: 4 mA tDCS (Transcranial direct current stimulation) administers high dose or 4 milliampere stimulation through the tDCS device, during Constraint Induced Movement Therapy (mCIMT)
intervention type: Device
intervention name: Sham
description: sham group receives no active current stimulation except 15 seconds of current ramp up in the beginning and 15 seconds of current ramp up in the end of the 30-minute session to create a scalp perception to blind the subject.
arm group label: Sham tDCS + mCIMT
intervention type: Device
intervention name: Low dose tDCS
description: The low dose tDCS group receives direct current stimulation at 2 mA for 30 minutes per session
arm group label: 2 mA tDCS + mCIMT
intervention type: Device
intervention name: High dose tDCS
description: The high dose tDCS group receives direct current stimulation at 4 mA for 30 minutes per session
arm group label: 4 mA + mCIMT
intervention type: Behavioral
intervention name: mCIMT
description: All three tDCS groups receive constraint-induced movement therapy as the adjunctive behavioral therapy for 2 hours per session
arm group label: 2 mA tDCS + mCIMT
arm group label: 4 mA + mCIMT
arm group label: Sham tDCS + mCIMT
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Wayne Feng, MD
role: Principal Investigator
affiliation: Duke University
last name: Gottfried Schlaug, MD, PhD
role: Principal Investigator
affiliation: Baystate Health
last name: Wayne Feng, MD
phone: (919) 681-1700
email: wayne.feng@duke.edu
last name: Gottfried Schlaug, MD
email: Gottfried.Schlaug@baystatehealth.org
facility: 
status: Recruiting
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status: Completed
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country: United States
responsible party type: Sponsor
mesh term: Stroke
mesh term: Paralysis
mesh term: Ischemic Stroke
sharing ipd: Yes
ipd description: We will follow the National Institute of Health Stroke Trial Network policy and procedure to share IPD. Please refer to https://nihstrokenet.org/ for detailed information.
ipd time frame: Please refer to https://nihstrokenet.org/ for detailed information in term of time-frame of sharing such data
ipd access criteria: Please refer to https://nihstrokenet.org/ for detailed information in term of time-frame of sharing such data
ipd url: https://nihstrokenet.org/