Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Transcranial Direct Current Stimulation for Post-stroke Motor Recovery (TRANSPORT 2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03826030
Recruitment Status : Recruiting
First Posted : February 1, 2019
Last Update Posted : May 19, 2020
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date  ICMJE January 30, 2019
First Posted Date  ICMJE February 1, 2019
Last Update Posted Date May 19, 2020
Actual Study Start Date  ICMJE September 1, 2019
Estimated Primary Completion Date November 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2019)
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 ]
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2019)
  • 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 ]
    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).
  • 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 ]
    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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Transcranial Direct Current Stimulation for Post-stroke Motor Recovery
Official Title  ICMJE TRANScranial Direct Current Stimulation for POst-stroke Motor Recovery - a Phase II sTudy (TRANSPORT 2)
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Stroke, Ischemic
  • Motor Activity
  • Upper Extremity Paralysis
Intervention  ICMJE
  • Device: Sham
    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.
  • Device: Low dose tDCS
    The low dose tDCS group receives direct current stimulation at 2 mA for 30 minutes per session
  • Device: High dose tDCS
    The high dose tDCS group receives direct current stimulation at 4 mA for 30 minutes per session
  • Behavioral: mCIMT
    All three tDCS groups receive constraint-induced movement therapy as the adjunctive behavioral therapy for 2 hours per session
Study Arms  ICMJE
  • Sham Comparator: Sham tDCS + mCIMT
    Sham tDCS (Transcranial direct current stimulation) administers no dose or zero milliampere stimulation through the tDCS device, during Constraint Induced Movement Therapy (mCIMT)
    Interventions:
    • Device: Sham
    • Behavioral: mCIMT
  • Active Comparator: 2 mA tDCS + mCIMT
    2 mA tDCS (Transcranial direct current stimulation) administers low dose or 2 milliampere stimulation through the tDCS device, during Constraint Induced Movement Therapy (mCIMT)
    Interventions:
    • Device: Low dose tDCS
    • Behavioral: mCIMT
  • Active Comparator: 4 mA + mCIMT
    4 mA tDCS (Transcranial direct current stimulation) administers high dose or 4 milliampere stimulation through the tDCS device, during Constraint Induced Movement Therapy (mCIMT)
    Interventions:
    • Device: High dose tDCS
    • Behavioral: mCIMT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 30, 2019)
129
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2023
Estimated Primary Completion Date November 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Each subject must meet all of the following criteria to participate in this study:

  1. 18-80 years old; and
  2. First-ever unihemispheric ischemic stroke radiologically verified and occurred within the past 30-180 days; and
  3. >10° of active wrist extension, >10° of thumb abduction/extension, and > 10° of extension in at least 2 additional digits; and
  4. Unilateral limb weakness with a Fugl-Meyer Upper Extremity score of ≤ 54 (out of 66) to avoid ceiling effects; and
  5. An absolute difference of FM-UE scores between the two baseline assessments that is ≤ 2 points indicating stable motor impairment; if subject is not stable, then he/she will be invited for a reassessment after 2 weeks (but no more than 3 reassessments); and
  6. Pre-stroke mRS ≤2; and
  7. Signed informed consent by the subject or Legally Authorized Representative (LAR).

Each Subject who meets any of the following criteria will be excluded from the study:

  1. Primary intracerebral hematoma, subarachnoid hemorrhage or bi-hemispheric or bilateral brainstem ischemic strokes;
  2. Medication use at the time of study that may interfere with tDCS, including but not limited to carbamazepine, flunarizine, sulpiride, rivastigmine, dextromethorphan;
  3. Other co-existent neuromuscular disorders (pre- or post-stroke) affecting upper extremity motor function;
  4. Other neurological disorders (pre- or post-stroke) affecting subject's ability to participate in the study;
  5. Moderate to severe cognitive impairment defined as Montreal Cognitive Assessment (MOCA) score < 20/30;
  6. History of medically uncontrolled depression or other neuro-psychiatric disorders despite medications either before or after stroke that may affect subject's ability to participate in the study;
  7. Uncontrolled hypertension despite medical treatment(s) at the time of randomization, defined as SBP≥185 mmHg or DBP≥110 mmHg (patient can be treated, reassessed and randomized later);
  8. Presence of any MRI/tDCS/TMS risk factors including but not limited to: 8a) an electrically, magnetically or mechanically activated metallic or nonmetallic implant including cardiac pacemaker, intracerebral vascular clips or any other electrically sensitive support system; 8b) a non-fixed metallic part in any part of the body, including a previous metallic injury to eye; 8c) pregnancy (effects of MRI, TMS, and tDCS on the fetus are unknown); 8d) history of seizure disorder or post-stroke seizure; 8e) preexisting scalp lesion under the intended electrode placement or a bone defect or hemicraniectomy;
  9. Planning to move from the local area within the next 6 months;
  10. Life expectancy less than 6 months;
  11. Has received Botulinum toxin injection to the affected upper extremity in the past 3 months prior to randomization or expectation that Botulinum will be given to the Upper Extremity prior to the completion of the last follow-up visit;
  12. Concurrent enrollment in another investigational stroke recovery study;
  13. Doesn't speak sufficient English to comply with study procedures;
  14. Expectation that subject cannot comply with study procedures and visits.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kristina Balderson (919) 684-0071 Kristina.Balderson@duke.edu
Contact: Wayne Feng, MD (919) 681-1700 wayne.feng@duke.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03826030
Other Study ID Numbers  ICMJE Pro00103316
7U01NS102353-02 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan 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.
Time Frame: Please refer to https://nihstrokenet.org/ for detailed information in term of time-frame of sharing such data
Access Criteria: Please refer to https://nihstrokenet.org/ for detailed information in term of time-frame of sharing such data
URL: https://nihstrokenet.org/
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE National Institute of Neurological Disorders and Stroke (NINDS)
Investigators  ICMJE
Principal Investigator: Wayne Feng, MD Duke University
Principal Investigator: Gottfried Schlaug, MD, PhD Beth Israel Deconess Medical Center
PRS Account Duke University
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP