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

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ClinicalTrials.gov Identifier: NCT03826030
Recruitment Status : Recruiting
First Posted : February 1, 2019
Last Update Posted : September 4, 2019
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Wuwei Feng, Medical University of South Carolina

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.

Condition or disease Intervention/treatment Phase
Stroke, Ischemic Motor Activity Upper Extremity Paralysis Device: Sham Device: Low dose tDCS Device: High dose tDCS Behavioral: mCIMT Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 129 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: TRANScranial Direct Current Stimulation for POst-stroke Motor Recovery - a Phase II sTudy (TRANSPORT 2)
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : January 2023

Arm Intervention/treatment
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)
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.

Behavioral: mCIMT
All three tDCS groups receive constraint-induced movement therapy as the adjunctive behavioral therapy for 2 hours per session

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)
Device: Low dose tDCS
The low dose tDCS group receives direct current stimulation at 2 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

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)
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




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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)



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03826030


Contacts
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Contact: Kelly Krajeck, BS 843-792-0189 krajeck@musc.edu
Contact: Wayne Feng, MD 843-792-9826 feng@musc.edu

Locations
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United States, Alabama
University of Alabama Not yet recruiting
Birmingham, Alabama, United States, 35249
Contact: Tammy Davis, RN    205-975-8572    trdavis@uabmc.edu   
Principal Investigator: Chen Lin, MD         
United States, California
University of California Los Angeles Not yet recruiting
Los Angeles, California, United States, 90089
Contact: Clare Binley, RN    323-409-1532    clare.binley@med.usc.edu   
Principal Investigator: Beth Fisher, PT, PhD         
United States, District of Columbia
MedStar National Rehabilitation Hospital Not yet recruiting
Washington, District of Columbia, United States, 20010
Contact: Juby Mathews    202-877-1544    juby.t.mathews@medstar.net   
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Susan Murphy    404-712-1928    smurph7@emory.edu   
Principal Investigator: Steve Wolf, PT, PhD         
United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40504
Contact: Elizabeth Powell    859-323-6889    elizabeth.salmon@uky.edu   
Principal Investigator: Lumy Sawaki Adams, MD,PhD         
United States, Missouri
Barnes Jewish Hospital Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Jenny Babka       babkaj@wustl.edu   
Principal Investigator: Catherine Lang, PT,PhD         
United States, New York
Burke Rehabilitation Institute Recruiting
White Plains, New York, United States, 10605
Contact: Joshua Silverstein    914-368-3185    jos3008@med.cornell.edu   
Principal Investigator: Tomoko Kitago, MD         
United States, Ohio
University of Cincinnati Not yet recruiting
Cincinnati, Ohio, United States, 45219
Contact: Emily Staggs    513-558-7656    staggsej@ucmail.uc.edu   
Principal Investigator: Oluwole Awosika, MD         
United States, Pennsylvania
Moss Rehabilitation Research Institute Recruiting
Elkins Park, Pennsylvania, United States, 19027
Contact: Dylan Edwards, PT,PhD         
Principal Investigator: Dylan Edwards, PT,PhD         
Principal Investigator: Ning Cao, MD         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Kelly Krajeck, BS    843-792-0189    krajeck@musc.edu   
Principal Investigator: Michelle Woodbury, PhD,OTR/L         
United States, Texas
Texas Medical Center Not yet recruiting
Houston, Texas, United States, 77030
Contact: Dory Parker    713-500-7085    Dorothea.M.Parker@uth.tmc.edu   
Principal Investigator: Sheng Li, MD         
Sponsors and Collaborators
Medical University of South Carolina
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
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Principal Investigator: Wayne Feng, MD Medical University of South Carolina
Principal Investigator: Gottfried Schlaug, MD, PhD Beth Israel Deconess Medical Center

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Responsible Party: Wuwei Feng, Professor of Neurology, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT03826030     History of Changes
Other Study ID Numbers: 2018-4092
1U01NS102353-01A1 ( U.S. NIH Grant/Contract )
00083043 ( Other Identifier: Medical University of SC )
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
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/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wuwei Feng, Medical University of South Carolina:
stroke
stroke recovery
brain stimulation
transcranial direct current stimulation
Additional relevant MeSH terms:
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Stroke
Paralysis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations
Signs and Symptoms