Status:
COMPLETED
Transcranial Direct Current Stimulation for Post-stroke Motor Recovery
Lead Sponsor:
Duke University
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Stroke, Ischemic
Motor Activity
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- Each subject must meet all of the following criteria to participate in this study:
- 18-80 years old; and
- First-ever unihemispheric ischemic stroke radiologically verified and occurred within the past 30-180 days; and
- \>10° of active wrist extension, \>10° of thumb abduction/extension, and \> 10° of extension in at least 2 additional digits; and
- Unilateral limb weakness with a Fugl-Meyer Upper Extremity score of ≤ 54 (out of 66) to avoid ceiling effects; and
- 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 7-14 days (but no more than 3 reassessments); and
- Pre-stroke mRS ≤2; and
- 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:
- Primary intracerebral hematoma, subarachnoid hemorrhage or bi-hemispheric or bilateral brainstem ischemic strokes;
- Medication use at the time of study that may interfere with tDCS, including but not limited to carbamazepine, flunarizine, sulpiride, rivastigmine, dextromethorphan;
- Other co-existent neuromuscular disorders (pre- or post-stroke) affecting upper extremity motor function;
- Other neurological disorders (pre- or post-stroke) affecting subject's ability to participate in the study;
- Moderate to severe cognitive impairment defined as Montreal Cognitive Assessment (MOCA) score \< 18/30;
- 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;
- 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);
- 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;
- Planning to move from the local area within the next 6 months;
- Life expectancy less than 6 months;
- 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;
- Concurrent enrollment in another investigational stroke recovery study;
- Doesn't speak sufficient English to comply with study procedures;
- Expectation that subject cannot comply with study procedures and visits.
Exclusion
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 19 2024
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT03826030
Start Date
September 1 2019
End Date
September 19 2024
Last Update
August 22 2025
Active Locations (14)
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1
University of Alabama at Birmingham Hospital
Birmingham, Alabama, United States, 35249
2
Keck Hospital of USC
Los Angeles, California, United States, 90089
3
MedStar National Rehabilitation Hospital
Washington D.C., District of Columbia, United States, 20010
4
Emory Rehabilitation Hospital
Atlanta, Georgia, United States, 30322