CompletedPhase 2

Transcranial Direct Current Stimulation for Post-stroke Motor Recovery

United States129 participantsStarted 2019-09-01

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 7-14 days (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 Mo…

What they're measuring

Mean Change in FM-UE From Baseline

Timeframe: Day 15

Trial details

NCT IDNCT03826030

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-19

Results submitted2025-07-10