TRANSPORT2 - Eligibility -

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Presentation transcript:

TRANSPORT2 - Eligibility - Gottfried Schlaug MD PhD Beth Israel Deaconess Medical Center and Harvard Medical School & Wayne Feng MD MS Medical University of South Carolina

Inclusion Criteria Each subject must meet all of the following criteria to participate in this study: 18-80 years old; First-ever unihemispheric ischemic stroke radiologically verified, occurred within the past 30-180days >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 UE 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 2 weeks (but no more than 3 reassessments); and Pre-stroke mRS ≤2; and Signed informed consent by the subject or Legally Authorized Representative (LAR). Two successive assessment need to be ≤2; Lower cap of FM-UE defined by 10 degree If patient had a clinically silent stroke; it might be ok;

Exclusion Criteria Subjects who meet 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 < 20/30;  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); Neuromuscular: e.g., Mystasthenia, ALS; Myopathies, Spinal cord – MS Other neurological disorders: (e.g., dementia, brain tumors Seizure disorders, neuropsychiatric

Continued….. Presence of any MRI/tDCS/TMS risk factors including but not limited to: a) an electrically, magnetically or mechanically activated metallic or nonmetallic implant including cardiac pacemaker, intracerebral vascular clips or any other electrically sensitive support system; b) a non-fixed metallic part in any part of the body, including a previous metallic injury to eye; c) pregnancy (effects of MRI, TMS, and tDCS on the fetus are unknown); d) history of seizure disorder or post-stroke seizure; e) pre-existing 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.