Transcranial Direct Current Stimulation, Improve Functional Motor Recovery, Affected Arm

Stopped early · Not applicable · Has a placebo group

Conditions studied: Brain Infarction, Brain Ischemia

In brief

Overall goal of this study is to determine if transcranial direct current stimulation (tDCS) plus conventional occupational therapy improves functional motor recovery in the affected arm-hand in patients after an acute ischemic stroke compared to sham tDCS plus conventional occupational therapy, and to obtain information to plan a large randomized controlled trial.

Key facts

Study ID

NCT01201629

Run by

University of Oklahoma

People needed

16

Starts

2010-09-16

Expected to finish

2015-12-01

Last updated by the study team

2017-05-10

Who can join

Age: 19 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Unilateral, 1st acute stroke event within 4 weeks of admission to an in-patient rehabilitation facility
• Ischemic stroke documented clinically and by neuroimaging.
• Severe upper limb weakness (MRC grade of 2 or less at the shoulder joint)
• Medically stable from a cardio-respiratory stand point so that they can participate in daily therapies.
• Depressed patients will be included in the study (psychiatrist referral will be made if deemed necessary).
• Aphasic alert patients will be included in the study provided they were able to follow simple directions by verbal or gestural cues and provided with a written informed consent.
• Informed consent, from cognitively intact patients (admission Mini Mental Scale Examination [MMSE] greater than or equal to 21). When it is not possible for the patient to provide informed consent or patient is cognitively impaired with MMSE ≤ 20, proxy consent will be obtained from the next of kin (legal authorized representative) according to institutional IRB standards. Informed consent will be obtained by the admitting physicians.

You may not qualify if…

• Hemorrhagic strokes
• Patient's with an episode post-stroke seizure or history of epilepsy.
• Patients medically unstable, demented, or terminally ill (e.g., patients with stroke as a complication of a terminal cancer).
• On medications such as botox for spasticity or other medications known to enhance motor recovery such as d-amphetamine,
• Stroke patients with implanted pacemakers and defibrillators.
• Refusal to provide informed consent

Where it is running

• Oklahoma City VA Medical Center — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

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