Status:
TERMINATED
Transcranial Direct Current Stimulation, Improve Functional Motor Recovery, Affected Arm
Lead Sponsor:
University of Oklahoma
Collaborating Sponsors:
VA Office of Research and Development
Conditions:
Brain Infarction
Brain Ischemia
Eligibility:
All Genders
19-90 years
Phase:
NA
Brief Summary
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 patie...
Detailed Description
Study design: Patients Successive admissions to the stroke service of the Veterans Affairs Medical Center with ischemic strokes will participate in this study. Eligibility criteria: Inclusion crite...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
September 16 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01201629
Start Date
September 16 2010
End Date
December 1 2015
Last Update
May 10 2017
Active Locations (1)
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1
Oklahoma City VA Medical Center
Oklahoma City, Oklahoma, United States, 73104