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

Terminated

Phase 2 Results N/A

Update History

20 Feb '16
A location was updated in Oklahoma City.
New
The overall status was removed for Oklahoma City VA Medical Center.
5 Dec '14
Trial name was updated.
New
Transcranial Direct Current Stimulation, Improve Functional Motor Recovery, Affected Arm
6 Oct '11
The description was updated.
New
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 criteria: 1. Unilateral, 1st acute stroke event within 4 weeks of admission to an in-patient rehabilitation facility 2. Ischemic stroke documented clinically and by neuroimaging. 3. Severe upper limb weakness (MRC grade of 2 or less at the shoulder joint) 4. Medically stable from a cardio-respiratory stand point so that they can participate in daily therapies. 5. Depressed patients will be included in the study (psychiatrist referral will be made if deemed necessary). 6. 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. 7. 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 criteria: 1. Hemorrhagic strokes 2. Patient's with an episode post-stroke seizure or history of epilepsy. 3. Patients medically unstable, demented, or terminally ill (e.g., patients with stroke as a complication of a terminal cancer). 4. On medications such as botox for spasticity or other medications known to enhance motor recovery such as d-amphetamine, 5. Stroke patients with implanted pacemakers and defibrillators. 6. Refusal to provide informed consent
Old
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 criteria: 1. Unilateral, 1st acute stroke event within 4 weeks of admission to an in-patient rehabilitation facility 2. Ischemic stroke documented clinically and by neuroimaging. 3. Severe upper limb weakness (MRC grade of 2 or less at the shoulder joint) 4. Medically stable from a cardio-respiratory stand point so that they can participate in daily therapies. 5. Depressed patients will be included in the study (psychiatrist referral will be made if deemed necessary). 6. 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. 7. 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 criteria: 1. Hemorrhagic strokes 2. Patient's with an episode post-stroke seizure or history of epilepsy. 3. Patients medically unstable, demented, or terminally ill (e.g., patients with stroke as a complication of a terminal cancer). 4. On medications such as botox for spasticity or other medications known to enhance motor recovery such as d-amphetamine, 5. Stroke patients with implanted pacemakers and defibrillators. 6. Refusal to provide informed consent
The eligibility criteria were updated.
New
Inclusion Criteria: 1. Unilateral, 1st acute stroke event within 4 weeks of admission to an in-patient rehabilitation facility 2. Ischemic stroke documented clinically and by neuroimaging. 3. Severe upper limb weakness (MRC grade of 2 or less at the shoulder joint) 4. Medically stable from a cardio-respiratory stand point so that they can participate in daily therapies. 5. Depressed patients will be included in the study (psychiatrist referral will be made if deemed necessary). 6. 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. 7. 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 Criteria: 1. Hemorrhagic strokes 2. Patient's with an episode post-stroke seizure or history of epilepsy. 3. Patients medically unstable, demented, or terminally ill (e.g., patients with stroke as a complication of a terminal cancer). 4. On medications such as botox for spasticity or other medications known to enhance motor recovery such as d-amphetamine, 5. Stroke patients with implanted pacemakers and defibrillators. 6. Refusal to provide informed consent
Old
Inclusion Criteria: 1. Unilateral, 1st acute stroke event within 4 weeks of admission to an in-patient rehabilitation facility 2. Ischemic stroke documented clinically and by neuroimaging. 3. Severe upper limb weakness (MRC grade of 2 or less at the shoulder joint) 4. Medically stable from a cardio-respiratory stand point so that they can participate in daily therapies. 5. Depressed patients will be included in the study (psychiatrist referral will be made if deemed necessary). 6. 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. 7. 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 Criteria: 1. Hemorrhagic strokes 2. Patient's with an episode post-stroke seizure or history of epilepsy. 3. Patients medically unstable, demented, or terminally ill (e.g., patients with stroke as a complication of a terminal cancer). 4. On medications such as botox for spasticity or other medications known to enhance motor recovery such as d-amphetamine, 5. Stroke patients with implanted pacemakers and defibrillators. 6. Refusal to provide informed consent