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



Status:Terminated
Conditions:Peripheral Vascular Disease, Neurology
Therapuetic Areas:Cardiology / Vascular Diseases, Neurology
Healthy:No
Age Range:19 - 90
Updated:4/21/2016
Start Date:January 2009
End Date:December 2015

Use our guide to learn which trials are right for you!

Does Transcranial Direct Current Stimulation Improve Functional Motor Recovery in the Affected Arm-Hand in Patients After an Acute Ischemic Stroke: A Randomized Control Trial

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.

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

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
We found this trial at
1
site
Oklahoma City, Oklahoma 73104
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials