Protocol Number: 04-N-0212

Title:

Enhancement of Rehabilitative Treatment-Dependent Functional Recovery After Stroke by Transcranial Direct Current Stimulation (tDCS)

Number:

04-N-0212

Summary:

This study will examine whether brain stimulation using transcranial direct current stimulation (tDCS) in stroke patients undergoing rehabilitation therapy can help patients recover strength and motor function more than rehabilitation therapy alone. For tDCS, two small metal disks (electrodes) attached to wires are placed on small cotton pads and taped to the subject's head, one on the forehead above the eye and the other on the top of the head. The electrodes deliver a brief electrical current that stimulates the cortex, the part of the brain responsible for motor function.

Adult stroke patients who have weakness on one side of their body as the result of a recent stroke and are receiving rehabilitation therapy at the National Rehabilitation Hospital (NRH) in Washington, D.C., may be eligible for this study Candidates are screened with a physical and neurologic examination, a review of tests done on admission to NRH, and a magnetic resonance imaging (MRI) scan, if one has not been done since the stroke. MRI uses a strong magnetic field and radio waves to obtain images of the brain. The MRI scanner is a metal cylinder surrounded by a strong magnetic field. During the MRI, the patient lies on a table that can slide in and out of the cylinder. Scanning time for this study takes about 30 to 45 minutes.

Participants are randomly assigned to receive tDCS or placebo stimulation, along with rehabilitation therapy, for 2 to 3 weeks, depending on the patient's length of stay at the NRH. For the placebo stimulation, electrodes are placed on the patient's scalp as with tDCS, but no current is delivered. Before and after each rehabilitation session with electrodes, patients undergo Jebsen Taylor motor testing, in which they are asked to lift small objects, turn cards, use a spoon, stack checkers, and lift cans as fast as they can.

On the day of discharge, patients have physical and neurological examinations and the motor function tests described below. The motor tests are repeated, along with standard care and a review of their health status, during outpatient follow-up visits scheduled at 3, 6, 9, and 12 months. The motor tests are:

- Wolf motor function test - Patients are asked to raise a forearm on a table, on a box, to reach across a table, push a sandbag, place a hand on the table, pull a weight, lift a can, pick up a pencil, pick up a paper clip, stack checkers, flip cards, use a key, fold a towel, and pick up a basket.

- Barthel index - Patients are timed for the speed with which they perform certain tasks, such as feeding, grooming, or moving a wheelchair.

- Abilhand questionnaire - Patients answer questions about how they perform routine daily activities.

- GOT test of tactile discrimination - Patients describe objects they feel with their hand.

- Ashworth spasticity scale - A medical staff person moves the patient's arm back and forth to see how stiff it is.

Sponsoring Institute:

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria:

INCLUSION CRITERIA:

We will include patients with subacute thromboembolic non-hemorrhagic subcortical or cortical strokes. Patients will be stratified according to the degree of impairment into a mildly impaired group with initial MRC grade greater than 3 and a severely impaired group with MRC grade less than 3. Assessment of the initial functional state will be taken at the admission at NRH.

EXCLUSION CRITERIA:

Patients with more than one stroke in the medical cerebral artery territory.

Patients with bilateral motor impairment.

Patients with cerebellar or brainstem lesions.

Patients with history of severe alcohol or drug abuse, psychiatric illnesses like severe depression, poor motivational capacity, or severe language disturbances, particularly of receptive nature or with serious cognitive deficits (defined as equivalent to a mini-mental state exam score of 23 or less).

Patients with severe uncontrolled medical problems (e.g. cardiovascular disease, severe rheumatoid arthritis, active joint deformity of arthritic origin, active cancer or renal disease, any kind of end-stage pulmonary or cardiovascular disease, or a deteriorated condition due to age, uncontrolled epilepsy or others).

Patients with increased intracranial pressure as evaluated by clinical means.

Patients with unstable cardiac arrhythmia.

Patients with thyroid disorders.

Patients with more than moderate to severe microangiopathy, polyneuropathy, diabetes mellitus, or ischemic peripheral disease.

Pregnancy.

Special Instructions: Currently Not Provided

Keywords:

Direct Current Stimulation

Cortical Reorganization

Rehabilitation

Acute Stroke

Recruitment Keywords:

Stroke

Conditions:

Investigational Drug(s):

None

Investigational Device(s):

None

Contacts:

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:

Nitsche MA, Paulus W. Excitability changes induced in the human motor cortex by weak transcranial direct currentstimulation. J Physiol. 2000 Sep 15;527 Pt 3:633-9. PMID: 10990547

Jebsen RH, et al. An objective and standardized test of hand function. Arch Phys Med Rehabil. 1969 Jun;50(6):311-9. No abstract available. PMID: 5788487

Hackel ME, et al. Changes in hand function in the aging adult as determined by the Jebsen Test of Hand Function. Phys Ther.1992 May;72(5):373-7. PMID: 1631206

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