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 patients who have weakness on one side of their body as a result of a stroke occurred within the last 15 days may be eligible for this study. NIH is not directly recruiting patients for this study. Patients will be selected through the National Rehabilitation Hospital (NRH) Research Center personnel in Washington, DC, from patients under treatment at that facilitiy. 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, 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: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria:

INCLUSION CRITERIA:

We will include patients aged 18-80 years old with subacute thromboembolic non-hemorrhagic subcortical or cortical strokes stratified according to the degree of impairment into mildly impaired (MRC greater than 3) and severely impaired (MRC less than 3). Assessment of the initial functional state will be taken at the admission at NRH. For healthy volunteers, subjects with a normal physical and neurological examination could participate.

EXCLUSION CRITERIA:

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

2. Patients with bilateral motor impairment.

3. Patients with cerebellar or brainstem lesions.

4. 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).

5. 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).

6. Patients with increased intracranial pressure as evaluated by clinical means.

7. Patients with unstable cardiac arrhythmia.

8. Patients with thyroid disorders.

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

10. Pregnancy.

11. Patients with metallic implants in the head.

12. Patients with pacemakers.

13. Patients taking antiadrenergic medications.

14. For fMRI: 1) Medical or technical contraindications to MRI procedures (e.g. metal braces, pacemakers, cochlear devices, surgical clips, and other metal/magnetic implants); 2) Claustrophobia; 3) inability to comply with the protocol 4) pregnancy (a urine pregnancy test will be performed for premenopausal females prior to MRI). All other criteria stated above will also apply

15. For TMS: 1) Seizure disorder; 2) Metallic implant in the head; 3) Pacemaker; 4) Unable to perform the task; 5) Pregnant or breast feeding a child; 6) Patients or subjects with increased intracranial pressure as evaluated by clinical means. All other criteria stated above will also apply.

For healthy volunteers, subjects with stroke(s) or movement disorder(s); history of alcohol or drug abuse or a psychiatric illness like depression, other major medical problems that effect heart, lungs or kidneys or epilepsy or diabetes mellitus; thyroid gland problem; other diseases of the brain, like Alzheimer's disease; medical or technical contraindications to MRI procedures (e.g. metal braces, pacemakers, cochlear devices, surgical clips, and other metal/magnetic implants); claustrophobia; pregnant or breast feeding women could not participate.

Special Instructions:

Currently Not Provided

Keywords:

Direct Current Stimulation

Cortical Reorganization

Rehabilitation

Acute Stroke

Recruitment Keyword(s):

Stroke

Condition(s):

Stroke

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Institute of Neurological Disorders and Stroke

Contact(s):

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

Citation(s):

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.

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.

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.

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