Brain Electrical Stimulation to Enhance Recovery After Stroke
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Purpose
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.
| Condition |
|---|
|
Stroke |
| Study Type: | Observational |
| Official Title: | Enhancement of Rehabilitative Treatment-Dependent Functional Recovery After Stroke by Transcranial Direct Current Stimulation (tDCS) |
| Estimated Enrollment: | 150 |
| Study Start Date: | June 2004 |
| Estimated Study Completion Date: | May 2009 |
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
- 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:
- Patients with more than one stroke in the medial 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.
- Patients with metallic implants in the head.
- Patients with pacemakers.
- Patients taking antiadrenergic medications.
- 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
- 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.
Contacts and Locations| United States, District of Columbia | |
| National Rehabilitation Hospital Research Center | |
| Washington, District of Columbia, United States | |
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | |
| Bethesda, Maryland, United States, 20892 | |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00085657 History of Changes |
| Other Study ID Numbers: | 040212, 04-N-0212 |
| Study First Received: | June 10, 2004 |
| Last Updated: | May 22, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institutes of Health Clinical Center (CC):
|
Direct Current Stimulation Cortical Reorganization Rehabilitation Acute Stroke Stroke |
Additional relevant MeSH terms:
|
Stroke Cerebral Infarction Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia |
ClinicalTrials.gov processed this record on May 23, 2013