Brain Electrical Stimulation to Enhance Recovery After Stroke
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|ClinicalTrials.gov Identifier: NCT00085657|
Recruitment Status : Completed
First Posted : June 11, 2004
Last Update Posted : July 2, 2017
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 or disease|
Show Detailed Description
|Study Type :||Observational|
|Enrollment :||150 participants|
|Official Title:||Enhancement of Rehabilitative Treatment-Dependent Functional Recovery After Stroke by Transcranial Direct Current Stimulation (tDCS)|
|Study Start Date :||June 9, 2004|
|Study Completion Date :||May 21, 2009|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00085657
|United States, District of Columbia|
|National Rehabilitation Hospital Research Center|
|Washington, D.C., District of Columbia, United States|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|