Preliminary Study of Transcranial Magnetic Stimulation for Stroke Rehabilitation
Completed · Phase 1
Conditions studied: Cerebrovascular Accident
In brief
This is a preliminary study to evaluate the possible use of transcranial magnetic stimulation (TMS), together with exercise, for rehabilitation of chronic stroke patients. It will identify the optimum stimulation settings (within the limits of current safety guidelines) to be used in a later rehabilitation study and confirm the safety of the procedure at these settings. Some previous studies using TMS to treat movement disorders such as Parkinson's disease have shown improvement in motor function; others have not. The results of this study may provide information to help researchers design better rehabilitation treatments after stroke. Stroke patients with residual arm function and no history of seizures may be eligible for this study. The stroke must have occurred at least 6 months before entry into the study and must have affected only one side of the brain. For the TMS procedure, subjects are seated in a comfortable chair with their hands placed on a pillow on their lap. An insulated wire coil is placed on the scalp. A brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the outer part of the brain, called the cortex. This may cause muscle, hand or arm twitching if the coil is near the part of the brain that controls movement, or it may affect movements or reflexes. Subjects are asked to make movements, do simple tasks, or tense muscles. Metal electrodes are taped to the skin over the muscle for computer recording of the electrical activity of the hand and arm muscles activated by the stimulation. The testing lasts 2-3 hours.
Key facts
- Study ID
- NCT00050128
- Run by
- National Institute of Neurological Disorders and Stroke (NINDS)
- People needed
- 15
- Starts
- 2002-11-18
- Expected to finish
- 2007-10-24
- Last updated by the study team
- 2017-07-02
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Exclusion criteria for the trial will include any current actively treated medical or surgical condition or neurological or psychiatric illness other than stroke.
- Any individual who is on medication which is known to lower seizure threshold, or who has a pacemaker, an implanted medical pump, a metal plate, a metal plate or metal object in the skull or eye (for example after brain surgery) will be excluded.
- Additional exclusion include patients with:
- History of more than one stroke;
- Large cortical, cerebellar, or brainstem lesions;
- An inability to extend metacarpophalangeal (MP) joints at least 10-20 degrees;
- Substantially recovered motor function;
- Severe depression;
- Poor motivational capacity, or severe language disturbances (particularly of receptive nature);
- Severe spasticity/pain;
- Bilateral motor problems;
- Serious cognitive deficits (defined as equivalent to a mini-mental state exam score of 20 or less);
- Uncontrolled medical problems, such as: cardiopulmonary disease, severe rheumatoid arthritis, active joint deformity of arthritic origin, active cancer, or renal disease;
- Uncontrollable issues due to natural aging;
- History of seizure(s).
- All patients will underfo electroencephalogram (EEG) examination prior to rTMS experiment as a part of the screening procedure.
- Patients without any history of seizures, but with any sign of increased cerebral activity in the EEG will be excluded.
- Women who are pregnant may not participate and women who are of childbearing years must be post-menopausal, sterile, or practicing adequate birth control.
- Children will be excluded.
Where it is running
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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