Preliminary Study of Transcranial Magnetic Stimulation for Stroke Rehabilitation

NCT00050128 | Completed Phase 1

• 2 other identifiers: 03004903-N-0049
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cerebrovascular Accident

Keywords

Rehabilitation; Plasticity; Frequency; Inhibition; Pinch; Stroke

Interventions

rTMS, Magstim DEVICE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Fifteen adult and impaired patients (right or left) with residual arm function who have had a single monohemispheric ischemic or hemorrhagic stroke (documented by CT or MRI) at least 6 months before, without severe proprioceptive deficits, independent of previous physical therapy will be included.
• They should be able to perform the pinch task.
• All subjects will sign an informed consent prior to participation in the trial.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

• The uses of epidemiology in the study of the elderly. Report of a WHO Scientific Group on the Epidemiology of Aging. World Health Organ Tech Rep Ser. 1984;706:1-84. No abstract available.

  PMID: 6437089 BACKGROUND

MeSH Terms

Conditions

Stroke; Inhibition, Psychological

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 21, 2002
• First Posted: November 22, 2002
• Study Start: November 18, 2002
• Study Completion: October 24, 2007
• Last Updated: July 2, 2017

Record last verified: 2007-10-24

Locations

US (1)