NIH Clinical Research Studies

Protocol Number: 02-N-0104

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Title:
Interhemispheric Interactions Associated with Performance of Voluntary Movements in Patients with Stroke Motor Disability
Number:
02-N-0104
Summary:
This study will use transcranial magnetic stimulation (TMS) to identify interactions between the unaffected and affected side of the brain in stroke patients. Results from previous studies suggest that after a stroke, the motor cortex (part of the brain that controls movement) of the unaffected side of the brain might negatively influence the motor cortex of the affected side. TMS is a procedure that delivers brief electrical currents that stimulate the brain. Studies of a small number of patients have shown that TMS can cause a temporary decrease in activity of the motor cortex.

Healthy normal volunteers and chronic stroke patients may be eligible for this study. Subjects may participate in up to four sessions of reaction time (speed of motor response) testing. They will perform a series of movements with the index and middle fingers of either the left or right hand in response to a signal from a computer monitor. The time it takes to do the tasks will be measured and scored. There will be rest periods during each session.

TMS will be done each session to examine how the motor cortex affects recovery of function after stroke. For this procedure, 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 brain. Depending on where the coil is placed, the stimulation may cause a muscle twitch (sometimes strong enough to move the limb), a feeling of movement or tingling in a limb, or twitching of the jaw. During stimulation, the subject may be asked to tense certain muscles slightly or to perform other simple actions. The electrical activity in the muscles activated by the stimulation will be recorded using metal electrodes taped to the skin over the muscles.

Subjects will also be asked to draw a mark on a line on paper to rate their attention and level of fatigue, and how well they think they are executing the tasks.

Participants will also have magnetic resonance imaging (MRI). This procedure uses a strong magnetic field and radio waves to provide detailed images of the brain. During the scanning, the subject wears earplugs to muffle loud thumping sounds that occur with electrical switching of the radio frequency circuits. The subject can communicate with the staff member performing the study at all times through an intercom system.

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/EXCLUSION CRITERIA - Healthy Volunteers:

Exclusion criteria are contraindications for transcranial magnetic stimulation: pacemaker, implanted medical pump, metal plate in skull, metal objects inside the eye or skull, history of seizures.

Women who are pregnant are excluded from MRI.

INCLUSION CRITERIA - Stroke Patients:

Patients included will be those with only one chronic (more than 6 months) ischemic or hemorrhagic stroke who recovered motor function to the point of being able to perform the motor task required for RT experiments.

EXCLUSION CRITERIA - Stroke Patients:

Patients with more than one stroke.

Patients with brainstem or cerebellar stroke.

Patients with bilateral motor impairment.

Patients or subjects unable to perform the task.

Patients or subjects with history of severe alcohol or drug abuse, psychiatric illness 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 or subjects 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 or subjects with metal in the cranium except mouth.

Patients or subjects with metal fragments from occupational exposure or surgical clips in or near the brain.

Patients or subjects with eye, blood vessel, cochlear or eye implants.

Patients or subjects with increased intracranial pressure as evaluated by clinical means.

Patients with cardiac or neural pacemakers, intracardiac lines and/or implanted medication pumps.

Patients or subjects with history of loss of consciousness or epilepsy.

Patients or subjects with unstable cardiac dysrhythmia.

Patients or subjects with h/o hyperthyroidism.

Patients unable to undergo MRI examination.

Patients or subjects less than 18 or more than 80 years of age.

Women who are pregnant are excluded from MRI.

Special Instructions:
Currently Not Provided
Keywords:
Chronic Stroke
Transcallosal Inhibition
Motor Cortex
Motor Control
Motor Recovery
Recruitment Keyword(s):
Healthy Volunteer
HV
Normal Control
Condition(s):
Cerebrovascular Accident
Healthy
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):
Boroojerdi B, Diefenbach K, Ferbert A. Transcallosal inhibition in cortical and subcortical cerebral vascular lesions. J Neurol Sci. 1996 Dec;144(1-2):160-70.

Bridgers SL, Delaney RC. Transcranial magnetic stimulation: an assessment of cognitive and other cerebral effects. Neurology. 1989 Mar;39(3):417-9.

Chen R, Gerloff C, Hallett M, Cohen LG. Involvement of the ipsilateral motor cortex in finger movements of different complexities. Ann Neurol. 1997 Feb;41(2):247-54.

Active Accrual, Protocols Recruiting New Patients

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