Enhancement of Use-Dependent Plasticity by Somatosensory Stimulation in Chronic Stroke - Full Text View

Purpose

Recent studies have demonstrated that electrical stimulation delivered over the skin increases the muscle strength as measured by a dynamometer in chronic stroke patients. We recently also found out that such stimulation enhances the ability of healthy brains to learn faster, enhancing the beneficial effects of the motor training.

The purpose of this study is to find out if this stimulation can enhance the ability of stroke patients to experience plastic changes in the brain. It may aid in the development of new strategies for rehabilitation after brain injury in the future.

A clinical and neurological exam will be administered. Each patient will participate in three different sessions separated by at least 48 hours: a 2-hour peripheral nerve stimulation to the weak hand, a 2-hour peripheral nerve stimulation to the leg, and no stimulation. The sessions will be randomly ordered. A magnetic resonance imaging scan of the brain will be done as well.

Nerve stimulation will be done by transcranial magnetic stimulation (TMS). In TMS, the head is immobilized within a frame. An insulated coil wire is placed on the scalp and brief electrical current passed through it. Participants may be asked to perform movements, do simple tasks, or simply tense muscles. Electrical activity of the muscles will be recorded with a computer. Some experiments may be recorded on videotape.

Participants must be stroke patients who have recovered to the point of being able to make thumb movements, and the stroke must have occurred more than 6 months ago.

Condition	Intervention
Cerebrovascular Accident	Procedure: Transcranial magnetic stimulation (TMS)

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Other

Official Title:	Enhancement of Use-Dependent Plasticity by Somatosensory Stimulation in Chronic Stroke

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment:	52
Study Start Date:	December 2001
Estimated Study Completion Date:	November 2005

Detailed Description:

There are very few therapeutic options for the treatment of motor disabilities resulting from chronic stroke. Motor training results in use-dependent plasticity, thought to underlie recovery of motor function after cortical lesions. We recently demonstrated that stimulation of peripheral nerves (SPN) administered in association with motor training enhances use-dependent plasticity in healthy volunteers. The purpose of this protocol is to investigate if SPN administered in association with motor training enhances use-dependent plasticity in patients with chronic stroke. If so, it may become an important tool to enhance the beneficial effects of rehabilitative treatment in this patient group.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

INCLUSION CRITERIA:

Hemiparetic patients (right or left who had thromboembolic non-hemorrhagic infarction (documented by CT or MRI) more than 6 months before. Patients should have recovered motor function to the point of being able to perform thumb movements.

Patients will be recruited from referrals from the community, particularly Baltimore and Washington VA hospitals, and Suburban Hospital as well as stroke clubs. An anatomical MRI scan will be acquired at the NIH if a recent one (within 6 months) is not available.

EXCLUSION CRITERIA:

Large hemorrhagic or brain stem stroke.
Multiple cerebral lesions with residual deficits.
History of head injury with loss of consciousness.
History of severe alcohol or drug abuse.
History of psychiatric illness.
Unstable cardiac dysrhythmia or unresponsive arterial hypertension (greater than 160/100 mmHg).
H/o hyperthyroidism.
Receiving alpha-adrenergic antagonists or agonists, major/minor tranquilizers, clonidine,prazosin, phenytoin, benzodiazepines, scopolamine, haloperidol, other neuroleptics, barbiturates.
Degree of aphasia or cognitive deficit that makes patient unable to give informed consent.
Pregnancy, glaucoma, h/o hypersensitivity or idiosyncrasy to sympatomimetic drugs.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00028379

Locations


United States, Maryland
	National Institute of Neurological Disorders and Stroke (NINDS)
	Bethesda, Maryland, United States, 20892

Sponsors and Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

More Information

Publications:

Aschersleben G, Gehrke J, Prinz W. Tapping with peripheral nerve block. a role for tactile feedback in the timing of movements. Exp Brain Res. 2001 Feb;136(3):331-9.

Barker AT, Freeston IL, Jalinous R, Jarratt JA. Magnetic stimulation of the human brain and peripheral nervous system: an introduction and the results of an initial clinical evaluation. Neurosurgery. 1987 Jan;20(1):100-9.

Barker AT, Jalinous R, Freeston IL. Non-invasive magnetic stimulation of human motor cortex. Lancet. 1985 May 11;1(8437):1106-7. No abstract available.

Study ID Numbers:	020082, 02-N-0082
First Received:	December 27, 2001
Last Updated:	March 3, 2008
ClinicalTrials.gov Identifier:	NCT00028379
Health Authority:	United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):

Plasticity

Motor Cortex

Stroke

Somatosensory

Stroke

Hemiparesis

Study placed in the following topic categories:

Cerebral Infarction

Stroke

Vascular Diseases

Central Nervous System Diseases

Brain Ischemia

Ischemia

Brain Infarction

Brain Diseases

Infarction

Cerebrovascular Disorders

Additional relevant MeSH terms:

Nervous System Diseases

Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 21, 2008

Sponsored by:	National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by:	National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:	NCT00028379