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Enhancement of Use-Dependent Plasticity by Somatosensory Stimulation in Chronic Stroke
This study has been completed.
Study NCT00028379   Information provided by National Institutes of Health Clinical Center (CC)
First Received: December 27, 2001   Last Updated: March 3, 2008   History of Changes

December 27, 2001
March 3, 2008
December 2001
 
 
 
Complete list of historical versions of study NCT00028379 on ClinicalTrials.gov Archive Site
 
 
 
Enhancement of Use-Dependent Plasticity by Somatosensory Stimulation in Chronic Stroke
Enhancement of Use-Dependent Plasticity by Somatosensory Stimulation in Chronic Stroke

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.

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.

 
Interventional
Other
Cerebrovascular Accident
Procedure: Transcranial magnetic stimulation (TMS)
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
52
November 2005
 

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.
Both
 
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00028379
 
020082, 02-N-0082
National Institute of Neurological Disorders and Stroke (NINDS)
 
 
National Institutes of Health Clinical Center (CC)
November 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP