Enhancement of Use-Dependent Plasticity by Somatosensory Stimulation in Chronic Stroke
2 other identifiers
interventional
52
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2001
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2001
CompletedFirst Submitted
Initial submission to the registry
December 27, 2001
CompletedFirst Posted
Study publicly available on registry
December 28, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2005
CompletedMarch 4, 2008
November 1, 2005
December 27, 2001
March 3, 2008
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, 20892, United States
Related Publications (3)
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. doi: 10.1007/s002210000562.
PMID: 11243475BACKGROUNDBarker 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. doi: 10.1097/00006123-198701000-00024.
PMID: 3808249BACKGROUNDBarker AT, Jalinous R, Freeston IL. Non-invasive magnetic stimulation of human motor cortex. Lancet. 1985 May 11;1(8437):1106-7. doi: 10.1016/s0140-6736(85)92413-4. No abstract available.
PMID: 2860322BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Sponsor Type
- NIH
Study Record Dates
First Submitted
December 27, 2001
First Posted
December 28, 2001
Study Start
December 1, 2001
Study Completion
November 1, 2005
Last Updated
March 4, 2008
Record last verified: 2005-11