- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00039819
Nerve Stimulation to Modify a Spinal Reflex
Plasticity of Reciprocal Inhibition
This study will determine whether stimulating the nerves or the brain can modify the spinal reflex that controls the muscles that flex and extend the ankle. Training spinal nerve networks with sensory input may provide a way of re-establishing movements, such as walking, in patients with spinal injury.
Healthy normal volunteers with no history of peripheral neuropathy or radiculopathy, ankle contractures or tendon surgery may be eligible for this study. Participants will undergo three stimulation procedures, each in a different session, to measure leg muscle reflexes. The procedures are:
- Reflex testing - Metal electrodes are taped to the skin over the leg muscles. A small electrical pulse is delivered through the electrodes to stimulate two nerves to the muscles. This evokes a reflex between the ankle flexor and extensor muscles. The responses to several dozen stimuli are averaged.
- Nerve stimulation - The nerve to the muscle that flexes the leg is electrically stimulated near the knee through electrodes taped to the skin. The strength of the stimulus is adjusted to produce little or no muscle movement. The stimulation is repeated every few seconds for 45 minutes.
- Transcranial magnetic stimulation - An insulated wire coil is placed on the subject's scalp. A brief electrical current passes through the coil, creating a magnetic pulse that travels through the scalp and skull and causes small electrical currents in the outer part of the brain. There may be twitching in the muscles of the arm or leg. During the stimulation, the subject may be asked to tense certain muscles slightly or perform other simple actions to help determine the best position for the coil over the part of the brain that controls the leg. The leg is then stimulated once every 10 seconds, combined with nerve stimulation every 1 to 2 seconds.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- National Institute of Neurological Disorders and Stroke (NINDS)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
INCLUSION CRITERIA:
Healthy adult volunteers willing to participate
EXCLUSION CRITERIA:
History of peripheral neuropathy or radiculopathy
Implanted devices, including pacemakers, pumps, and defibrillators
Ankle contractures or tendon surgery
Study Plan
How is the study designed?
Collaborators and Investigators
Publications and helpful links
General Publications
- Burke RE. The central pattern generator for locomotion in mammals. Adv Neurol. 2001;87:11-24. No abstract available.
- Wirz M, Colombo G, Dietz V. Long term effects of locomotor training in spinal humans. J Neurol Neurosurg Psychiatry. 2001 Jul;71(1):93-6. doi: 10.1136/jnnp.71.1.93.
- Rossignol S. Locomotion and its recovery after spinal injury. Curr Opin Neurobiol. 2000 Dec;10(6):708-16. doi: 10.1016/s0959-4388(00)00151-3.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 020228
- 02-N-0228
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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