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Nerve Stimulation to Modify a Spinal Reflex
This study has been completed.
First Received: June 11, 2002   Last Updated: March 3, 2008   History of Changes
Sponsored by: National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00039819
  Purpose

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.

Condition
Healthy

U.S. FDA Resources
Study Type: Observational
Official Title: Plasticity of Reciprocal Inhibition

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

Estimated Enrollment: 25
Study Start Date: June 2002
Estimated Study Completion Date: May 2003
Detailed Description:

Training of spinal interneuronal networks may offer a means for re-establishing movements such as locomotion in patients with spinal injury. Sensory feedback in the pattern which results from the leg movement is hypothesized to be the critical component for training spinal networks. This protocol will address the basic assumption underlying such training: can a specific pattern of sensory input modify the strength of a spinal cord circuit? We will test whether peripheral nerve stimulation can modify the strength of the spinal reflex mediating reciprocal inhibition between ankle flexor and extensor muscles in normal subjects, comparing patterned and unpatterned stimulation.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00039819

Locations
United States, Maryland
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
Study ID Numbers: 020228, 02-N-0228
Study First Received: June 11, 2002
Last Updated: March 3, 2008
ClinicalTrials.gov Identifier: NCT00039819     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Spinal Cord
Sensory Stimulation
Locomotion
Magnetic Stimulation
Reflexes
Healthy Volunteer
HV
Normal Control

Study placed in the following topic categories:
Healthy

ClinicalTrials.gov processed this record on May 07, 2009