NCT00039819

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2002

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

June 1, 2002

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

June 11, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 12, 2002

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2003

Completed
Last Updated

March 4, 2008

Status Verified

May 1, 2003

First QC Date

June 11, 2002

Last Update Submit

March 3, 2008

Conditions

Keywords

Spinal CordSensory StimulationLocomotionMagnetic StimulationReflexesHealthy VolunteerHVNormal Control

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy adult volunteers willing to participate

You may not qualify if:

  • History of peripheral neuropathy or radiculopathy
  • Implanted devices, including pacemakers, pumps, and defibrillators
  • Ankle contractures or tendon surgery

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

Location

Related Publications (3)

  • Burke RE. The central pattern generator for locomotion in mammals. Adv Neurol. 2001;87:11-24. No abstract available.

    PMID: 11347213BACKGROUND
  • 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.

    PMID: 11413270BACKGROUND
  • 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.

    PMID: 11240279BACKGROUND

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

June 11, 2002

First Posted

June 12, 2002

Study Start

June 1, 2002

Study Completion

May 1, 2003

Last Updated

March 4, 2008

Record last verified: 2003-05

Locations