Nervous System Function in Normal Volunteers During Cycling Training

NCT00055588 | Completed Phase 1

• 2 other identifiers: 03012003-N-0120
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study will identify changes that occur in the nervous system of healthy normal volunteers while they are learning a cycling task. Healthy subjects 18 years of age and older who can cycle for 16 minutes may be eligible for this study. Candidates will be screened with a brief medical history and physical examination. Participants will be assigned to one of three groups:

• Complex training: Cycling for 16 minutes at a constant speed of 60 rpm with frequent changes in pedal resistance.
• Simple training: Cycling for 16 minutes at a constant speed of 60 rpm with no changes in pedal resistance.
• No training: Remaining seated on the bike for 16 minutes performing no exercise. Participants will cycle for 16 minutes for the training task, plus 4 minutes before and after the training. Reflexes will be measured with nerve conduction studies and somatosensory evoked potential (SSEP) recordings before and after training. Nerve conduction studies measure the speed with which nerves conduct electrical impulses and the strength of the connection between the nerve and the muscle. For these studies, a probe is placed on the skin over the calf muscles and the knee to deliver a small electrical stimulus, and wires are taped to the skin to record the impulses. SSEP recordings, which measure of the excitability of the brain to sensory stimuli, are collected from electrodes placed on the scalp. After the training period, multiple train stimulation (MTS) is applied for 10 minutes. For MTS, weak electrical currents are delivered for 10 seconds every 10 seconds. These stimuli produce a buzzing sensation without pain, discomfort, or muscle twitching. The MTS is followed by another 4 minutes of cycling. Participants also undergo transcranial magnetic stimulation (TMS). For this procedure, an insulated wire coil is held over the scalp. A brief electrical current is passed through the coil, creating a magnetic pulse that travels through the scalp and skull and causes small electrical currents in the brain cortex (outer part of the brain). The stimulation may cause twitching in the muscles of the face, arm, or leg. The electrical activity of the muscles is recorded with a computer or other recording device, using electrodes attached to the skin with tape.

Conditions

Healthy

Keywords

Spinal Reflexes; Motor Practice; Spinal Cord Injury; Locomotion; Healthy Volunteer; HV

Interventions

Locomotor training PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Normal volunteers (ages 18 and above) who are willing to participate and who are considered able to cycle for16 minutes based on neurological and physical exams.

You may not qualify if:

• Subjects with history of heart condition, unresponsive arterial hypertension, diabetes, chronic back pain, sciatica, peripheral neuropathy, rheumatoid arthritis, active joint deformity of arthritic origin, alcohol or drug abuse, psychiatric disorder requiring hospitalization or prolonged treatment, head injury with loss of consciousness, epilepsy.
• Subjects with cardiac pace-makers, intracardiac lines, or implanted medication pumps.
• Subjects with history of hyperthyroidism or individuals receiving drugs acting primarily on the central nervous system or disorders of the blood coagulation system.
• Subjects with eye, blood vessel, cochlear, or eye implants.
• Subjects with increased intracranial pressure as evaluated by clinical means.
• Subjects with metal in the cranium except in the mouth.
• Subjects with metal fragments from occupational exposure or surgical clips in or near the brain.
• Women in the last trimester of pregnancy.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

• Boroojerdi B, Ziemann U, Chen R, Butefisch CM, Cohen LG. Mechanisms underlying human motor system plasticity. Muscle Nerve. 2001 May;24(5):602-13. doi: 10.1002/mus.1045.

  PMID: 11317269 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: March 6, 2003
• First Posted: March 6, 2003
• Study Start: March 4, 2003
• Study Completion: May 20, 2008
• Last Updated: July 2, 2017

Record last verified: 2008-05-20

Locations

US (1)