NCT00055588

Nervous System Function in Normal Volunteers During Cycling Training

Completed Phase 1 Last updated 2 July 2017

What this trial tests

Phase 1 trial testing Locomotor training in Healthy in 60 participants. Completed in 20 May 2008.

Timeline

4 March 2003

20 May 2008

Quick facts

Lead sponsor	National Institute of Neurological Disorders and Stroke (NINDS)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Primary purpose	treatment
Enrollment	60
Start date	4 March 2003
Estimated completion	20 May 2008
Sites	1 location across United States

Drugs / interventions tested

• Locomotor training

Conditions studied

• Healthy — all drugs for Healthy →

Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Who can join

18 and older, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.