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NCT00074672

Relationship Between Sensory and Motor Systems in Restless Leg Syndrome

Completed Last updated 2 July 2017
What this trial tests

trial in Restless Legs Syndrome in 45 participants. Completed in 14 April 2009.

Timeline
12 December 2003
14 April 2009

Quick facts

Lead sponsorNational Institute of Neurological Disorders and Stroke (NINDS)
StatusCompleted
Study typeOBSERVATIONAL
Enrollment45
Start date12 December 2003
Estimated completion14 April 2009
Sites1 location across United States

Conditions studied

Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Who can join

Adults 18 to 80, any sex, with Restless Legs Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will explore what occurs between sensory and motor systems in restless legs syndrome (RLS). Patients with RLS have uncomfortable sensations in the legs, usually in the evening or early part of the night. Most patients also have periodic involuntary leg movements. The condition tends to worsen over time, resulting in severe discomfort and sleep disturbances. Healthy normal volunteers and patients with RLS between 18 and 80 years of age may be eligible for this study. All candidates will be screened with a medical history, physical and neurological evaluations, electroymogram (measure of muscle activity), overnight sleep study, electrocardiogram (ECG, measurement of the electrical activity of the heart), and blood and urine tests. They may also have brain or spine magnetic resonance imaging (MRI) or computerized tomography (CT) scans and a chest X-ray. Participants must stop taking all medications prohibited by the study for 2 days or more before the study starts and throughout its duration. Participants will undergo prepulse inhibition tests to assess nervous system function. The participant sits comfortably in a quiet room. Several cables are attached to the face and legs using a special cream that conducts electrical signals through the cables to recording equipment. Nervous system activity is evaluated while the subject is at rest and after sensory stimulation (stimulating the nerves in the legs and face with a very brief electrical current of mild to moderate intensity). At times, the subject receives a short, mild sound stimulation delivered through earphones. The testing session takes 4 to 6 hours.

Publications & conference data

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

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Other recruiting trials for Restless Legs Syndrome

Currently open trials in the same condition.

Other National Institute of Neurological Disorders and Stroke (NINDS) trials

Trials by the same sponsor.

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Data sources for this page

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