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N/ACompleted
Drug / intervention
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Likely dose
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Search/NCT00074672
NCT00074672N/ACompleted

Sensorimotor Gating Studies in Restless Legs Syndrome

National Institute of Neurological Disorders and Stroke (NINDS)·observational·Posted Dec 18, 2003·Updated Jul 2, 2017

In Brief

An observational study for Restless Legs Syndrome. Completed, across 1 site.

Detailed Summary

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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 18, 2003
Enrollment StartDec 12, 2003
Study CompletionApr 14, 2009
TodayJul 2, 2026
Posted 22.5 years ago