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NCT00074672 · ClinicalTrials.gov registry record

Relationship Between Sensory and Motor Systems in Restless Leg Syndrome

A clinical trial, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).

Completed
Registry status
45
Enrollment target

NCT00074672: Completed study, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).

NCT00074672 is a clinical trial that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 45 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00074672 has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).

COMPLETED
Registry status
45 participants
Enrollment target

Study 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.

Trial Details

FieldValue
Enrollment Target 45 participants
Start Date 2003-12-12
Est. Completion 2009-04-14

What the finished NCT00074672 record still lists

NCT00074672 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 45 participants, a relatively small participant target.

The record links to 0 conditions, and to 0 interventions.

NCT00074672 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00074672 about?

NCT00074672 is a clinical study titled "Relationship Between Sensory and Motor Systems in Restless Leg Syndrome". 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 wo...

What is the current status of trial NCT00074672?

This trial is currently completed. The enrollment target is 45 participants. The study started on 2003-12-12. Estimated completion is 2009-04-14.

Who is sponsoring clinical trial NCT00074672?

This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT00074672, the US trial registry maintained by the National Library of Medicine. NCT00074672 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.