Relationship Between Sensory and Motor Systems in Restless Leg Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00074672
Recruitment Status : Completed
First Posted : December 18, 2003
Last Update Posted : July 2, 2017
Information provided by:
National Institutes of Health Clinical Center (CC)

Brief 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.

Condition or disease
Restless Legs Syndrome

Detailed Description:
Background - Restless leg syndrome (RLS), a condition affecting millions of Americans, is characterized by uncomfortable sensory symptoms relived by voluntary or involuntary movements. Objectives -To test our hypothesis that sensorimotor gating is deficient in RLS. Methods - In a controlled proof-of-principle clinical study, sensorimotor gating will be assessed through the use of validated electrophysiological tests of prepulse inhibition, in 17 adult patients with RLS and 17 matched healthy controls. Risks and benefits -Risks involved in this study are minimal, and deemed reasonable in relation to potential benefits. This investigation will lead to a better understanding of the pathophysiology of RLS.

Study Type : Observational
Enrollment : 45 participants
Official Title: Sensorimotor Gating Studies in Restless Legs Syndrome
Study Start Date : December 12, 2003
Study Completion Date : April 14, 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Restless Legs

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Subjects who meet all of the following inclusion criteria at screening will be eligible to participate in the study:

  1. Male or female subjects aged 18 to 80.
  2. For patients only, diagnosed with primary RLS based on the presence of a characteristic clinical history and the IRLSSG diagnostic criteria.
  3. Normal physical and neurological examination.
  4. Subject is willing to adhere to protocol requirements as evidenced by written, informed consent.
  5. No clinically significant abnormalities on clinical chemistry or hematology examination at the pre-study medical evaluation.
  6. Negative pre-study urine drug screen.


Subjects meeting any of the following exclusion criteria will not be enrolled or will be immediately excluded from the study, as appropriate:

  1. History of any medical condition that can reasonably be expected to compromise scientific integrity of the study;
  2. Patient unwilling or unable to stop their usual mediations for RLS;
  3. Subjects unable or unwilling to discontinue a prohibited concomitant medication
  4. Subjects unwilling to sign an informed consent or to comply with protocol requirements.
  5. Subjects with clinical and/or biological evidence of secondary RLS (e.g. renal failure (end-stage renal disease), iron deficient, anaemia or pregnancy at baseline).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00074672

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)

Publications: Identifier: NCT00074672     History of Changes
Other Study ID Numbers: 040059
First Posted: December 18, 2003    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: April 14, 2009

Keywords provided by National Institutes of Health Clinical Center (CC):
Prepulse Inhibition
Sensorimotor Integration

Additional relevant MeSH terms:
Psychomotor Agitation
Restless Legs Syndrome
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Mental Disorders