Relationship Between Sensory and Motor Systems in Restless Leg Syndrome

NCT00074672 | Completed

• 2 other identifiers: 04005904-N-0059
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Restless Legs Syndrome

Keywords

Prepulse Inhibition; PPI; Dopamine; Sensorimotor Integration; Dopaminergic

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• History of any medical condition that can reasonably be expected to compromise scientific integrity of the study;
• Patient unwilling or unable to stop their usual mediations for RLS;
• Subjects unable or unwilling to discontinue a prohibited concomitant medication
• Subjects unwilling to sign an informed consent or to comply with protocol requirements.
• 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).

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Walters AS. Toward a better definition of the restless legs syndrome. The International Restless Legs Syndrome Study Group. Mov Disord. 1995 Sep;10(5):634-42. doi: 10.1002/mds.870100517.

  PMID: 8552117 BACKGROUND

• Silber MH. Restless legs syndrome. Mayo Clin Proc. 1997 Mar;72(3):261-4. doi: 10.4065/72.3.261.

  PMID: 9070203 BACKGROUND

• Ondo W, Jankovic J. Restless legs syndrome: clinicoetiologic correlates. Neurology. 1996 Dec;47(6):1435-41. doi: 10.1212/wnl.47.6.1435.

  PMID: 8960723 BACKGROUND

MeSH Terms

Conditions

Restless Legs Syndrome

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: December 17, 2003
• First Posted: December 18, 2003
• Study Start: December 12, 2003
• Study Completion: April 14, 2009
• Last Updated: July 2, 2017

Record last verified: 2009-04-14

Locations

US (1)