Completed

Sensorimotor Gating Studies in Restless Legs Syndrome

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What is being collected

Data Collection

Who is being recruted

Aberrant Motor Behavior in Dementia+14

+ Mental Disorders

+ Behavioral Symptoms

From 18 to 80 Years
See all eligibility criteria
How is the trial designed

Observational
Study Start: December 2003
See protocol details

Summary

Principal SponsorNational Institute of Neurological Disorders and Stroke (NINDS)
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 12, 2003

Actual date on which the first participant was enrolled.

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.

Official TitleSensorimotor Gating Studies in Restless Legs Syndrome 
NCT00074672
Principal SponsorNational Institute of Neurological Disorders and Stroke (NINDS)
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

45 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Aberrant Motor Behavior in DementiaMental DisordersBehavioral SymptomsDiseaseNervous System DiseasesNeurologic ManifestationsPathologic ProcessesPsychomotor AgitationPsychomotor DisordersRestless Legs SyndromeSleep Wake DisordersSyndromeNeurobehavioral ManifestationsParasomniasDyskinesiasSleep Disorders, IntrinsicDyssomnias

Criteria

* INCLUSION CRITERIA: 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. EXCLUSION CRITERIA: 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).

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, United StatesSee the location
CompletedOne Study Center