Sensorimotor Gating Studies in Restless Legs Syndrome
Data Collection
Aberrant Motor Behavior in Dementia+14
+ Mental Disorders
+ Behavioral Symptoms
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.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.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
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
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, United StatesSee the location