Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00074672
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2003-12-17
Brief Title:
Relationship Between Sensory and Motor Systems in Restless Leg Syndrome
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Sensorimotor Gating Studies in Restless Legs Syndrome
Status:
COMPLETED
Status Verified Date:
2009-04-14
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 04-N-0059 | None | None | None |