Restless Legs SyndromeNCT00074672
Relationship Between Sensory and Motor Systems in Restless Leg Syndrome
An observational study of Restless Legs Syndrome, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Restless Legs Syndrome
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2003to 14 Apr 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who meet all of the following inclusion criteria at screening will be eligible to participate in the study:
- 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.
Who cannot join
- Subjects meeting any of the following exclusion criteria will not be enrolled or will be immediately excluded from the study, as appropriate:
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Sensorimotor Gating Studies in Restless Legs Syndrome
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.
Read the 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.
- Conditions
- Restless Legs Syndrome
- Keywords
- Prepulse Inhibition, PPI, Dopamine, Sensorimotor Integration, Dopaminergic
- Medical subject headings
- Restless Legs Syndrome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2003 (estimated)
- Study start12 Dec 2003
- Study completion14 Apr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Restless Legs SyndromeStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 45 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00074672
- Sponsor's protocol ID
- 040059
- Other IDs
- 04-N-0059
- Status last verified
- 14 Apr 2009
- First submitted
- 17 Dec 2003
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
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.
PubMed 8552117Silber MH. Restless legs syndrome. Mayo Clin Proc. 1997 Mar;72(3):261-4. doi: 10.4065/72.3.261.
PubMed 9070203Ondo W, Jankovic J. Restless legs syndrome: clinicoetiologic correlates. Neurology. 1996 Dec;47(6):1435-41. doi: 10.1212/wnl.47.6.1435.
PubMed 8960723
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensorimotor Gating Studies in Restless Legs Syndrome
- ClinicalTrials.gov ID
- NCT00074672
- Acronym / sponsor ID
- 040059
- Conditions
- Restless Legs Syndrome
- Keywords
- Prepulse Inhibition, PPI, Dopamine, Sensorimotor Integration, Dopaminergic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 12 Dec 2003
- Study completion
- 14 Apr 2009
- First posted
- 18 Dec 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects who meet all of the following inclusion criteria at screening will be eligible to participate in the study:
- 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.
Key exclusion criteria (6 listed)
- Subjects meeting any of the following exclusion criteria will not be enrolled or will be immediately excluded from the study, as appropriate:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 8552117Walters 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.
- Background: PubMed 9070203Silber MH. Restless legs syndrome. Mayo Clin Proc. 1997 Mar;72(3):261-4. doi: 10.4065/72.3.261.
- Background: PubMed 8960723Ondo W, Jankovic J. Restless legs syndrome: clinicoetiologic correlates. Neurology. 1996 Dec;47(6):1435-41. doi: 10.1212/wnl.47.6.1435.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Restless Legs Syndrome, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00074672, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.