- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00074672
Relationship Between Sensory and Motor Systems in Restless Leg Syndrome
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.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
Studietype
Registrering
Kontakter og plasseringer
Studiesteder
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Maryland
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Bethesda, Maryland, Forente stater, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
- INCLUSION CRITERIA:
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.
EXCLUSION CRITERIA:
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).
Studieplan
Hvordan er studiet utformet?
Samarbeidspartnere og etterforskere
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
- Silber MH. Restless legs syndrome. Mayo Clin Proc. 1997 Mar;72(3):261-4. doi: 10.4065/72.3.261.
- Ondo W, Jankovic J. Restless legs syndrome: clinicoetiologic correlates. Neurology. 1996 Dec;47(6):1435-41. doi: 10.1212/wnl.47.6.1435.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Studiet fullført
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 040059
- 04-N-0059
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Makassed General HospitalFullført
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Yale UniversityMerz North America, Inc.FullførtRestless Leg SyndromeForente stater
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Chinese University of Hong KongFullførtObstruktivt søvnapnésyndrom | Restless Leg SyndromeHong Kong
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TC Erciyes UniversityRekrutteringSvangerskap | Sykepleie | Restless Leg SyndromeTyrkia
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Saint Thomas Hospital, PanamaFullførtAlvorlig preeklampsi | Restless Leg SyndromePanama
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Children's Hospitals and Clinics of MinnesotaFullførtJernmangel | Restless Leg SyndromeForente stater
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Roxane LaboratoriesFullførtParkinsons sykdom | Restless Leg Syndrome