Last updated: May 2, 2024
Sponsor: University Hospital, Montpellier
Overall Status: Active - Recruiting
Phase
N/A
Condition
Restless Leg Syndrome
Dyskinesias
Treatment
Sympathetic nervous activity measurement
Clinical Study ID
NCT02929732
9689
Ages 18-74 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Non-specific inclusion criteria (CASE + CONTROL)
- 18 years-old or more, and less than 75 years-old
- French-speaking
- able to understand the study
- signed written informed consent
- affiliated to social security
- CASE-specific inclusion criteria
- 5 " International RLS Study Group (IRLSSG) 2012 " positive criteria
- RLS severity scale (IRLS) score ≥ 15
- ferritin > 50 ng/ml
- periodic limb movements index > 10/hour
- idiopathic (or primary) Willis-Ekbom disease not treated with dopaminergicagonists or pregabalin or gabapentin in the last 8 days, at least 3 years ofdisease duration with symptoms recurring at least 3 times a week
Exclusion
Exclusion Criteria:
- Non-specific exclusion criteria (CASE + CONTROL)
- vulnerable subject : subject deprived of liberty or protected by law (trusteeship, legal guardianship), pregnant or breastfeeding woman
- exclusion period after other research protocol
- malignant neoplastic disease treated in the last 12 months
- medical history of cardiovascular disease (ischemic heart disease, heart failure,stroke, hypertension, sleep apnea syndrome)
- antidepressant, neuroleptic, sympathomimetic, sympatholytic, vasculotropic,dopamine agonists, opiate treatments
- CASE-specific exclusion criteria
- restless legs syndrome secondary to renal failure, hemochromatosis, neurologicdisorders, iatrogenesis
- CONTROL-specific exclusion criteria - Willis-Ekbom Disease
Study Design
Total Participants: 40
Treatment Group(s): 1
Primary Treatment: Sympathetic nervous activity measurement
Phase:
Study Start date:
March 21, 2017
Estimated Completion Date:
October 05, 2025
Connect with a study center
University Hospital of Montpellier
Montpellier, 34295
FranceActive - Recruiting
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