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Analysis of Sympathetic Activity in Willis-Ekbom Disease
Led by University Hospital, Montpellier · Updated on 2025-10-02
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Willis-Ekbom disease (WED), also called restless legs syndrome (RLS), is a common neurological disorder that affects sleep and quality of life. It is thought to involve central dopamine dysfunction linked to brain iron deficiency. Many people with WED have periodic limb movements during sleep, which cause sleep interruptions and repeated rises in blood pressure and heart rate. These changes may increase the risk of hypertension and cardiovascular diseases. This study aims to compare autonomic nervous system activity in patients with WED to healthy volunteers to better understand these risks. Participants will undergo measurements of cardiac sympathetic activity using a special imaging test called 123I-metaiodobenzylguanidine (123I-MIBG) scintigraphy. Additional tests include blood and urine samples to measure inflammatory markers and catecholamine levels, as well as 24-hour ambulatory blood pressure and heart rate monitoring. The study groups include patients diagnosed with WED and healthy control volunteers. These assessments will help analyze differences in sympathetic nerve activity and cardiovascular function between the groups. During the study, participants will have imaging scans, blood pressure monitoring over 24 hours, and laboratory tests on blood and urine samples. Researchers will measure heart and blood pressure changes related to sleep stages, limb movements, and arousals. The main outcome is the heart-to-mediastinum ratio from the 123I-MIBG scan, indicating cardiac sympathetic activity. Secondary outcomes include the washout rate of the tracer, circadian blood pressure patterns, and biomarker levels. The study began in 2017 and is ongoing until 2027, involving adults aged 18 to 74 years.
CONDITIONS
Brief Title
Analysis of Sympathetic Activity in Willis-Ekbom Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older and less than 75 years
- French-speaking and able to understand the study
- Signed written informed consent
- Affiliated to social security
- For patients: meet 5 International RLS Study Group positive criteria
- For patients: Restless Legs Syndrome severity score of 15 or higher
- For patients: Ferritin level greater than 50 ng/ml
- For patients: Periodic limb movements index greater than 10 per hour
- For patients: Idiopathic Willis-Ekbom disease with at least 3 years duration and symptoms at least 3 times per week
- For patients: No use of dopaminergic agonists, pregabalin, or gabapentin in the last 8 days
You will not qualify if you...
- Vulnerable subjects including those deprived of liberty or protected by law, pregnant or breastfeeding women
- Participation in another research study within exclusion period
- Malignant neoplastic disease treated in the last 12 months
- History of cardiovascular disease including ischemic heart disease, heart failure, stroke, hypertension, or sleep apnea syndrome
- Use of antidepressants, neuroleptics, sympathomimetics, sympatholytics, vasculotropic drugs, dopamine agonists, or opiates
- For patients: Secondary restless legs syndrome due to renal failure, hemochromatosis, neurological disorders, or iatrogenesis
- For healthy volunteers: Diagnosis of Willis-Ekbom Disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo polysomnography, MIBG myocardic scintigraphy, and 24-hour blood pressure monitoring to assess cardiac sympathetic activity and related biomarkers.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
University Hospital of Montpellier
Montpellier, France, 34295
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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