What is this Willis-Ekbom disease study trying to find out about restless legs syndrome?

This study is evaluating how the autonomic nervous system, especially cardiac sympathetic activity, differs in people with Willis-Ekbom disease compared to healthy volunteers. Researchers want to understand how this condition may increase the risk of cardiovascular problems. The study is sponsored by University Hospital, Montpellier and uses imaging and monitoring techniques to explore these effects.

Who may be eligible for this Willis-Ekbom disease clinical trial?

Adults aged 18 to 74 years who speak French and can understand the study are eligible. Participants with a diagnosis of Willis-Ekbom disease meeting specific severity and duration criteria may join. People with certain medical histories or recent treatments may be excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this Willis-Ekbom disease clinical trial?

Study-related care, including tests and all trial visits, is provided at no cost. However, personal travel or other expenses may vary and are not guaranteed to be covered. Participants should plan for any additional costs they may incur.

Actively Recruiting

Phase Not Applicable

Age: 18Years - 74Years

All Genders

Healthy Volunteers

ID02929732

Study of Sympathetic Nervous Activity in Adults with Willis-Ekbom Disease Compared to Healthy Volunteers

Led by University Hospital, Montpellier · Updated on 2025-10-02

Participants Needed

Research Sites

N/A

Total Duration

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

Age: 18Years - 74Years

All Genders

Healthy Volunteers

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

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