Measuring nerve system activity in people with Willis-Ekbom disease (restless legs syndrome)
Compares sympathetic nerve activity in people with Willis-Ekbom disease and healthy volunteers.
Key facts
- Who runs it
- University Hospital, Montpellier
- Where
- France1 site in 1 countryChoose a country to see its sites
- Trial code
- Registry title
- Analysis of Sympathetic Activity in Willis-Ekbom Disease
- Status
- Recruiting
- People taking part
- 40 people, planned
- Started
- 21 Mar 2017
- Expected to end
- 5 Oct 2027
- Type of study
- Interventional, 2 groups
- Treatments tested
- Sympathetic nervous activity measurement
- Record updated
- 2 October 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with restless legs syndrome (Willis-Ekbom disease), and healthy volunteers without it for comparison. It measures nerve activity that controls the heart and blood pressure.
- Age
- 18 to 74 years (18 or more and less than 75).
- Sex
- All sexes can join.
- Disease stage
- Patients: idiopathic (primary) restless legs syndrome for at least 3 years, symptoms at least 3 times a week, all 5 IRLSSG 2012 criteria, IRLS severity score ≥ 15, and periodic limb movements index > 10/hour.
- Earlier treatment
- Patients must not have taken dopaminergic agonists, pregabalin or gabapentin in the last 8 days. No one may take antidepressant, neuroleptic, sympathomimetic, sympatholytic, vasculotropic, dopamine agonist or opiate treatments.
- Biomarker or test result
- Patients: ferritin > 50 ng/ml.
Main reasons for not taking part
- Pregnant or breastfeeding women, or people under legal protection or deprived of liberty.
- Cancer treated in the last 12 months.
- History of heart or blood vessel disease, high blood pressure, stroke or sleep apnea.
- Restless legs caused by kidney failure, hemochromatosis, nerve disorders or medicines.
- Healthy volunteers cannot join if they have Willis-Ekbom disease.
The registry criteria, word for word
Show all 5 criteriaShow less
Who can take part
- 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 dopaminergic agonists or pregabalin or gabapentin in the last 8 days, at least 3 years of disease duration with symptoms recurring at least 3 times a week
Who cannot take part
- 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, neurologic disorders, iatrogenesis
- CONTROL-specific exclusion criteria - Willis-Ekbom Disease
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 74 years old?
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
Willis-Ekbom disease (WED), also known as restless legs syndrome (RLS) is a common neurological sensorimotor disorder that typically impairs sleep and quality of life, likely consequent to a central dopaminergic dysfunction associated to brain iron deficiency. Periodic limb movements (PLMS) in sleep are present in 80% of patients with WED. PLMS are often associated with micro-arousals that contribute to sleep fragmentation and repeated increases of blood pressure and heart rate throughout the night, thus representing an increased risk for hypertension and cardiovascular diseases (CVD).
Read full original descriptionShow less
Willis-Ekbom disease affects people with higher cardiovascular risk factors, such as advanced age, obesity, diabetes mellitus and hypercholesterolemia. However, previous observational, cross-sectional or longitudinal population-based studies on the association between RLS and CVD and hypertension showed controversial results.
While the pathophysiology of RLS is yet to be elucidated and is likely multifactorial, one theory involves a reduction in dopaminergic outflow to the preganglionic sympathetic neurons in the dorsal horn of the spinal cord. Dopamine inhibits preganglionic sympathetic neurons, therefore a reduction in dopamine may in turn increase sympathetic outflow.
Based on this notion, the investigators hypothesize an increase of sympathetic autonomic activity in Willis-Ekbom disease responsible for the recurrent increase in blood pressure and heart rate during sleep, which may play a role in increasing the risk of cardiovascular diseases.
The aim of this study is to analyze the autonomic nervous activity in patients with WED compared to healthy volunteers controls. The investigators will measure primarily the cardiac sympathetic activity by the 123I-metaiodobenzylguanidine (123I-MIBG) scintigraphy and secondarily the sympathetic nerve activity by the plasmatic pro inflammatory biomarkers and urinary catecholamine levels and the circadian variation of blood pressure and heart rate as assessed by the 24-hour ambulatory blood pressure monitoring.
The 2 groups in the trial
- Willis-Ekbom disease patients (CASE)Treatment being tested
Treatment: Sympathetic nervous activity measurement
- Healthy volunteers (CONTROL)Treatment being tested
Treatment: Sympathetic nervous activity measurement
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Analysis of Sympathetic Activity in Willis-Ekbom Disease
- Plain-language title
- Measuring nerve system activity in people with Willis-Ekbom disease (restless legs syndrome)Generated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Fit questions
- Built from NCT02929732, who can take part
- Record updated
- 2 October 2025