Actively Recruiting

Phase Not Applicable
Age: 18Years - 74Years
All Genders
Healthy Volunteers
NCT02929732

Analysis of Sympathetic Activity in Willis-Ekbom Disease

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

40

Participants Needed

1

Research Sites

550 weeks

Total Duration

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AI-Summary

What this Trial Is About

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). 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.

CONDITIONS

Official Title

Analysis of Sympathetic Activity in Willis-Ekbom Disease

Who Can Participate

Age: 18Years - 74Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years-old or more, and less than 75 years-old
  • French-speaking and able to understand the study
  • Signed written informed consent
  • Affiliated to social security
  • For patients with Willis-Ekbom disease: meet at least 5 positive International RLS Study Group criteria from 2012
  • RLS severity score of 15 or higher
  • Ferritin level above 50 ng/ml
  • Periodic limb movements index greater than 10 per hour
  • Idiopathic Willis-Ekbom disease lasting at least 3 years with symptoms occurring at least 3 times a week
  • No treatment with dopaminergic agonists, pregabalin, or gabapentin in the last 8 days
Not Eligible

You will not qualify if you...

  • Vulnerable subjects including those deprived of liberty or under legal guardianship, pregnant or breastfeeding women
  • Participation in another research protocol during exclusion period
  • Malignant cancer treated within last 12 months
  • Medical history of cardiovascular disease such as ischemic heart disease, heart failure, stroke, hypertension, or sleep apnea syndrome
  • Current treatment with antidepressants, neuroleptics, sympathomimetics, sympatholytics, vasculotropic drugs, dopamine agonists, or opiates
  • Restless legs syndrome secondary to renal failure, hemochromatosis, neurological disorders, or caused by medication
  • Healthy controls with Willis-Ekbom disease

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Trial Site Locations

Total: 1 location

1

University Hospital of Montpellier

Montpellier, France, 34295

Actively Recruiting

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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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