Analysis of Sympathetic Activity in Willis-Ekbom Disease

  • STATUS
    Recruiting
  • participants needed
    40
  • sponsor
    University Hospital, Montpellier
Updated on 7 September 2021
deficiency
iron
spinal cord
hypertension
ambulatory blood pressure monitoring
gabapentin
restless legs syndrome
polysomnography
catecholamine
scintigraphy
pregabalin
sleep fragmentation
nervous
cardiovascular diseases
restlessness
motor disorder
metaiodobenzylguanidine
Accepts healthy volunteers
dopamine
diabetes

Summary

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.

Details
Condition nervous system disorder, Neurologic Disorders, Restless Leg Syndrome, Restless Legs Syndrome
Age 18years - 74years
Treatment Sympathetic nervous activity measurement
Clinical Study IdentifierNCT02929732
SponsorUniversity Hospital, Montpellier
Last Modified on7 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Non-specific inclusion criteria (CASE + CONTROL)
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
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

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, neurologic disorders, iatrogenesis
CONTROL-specific exclusion criteria - Willis-Ekbom Disease
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