NCT02929732: MIBG-RLS

Analysis of Sympathetic Activity in Willis-Ekbom Disease

Recruiting now NA Last updated 2 October 2025

What this trial tests

NA trial testing Sympathetic nervous activity measurement in Willis-Ekbom Disease in 40 participants. Currently enrolling.

Timeline

21 March 2017

Primary endpoint
5 October 2027

5 October 2027

Quick facts

Lead sponsor	University Hospital, Montpellier
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	basic science
Enrollment	40
Start date	21 March 2017
Primary completion	5 October 2027
Estimated completion	5 October 2027
Sites	1 location across France

Drugs / interventions tested

• Sympathetic nervous activity measurement

Conditions studied

• Willis-Ekbom Disease — all drugs for Willis-Ekbom Disease →
• Restless Legs Syndrome — all drugs for Restless Legs Syndrome →

Sponsor

University Hospital, Montpellier

Who can join

Adults 18 to 74, any sex, with Willis-Ekbom Disease or Restless Legs Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.