Functional Connectivity of the Interoceptive Network in Restless Legs Syndrome (RLS) : an Anatomical-clinical Prospective Study Based on Daily-life Assessment

Status: Recruiting
Location: See location...
Intervention Type: Device, Behavioral, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Restless Legs Syndrome (RLS) is a sensorimotor disorder primarily characterized by an irresistible urge to move the legs while at rest. A key hypothesis suggests that RLS symptoms are linked to abnormal brain function in processing internally generated stimuli, particularly interoception. This distorted perception of the internal bodily state leads to maladaptive behaviors, which may manifest across a wide range of medical and psychiatric disorders. Here, the investigators hypothesize that dysfunction in the insular cortex (IC) may result in a failure of behavioral adaptation, primarily expressed as an urge to move the legs and hyperarousal, even when the body and mind need rest. This project aims to assess the relationship between interoceptive abilities and diurnal fluctuations in IC functional connectivity (FC) in patients with RLS compared to healthy controls. The investigators will also examine correlations between the FC of the interoceptive network, measured in the morning and evening on the same day, using multilayer network analysis, daily fluctuations in RLS symptom severity, and objective measurements of the sleep/wake cycle, gathered through a two-week ambulatory assessment using mobile technologies such as Ecological Momentary Assessment (EMA) and actigraphy, along with scores from self-reported questionnaires. The findings may provide strong evidence to support or refute the hypothesis of interoceptive dysfunction in RLS patients.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: t
View:

• Person aged from 18 to 70 years

• Only for the patients : ny patient with a diagnosis of idiopathic RLS based on medical history and the presence of the 5 RLS diagnostic criteria

• Normal clinical examination

• Person affiliated or benefiting from a social security scheme

• Free, informed and written consent signed by the participant and the investigator (no later than the day of inclusion and prior to any review required by the research).

Locations
Other Locations
France
CHU de Bordeaux - Neurophysiologie Clinique de l'Enfant et de l'Adulte
RECRUITING
Bordeaux
Contact Information
Primary
Imad Marc Antoine GHORAYEB, MD, PhD
marc-antoine.ghorayeb@chu-bordeaux.fr
(0)5.56.79.55.13
Backup
Fatima-Zahra MAKHOUKHI
fatima-zahra-makhoukhi@chu-bordeaux.fr
Time Frame
Start Date: 2025-09-16
Estimated Completion Date: 2026-10
Participants
Target number of participants: 30
Treatments
Experimental: Restless Legs Syndrome
Active_comparator: healthy controls
Related Therapeutic Areas
Sponsors
Collaborators: Restless Legs Syndrome Foundation
Leads: University Hospital, Bordeaux

This content was sourced from clinicaltrials.gov