Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
Healthy Volunteers
NCT07001891

Functional Connectivity of the Interoceptive Network in RLS

Led by University Hospital, Bordeaux · Updated on 2025-09-17

30

Participants Needed

1

Research Sites

54 weeks

Total Duration

On this page

Sponsors

U

University Hospital, Bordeaux

Lead Sponsor

R

Restless Legs Syndrome Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Functional Connectivity of the Interoceptive Network in RLS

Who Can Participate

Age: 18Years - 70Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 70 years
  • For patients: diagnosis of idiopathic RLS based on medical history and presence of 5 RLS diagnostic criteria
  • Normal clinical examination
  • Affiliated to or benefiting from a social security scheme
  • Provided free, informed, written consent prior to participation
Not Eligible

You will not qualify if you...

  • Significant psychiatric illness or mood disorder
  • History or presence of chronic pain unrelated to RLS, epilepsy, serious head injury, peripheral neuropathy, or diabetes
  • Clinically significant sleep apnea, narcolepsy, or secondary causes of RLS (e.g., chronic renal failure, pregnancy)
  • Other active significant illnesses such as unstable cardiovascular or neoplastic diseases
  • Contraindications to MRI (e.g., pacemakers, aneurysm clips, metal implants, claustrophobia)
  • Pregnant or breastfeeding women
  • Persons deprived of liberty, minors, adults under legal protection, or unable to consent

AI-Screening

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Trial Site Locations

Total: 1 location

1

CHU de Bordeaux - Neurophysiologie Clinique de l'Enfant et de l'Adulte

Bordeaux, France

Actively Recruiting

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Research Team

I

Imad Marc Antoine GHORAYEB, MD, PhD

CONTACT

F

Fatima-Zahra MAKHOUKHI

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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