Status:

RECRUITING

Functional Connectivity of the Interoceptive Network in RLS

Lead Sponsor:

University Hospital, Bordeaux

Collaborating Sponsors:

Restless Legs Syndrome Foundation

Conditions:

Restless Legs Syndrome

Eligibility:

All Genders

18-70 years

Phase:

NA

Brief 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 abnorm...

Detailed Description

Despite extensive research into the pathophysiology of RLS, no unified mechanism has been identified to explain the prominent clinical features of the disorder, including both sensorimotor and non-mot...

Eligibility Criteria

Inclusion

  • 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).

Exclusion

  • Any significant psychiatric illness or mood disorder
  • History or presence of chronic pain other than that associated with RLS, history of epilepsy or serious head injury, history of peripheral neuropathy, diabetes
  • Clinically significant sleep apnea, narcolepsy, or any secondary causes of RLS (e.g. chronic renal failure/hemodialysis, pregnancy)
  • Other active clinically significant illness, including unstable cardiovascular, or neoplasic pathology which could interfere with the study conduct or interfere with study assessments or compromise the study participation
  • Contra-indication to MRI (pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body, claustrophobia or refusing MRI)
  • Pregnant or breastfeeding woman
  • Persons referred to in articles L.1121-5 to L.1121-8 (persons deprived of liberty by judicial or administrative decision, minors, adults subject to a legal protection measure or unable to express their consent).

Key Trial Info

Start Date :

September 16 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

October 1 2026

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT07001891

Start Date

September 16 2025

End Date

October 1 2026

Last Update

September 17 2025

Active Locations (1)

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1

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

Bordeaux, France