Functional Connectivity of the Interoceptive Network in RLS

Launched by UNIVERSITY HOSPITAL, BORDEAUX · May 23, 2025

Keywords

ClinConnect Summary

This clinical trial is studying Restless Legs Syndrome (RLS), a condition that causes an overwhelming urge to move the legs, especially when at rest. The researchers believe that RLS may be related to how the brain processes our internal feelings and sensations, particularly in a part of the brain called the insular cortex. By comparing patients with RLS to healthy individuals, the study aims to understand how different brain functions might affect RLS symptoms and daily behaviors. Participants will be monitored over two weeks using mobile technologies to track their symptoms and sleep patterns, providing valuable insights into the relationship between brain function and RLS.

To be eligible for this trial, participants need to be between 18 and 70 years old and have a confirmed diagnosis of idiopathic RLS. They should not have significant psychiatric conditions, chronic pain unrelated to RLS, or other serious health issues that could interfere with the study. Participants will be asked to provide informed consent before joining the study. Throughout the trial, those involved can expect a comprehensive evaluation of their symptoms, brain activity, and daily routines, contributing to a better understanding of RLS.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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).