Interoceptive network connectivity in restless legs syndrome
Functional Connectivity of the Interoceptive Network in Restless Legs Syndrome (RLS) : an Anatomical-clinical Prospective Study Based on Daily-life Assessment
This project will test whether insular brain connectivity and people's ability to sense their internal body signals differ across the day in adults with restless legs syndrome compared with healthy adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University Hospital, Bordeaux Academic / other |
| Locations | 1 site (Bordeaux) |
| Trial ID | NCT07001891 on ClinicalTrials.gov |
What this trial studies
This project compares adults with idiopathic RLS to matched healthy controls to examine how interoceptive awareness and insular cortex functional connectivity change across the day. Participants will complete two weeks of ambulatory monitoring using a study smartphone for ecological momentary assessment and a wearable actigraph to capture sleep/wake patterns and symptom timing. Clinical questionnaires and laboratory visits include interoception testing and resting-state functional MRI scans timed to morning and evening to measure diurnal fluctuations in insular connectivity. Investigators will correlate interoceptive measures, symptom diaries, and imaging connectivity to test whether altered interoception and insular network dynamics explain RLS symptoms.
Who should consider this trial
Good fit: Adults aged 18–70 with idiopathic RLS who meet the five diagnostic criteria, have a normal clinical exam, and can consent and participate in ambulatory monitoring and MRI are ideal candidates.
Not a fit: People with secondary RLS (for example renal failure or pregnancy), significant psychiatric illness, chronic non-RLS pain, peripheral neuropathy, uncontrolled sleep disorders, or other unstable medical conditions are unlikely to receive benefit from this protocol.
Why it matters
Potential benefit: If successful, this could clarify brain mechanisms behind RLS and suggest new targets or optimal timing for treatments to reduce symptoms.
How similar studies have performed: Related imaging and interoception studies have shown promising links in other disorders, but applying diurnal insular connectivity and ecological interoception measures specifically to RLS is relatively novel and not yet established.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Bordeaux
- CHU de Bordeaux - Neurophysiologie Clinique de l'Enfant et de l'Adulte — Bordeaux, France (Recruiting)
Study contacts
- Principal investigator: Imad Marc Antoine GHORAYEB, MD, PhD — University Hospital, Bordeaux
- Study coordinator: Imad Marc Antoine GHORAYEB, MD, PhD
- Email: marc-antoine.ghorayeb@chu-bordeaux.fr
- Phone: (0)5.56.79.55.13
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.