Interoceptive network connectivity in restless legs syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.