NCT07001891 Functional Connectivity of the Interoceptive Network in RLS
| NCT ID | NCT07001891 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Bordeaux |
| Condition | Restless Legs Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-09-16 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2025-09-16 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
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).
Contact & Investigator
Imad Marc Antoine GHORAYEB, MD, PhD
PRINCIPAL INVESTIGATOR
University Hospital, Bordeaux
Frequently Asked Questions
Who can join the NCT07001891 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Restless Legs Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07001891 currently recruiting?
Yes, NCT07001891 is actively recruiting participants. Contact the research team at marc-antoine.ghorayeb@chu-bordeaux.fr for enrollment information.
Where is the NCT07001891 trial being conducted?
This trial is being conducted at Bordeaux, France.
Who is sponsoring the NCT07001891 clinical trial?
NCT07001891 is sponsored by University Hospital, Bordeaux. The principal investigator is Imad Marc Antoine GHORAYEB, MD, PhD at University Hospital, Bordeaux. The trial plans to enroll 30 participants.