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Functional Connectivity of the Interoceptive Network in RLS

Sponsor: University Hospital, Bordeaux • ClinicalTrials.gov ID: NCT07001891

Registry updated: 2026-09-25

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Description

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.

Interventions

Clinical assessment (Other)
RLS history, RLS treatments, and International Restless Legs Syndrome Rating Scale (IRLSRS) will be recorded
auto-questionnaires (PSQI, ISI, ESS and HADS) (Behavioral)
To evaluate sleep quality, daytime somnolence and mood disorders (Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), Epworth Sleepiness Scale (ESS) and Hospital Anxiety and Depression Scale (HADS)).
Ecological Momentary Assessment (EMA) (Device)
4 electronic interviews administered per day during 14 days by a study-dedicated Android OS smartphone
activity-rest cycle (Device)
To further investigate the mutual influence of sleep quality on RLS symptoms and mood, the activity-rest cycle will be monitored by wearable actigraph to be placed on the non-dominant wrist during a period of 13 days and 14 nights.
auto-questionnaires (ASRS, PSAS, APS, MAIA-2) (Behavioral)
Interoceptive awareness and accuracy estimation : Adult ADHD Self-Report Scale (ASRS), Pre-Sleep Arousal Scale (PSAS), Arousal Predisposition Scale (APS) et Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2)
MRI (Device)
Morning and evening functional brain imaging

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).

Conditions

Restless Legs Syndrome

Locations

CHU de Bordeaux - Neurophysiologie Clinique de l'Enfant et de l'Adulte — Bordeaux, France

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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