Functional Connectivity of the Interoceptive Network in RLS

NCT07001891 | Recruiting

• 1 other identifier: CHUBX 2024/68
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Restless Legs Syndrome

Keywords

Restless Legs Syndrome; Interoception; Insular Cortex; Functional Connectivity

Outcome Measures

Primary Outcomes (1)

• Functional Connectivity (FC) of the anterior and posterior insular cortex (IC) measured at rest.

  The investigators hypothesize that this connectivity will differ between patients and control subjects. This outcome will be assessed through the temporal fluctuation of the BOLD signal measured during the MRI examination conducted in the morning and again in the evening.

  14 days after baseline (Day 0)

Secondary Outcomes (3)

• Correlations will be explored between the scores obtained by patients and those of the healthy volunteer group on the various self-assessment scales.

  14 days after baseline (Day 0)

• Correlations will be explored between the severity score of the RLS and sleep parameters

  14 days after baseline (Day 0)

• Correlations will be explored between altered functional connectivity of the patients' insular cortex

  14 days after baseline (Day 0)

Study Arms (2)

Restless Legs Syndrome

EXPERIMENTAL

Other: Clinical assessment; Behavioral: auto-questionnaires (PSQI, ISI, ESS and HADS); Device: Ecological Momentary Assessment (EMA); Device: activity-rest cycle; Behavioral: auto-questionnaires (ASRS, PSAS, APS, MAIA-2); Device: MRI

healthy controls

ACTIVE COMPARATOR

Behavioral: auto-questionnaires (PSQI, ISI, ESS and HADS); Device: Ecological Momentary Assessment (EMA); Device: activity-rest cycle; Behavioral: auto-questionnaires (ASRS, PSAS, APS, MAIA-2); Device: MRI

Interventions

Clinical assessment OTHER

RLS history, RLS treatments, and International Restless Legs Syndrome Rating Scale (IRLSRS) will be recorded

Restless Legs Syndrome

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)).

Restless Legs Syndrome; healthy controls

Ecological Momentary Assessment (EMA) DEVICE

4 electronic interviews administered per day during 14 days by a study-dedicated Android OS smartphone

Restless Legs Syndrome; healthy controls

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.

Restless Legs Syndrome; healthy controls

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)

Restless Legs Syndrome; healthy controls

MRI DEVICE

Morning and evening functional brain imaging

Restless Legs Syndrome; healthy controls

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• Restless Legs Syndrome Foundation: collaborator

Study Sites (1)

CHU de Bordeaux - Neurophysiologie Clinique de l'Enfant et de l'Adulte

Bordeaux, France

RECRUITING

MeSH Terms

Conditions

Restless Legs Syndrome

Interventions

4-amino-4'-hydroxylaminodiphenylsulfone

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Study Officials

• Imad Marc Antoine GHORAYEB, MD, PhD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

• Gwénaëlle CATHELINE, PhD

  Université de Bordeaux - INCIA

  STUDY CHAIR

Central Study Contacts

Imad Marc Antoine GHORAYEB, MD, PhD

CONTACT

(0)5.56.79.55.13; marc-antoine.ghorayeb@chu-bordeaux.fr

Fatima-Zahra MAKHOUKHI

CONTACT

fatima-zahra-makhoukhi@chu-bordeaux.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: June 3, 2025
• Study Start: September 16, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)