Actively Recruiting
Functional Connectivity of the Interoceptive Network in Restless Legs Syndrome (RLS): an Anatomical-clinical Prospective Study Based on Daily-life Assessment
Led by University Hospital, Bordeaux · Updated on 2025-09-17
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University Hospital, Bordeaux
Lead Sponsor
R
Restless Legs Syndrome Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Restless Legs Syndrome (RLS) is a condition marked by an uncontrollable urge to move the legs when at rest, possibly linked to abnormal brain processing of internal body signals called interoception. Researchers believe that dysfunction in a brain area called the insular cortex may cause symptoms like leg discomfort and increased alertness, even when rest is needed. This study aims to explore how interoceptive abilities and brain connectivity change throughout the day in people with RLS compared to healthy individuals, using advanced brain imaging and daily symptom tracking. Participants will use a study smartphone and a wrist-worn actigraph for two weeks to monitor their activity and rest cycles while completing questionnaires about RLS symptoms, mood, sleepiness, and arousal. After this period, they will undergo brain scans twice in one day—once in the morning and once in the evening—to measure functional connections in the insular cortex. The study also includes assessments of interoceptive awareness and accuracy through specific questionnaires and tasks. Throughout the study, participants will provide detailed daily self-reports via electronic interviews and wear devices to track sleep and activity patterns. Researchers will analyze correlations between brain connectivity, symptom fluctuations, and sleep cycles. The main outcome measure is the functional connectivity of the insular cortex assessed 14 days after the start. This comprehensive approach includes both behavioral and brain imaging assessments to understand how internal body awareness relates to RLS symptoms over time.
CONDITIONS
Brief Title
Functional Connectivity of the Interoceptive Network in RLS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Person aged from 18 to 70 years
- Diagnosis of idiopathic Restless Legs Syndrome based on medical history and presence of 5 RLS diagnostic criteria (patients only)
- Normal clinical examination
- Affiliated or benefiting from a social security scheme
- Free, informed, and written consent signed by participant and investigator prior to any study procedures
You will not qualify if you...
- Significant psychiatric illness or mood disorder
- History or presence of chronic pain unrelated to RLS, epilepsy, serious head injury, peripheral neuropathy, or diabetes
- Clinically significant sleep apnea, narcolepsy, or secondary causes of RLS such as chronic renal failure, hemodialysis, or pregnancy
- Other active clinically significant illnesses including unstable cardiovascular or neoplastic conditions that may interfere with study
- Contraindications to MRI such as pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments, claustrophobia, or refusal of MRI
- Pregnant or breastfeeding women
- Persons deprived of liberty, minors, adults under legal protection, or unable to give consent
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 day
Participants complete self-reported questionnaires assessing RLS symptom severity, ADHD symptoms, anxiety and depression, daytime sleepiness, and arousal predisposition. They receive a study-dedicated smartphone and wearable actigraph to monitor their activity/rest cycles during daily life.
1 visit (in-person)
Duration - 14 days
Participants complete 4 electronic interviews per day using the study smartphone and wear the actigraph on their non-dominant wrist to monitor activity/rest cycles over 14 days.
Daily electronic interviews 4 times per day and continuous actigraphy for 14 days
Duration - 2 sessions on the same day after 14-day monitoring period
Participants undergo morning and evening functional brain imaging sessions. They complete the Multidimensional Assessment of Interoceptive Awareness (MAIA-2) questionnaire and perform the Heartbeat Detection Task to evaluate interoceptive accuracy.
2 visits (morning and evening, in-person)
Trial Site Locations
Total: 1 location
1
CHU de Bordeaux - Neurophysiologie Clinique de l'Enfant et de l'Adulte
Bordeaux, France
Actively Recruiting
Research Team
I
Imad Marc Antoine GHORAYEB, MD, PhD
F
Fatima-Zahra MAKHOUKHI
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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