Functional Connectivity of the Interoceptive Network in RLS

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity Hospital, Bordeaux

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

30 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University Hospital, Bordeaux

Lead sponsor

Restless Legs Syndrome Foundation

Collaborator