Functional Connectivity of the Interoceptive Network in RLS
ConditionRestless Legs Syndrome
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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Clinical assessment
Other interventionRLS history, RLS treatments, and International Restless Legs Syndrome Rating Scale (IRLSRS) will be recorded
auto-questionnaires (PSQI, ISI, ESS and HADS)
BehavioralTo 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)
Device4 electronic interviews administered per day during 14 days by a study-dedicated Android OS smartphone
activity-rest cycle
DeviceTo 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)
BehavioralInteroceptive 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
DeviceMorning and evening functional brain imaging
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Restless Legs SyndromeExperimental treatment 6 interventions
Group B: healthy controlsActive comparator 5 interventions
Trial outcomes
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.
Time frame
14 days after baseline (Day 0)Secondary outcomes
1
Correlations will be explored between the scores obtained by patients and those of the healthy volunteer group on the various self-assessment scales.
Score comparisons on these same scales will also be conducted between the patient group and the healthy volunteer group. The scores analyzed will be those obtained on the following scales: * International Restless Legs Syndrome Rating Scale (IRLSRS) (to assess the severity of RLS), * Insomnia Severity Index (ISI), * Adult ADHD Self-Report Scale (ASRS) (to screen for symptoms of ADHD), * Hospital Anxiety and Depression Scale (HADS) (to assess levels of depression and anxiety), * Multidimensional Assessment of Interoceptive Awareness Version 2 (MAIA-2) (to evaluate interoceptive awareness), * Pre-Sleep Arousal Scale (PSAS) and Arousal Predisposition Scale (APS) (to measure levels of hypervigilance), * Epworth Sleepiness Scale (ESS) (to assess hypersomnolence).
Time frame
14 days after baseline (Day 0)2
Correlations will be explored between the severity score of the RLS and sleep parameters
assessed by actigraphy (specific measures including: Total Sleep Duration \[minutes\], Sleep Efficiency \[%\], Wake After Sleep Onset \[minutes\], and Sleep Onset Latency \[minutes\]) as well as scores from Ecological Momentary Assessment smartphone questionnaires.
Time frame
14 days after baseline (Day 0)3
Correlations will be explored between altered functional connectivity of the patients' insular cortex
(measured by statistical synchrony or temporal correlation of BOLD \[Blood Oxygen Level Dependent\] signals across different brain regions) and sleep parameters assessed by actigraphy (specific measures including Total Sleep Duration \[minutes\], Sleep Efficiency \[%\], Wake After Sleep Onset \[minutes\], and Sleep Onset Latency \[minutes\]) as well as scores from Ecological Momentary Assessment smartphone questionnaires. Comparisons will also be made with results obtained from the healthy volunteer group.
Time frame
14 days after baseline (Day 0)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Bordeaux
Lead sponsor
Restless Legs Syndrome Foundation
Collaborator
Source ClinicalTrials.gov