Funksjonell tilkobling av det interoceptive nettverket i RLS (IntoRLS)
Funksjonell tilkobling av det interoceptive nettverket i Restless Legs Syndrome (RLS): En anatomisk-klinisk prospektiv studie basert på vurdering av daglig liv
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.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
Despite extensive research into the pathophysiology of RLS, no unified mechanism has been identified to explain the prominent clinical features of the disorder, including both sensorimotor and non-motor symptoms. One plausible hypothesis is that RLS symptoms are related to abnormal brain function in processing internally generated stimuli, particularly interoception. Distorted perceptions of the internal bodily state can lead to maladaptive behaviors, which may manifest in a wide range of medical disorders, including RLS, attention-deficit/hyperactivity disorder (ADHD), insomnia, eating disorders/obesity, fibromyalgia, and psychiatric conditions. The interoceptive abilities of RLS patients, specifically their capacity to perceive and assess their internal bodily state, have not been extensively studied, despite their potential to deepen our understanding of the sensorimotor discomfort in the legs and associated non-motor symptoms. The IntoRLS project will therefore precisely characterize the temporal variation in symptom severity and interoceptive awareness in RLS patients, alongside their sleep/wake cycle disturbances, using ambulatory assessments. This ecological assessment will be linked to time-of-day variations in intrinsic insular connectivity, assessed via functional brain imaging. At the inclusion visit, eligible participants (both patients and matched controls) will be provided with a study-dedicated smartphone for a two-week period, as well as a wearable actigraph to monitor their activity/rest cycles. Participants will complete self-reported questionnaires assessing the severity of RLS symptoms, ADHD symptoms, anxiety and depression, daytime sleepiness, and arousal predisposition. At the end of the participation period (J+14), participants will undergo functional brain imaging sessions in the morning and evening. Between the two sessions, each participant will complete the Multidimensional Assessment of Interoceptive Awareness (MAIA-2) questionnaire and perform the Heartbeat Detection Task to evaluate interoceptive accuracy.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Imad Marc Antoine GHORAYEB, MD, PhD
- Telefonnummer: +33 (0)5.56.79.55.13
- E-post: marc-antoine.ghorayeb@chu-bordeaux.fr
Studer Kontakt Backup
- Navn: Fatima-Zahra MAKHOUKHI
- E-post: fatima-zahra-makhoukhi@chu-bordeaux.fr
Studiesteder
-
-
-
Bordeaux, Frankrike
- Rekruttering
- CHU de Bordeaux - Neurophysiologie Clinique de l'Enfant et de l'Adulte
-
Ta kontakt med:
- Imad Marc-Antoine GHORAYEB, MD, PhD
- Telefonnummer: +33 (0)5.56.79.55.13
- E-post: marc-antoine.ghorayeb@chu-bordeaux.fr
-
Hovedetterforsker:
- Imad Marc-Antoine GHORAYEB, MD, PhD
-
Ta kontakt med:
- Fatima-Zahra MAKHOUKHI
- E-post: fatima-zahra-makhoukhi@chu-bordeaux.fr
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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).
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: sunne kontroller
|
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)). 4 electronic interviews administered per day during 14 days by a study-dedicated Android OS smartphone 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. 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) Morning and evening functional brain imaging |
|
Eksperimentell: Restless Legs Syndrome
|
RLS history, RLS treatments, and International Restless Legs Syndrome Rating Scale (IRLSRS) will be recorded 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)). 4 electronic interviews administered per day during 14 days by a study-dedicated Android OS smartphone 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. 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) Morning and evening functional brain imaging |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Functional Connectivity (FC) of the anterior and posterior insular cortex (IC) measured at rest.
Tidsramme: 14 days after baseline (Day 0)
|
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)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Correlations will be explored between the scores obtained by patients and those of the healthy volunteer group on the various self-assessment scales.
Tidsramme: 14 days after baseline (Day 0)
|
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:
|
14 days after baseline (Day 0)
|
|
Correlations will be explored between the severity score of the RLS and sleep parameters
Tidsramme: 14 days after baseline (Day 0)
|
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. |
14 days after baseline (Day 0)
|
|
Correlations will be explored between altered functional connectivity of the patients' insular cortex
Tidsramme: 14 days after baseline (Day 0)
|
(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. |
14 days after baseline (Day 0)
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Studiestol: Gwénaëlle CATHELINE, PhD, Université de Bordeaux - INCIA
- Hovedetterforsker: Imad Marc Antoine GHORAYEB, MD, PhD, University Hospital, Bordeaux
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CHUBX 2024/68
- 2024-A02497-40 (Annen identifikator: ANSM)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .