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Exploration of the Reward System by Functional MRI in Narco-cataplexy Patients With and Without REM Sleep Behavior Disorder

Exploration of the Reward System by Functional MRI in Narco-cataplexy Patients With and Without REM Sleep Behavior Disorder

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03425214
Acronym
NC-TCSP-IRMf
Enrollment
66
Registered
2018-02-07
Start date
2018-01-19
Completion date
2019-06-30
Last updated
2018-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataplexy, Narcolepsy

Keywords

functional MRI, Reward system, REM sleep behaviour disorder, Narco-cataplexy

Brief summary

Up to 50% of Narcolepsy-cataplexy (NC) patients suffer from REM sleep behavior disorder (RBD), a parasomnia. A strong link was found between RBD and impulse control disorders (ICD) in Parkinson disease (PD) patients. ICD are thought to be related to a dysfunction of meso-cortico-limbic pathways which belong to the so called ''reward system''. A recent study in IRMf shows that RBD is associated with impaired reward system. A strong link was found between these two disorders and therefore we believe that RBD is associated with impaired reward system in NC The main objective of this study is to evaluate differences in brain activation between NC patients with and without RBD. The investigators hypothesize that NC patients with RBD have a more severe dysfunction of the reward system (hypoactivation of the meso-cortico-limbic pathway) than patients without RBD.

Detailed description

Type of study: Prospective, case control study. Number of centers: 3 (Clermont-Ferrand, Vichy and Montlucon) Patients : The study will be performed in 66 subjects (22 PD patients with RBD, 22 PD patients without RBD and 22 healthy volunteers, age-and sex-matched without any contraindications to perform an MRI) Study Performance : During the first visit (Baseline, inclusion visit, 2 hours), each subject will perform a clinical and neurological examination and neuropsychological assessment (depression by the Beck Depression Inventory (BDI); apathy by the Lille Apathy Rating Scale (LARS), impulsivity by the Urgency, lack of Premeditation, lack of Perseverance, Sensation Seeking scale (UPPS)) Eligible patients will be welcomed for a video Polysomnography in the sleep center, for one night (Month 1, 1 night) and in a subsequent visit at the MRI department for the functional MRI (Month 1, 1 hour). This session will be of about 45 minutes. The reward system will be explore using an experimental task during functional Magnetic Resonance Imaging (fMRI). The name of this task is themonetary incentive delay task.

Interventions

OTHERfMRI

Session will be of about 45 minutes. The reward system will be explore using an experimental task during functional Magnetic Resonance Imaging (fMRI). The name of this task is themonetary incentive delay task.

OTHERVideopolysomnography

Video polysomnography will be perform in the sleep center during one night if patient did not have vPSG for 1 year.

OTHERNC (narcolepsy-cataplexy)

The investigators hypothesize that NC patients with RBD have a more severe dysfunction of the reward system (hypoactivation of the meso-cortico-limbic pathway) than patients without RBD.

Sponsors

CH MONTLUCON
CollaboratorUNKNOWN
Jacques Lacarin Hospital Center
CollaboratorOTHER
University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* \- Men or women, right handed, 18 to 80 years * Patients with type 1 Narcolepsy according to the criteria of the International Classification of Sleep, 3rd version, 2014 * Acceptance of the protocol and signature of a written consent * Social security affiliation

Exclusion criteria

* Previous history of psychosis or psychiatric disease * History of stroke or vascular lesion on MRI. * Perceptual disorder (vision, hearing) may hinder the realization of the protocols, * Dementia defined by a score across Montreal Cognitive Assessment (MoCA) \<26/30. * Major depressive state defined by a score scale Beck Depression Inventory (BDI)\> 14 * Apathy defined by a score ≥ 14 on the Apathy Scale of Starkstein. Patients with a score ≥ this one will be excluded. * Usual contraindications to MRI, knowing that no contrast agent injection is performed. * Pregnant woman.

Design outcomes

Primary

MeasureTime frameDescription
Measure of BOLD signal variation in each region of interestat Month 1BOLD signal variation in each region of interest (ventral tegmental area, accumbens nucleus, limbic cortex, prefrontal cortex) measured during fMRI

Secondary

MeasureTime frame
reaction time to the taskat Month 1
performance score to the taskat Month 1
Beck Depression Inventory score measured during fMRIat baseline
Lille Apathy Rating Scale score measured during fMRIat baseline
impulsivity score by the Urgency measured during fMRIat baseline

Countries

France

Contacts

Primary ContactPatrick LACARIN
placarin@chu-clermontferrand.fr04 73 75 11 95

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026