Clinical trial NCT03425214: Exploration of the Reward System by Functional MRI in Narco-cataplexy Patients With and Without REM Sleep Behavior Disorder
Official title: Exploration of the Reward System by Functional MRI in Narco-cataplexy Patients With and Without REM Sleep Behavior Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Narcolepsy
Cataplexy
Keywords: functional MRI
Reward system
REM sleep behaviour disorder
Narco-cataplexy
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: CH MONTLUCON
name: Jacques Lacarin Hospital Center
First posted: 2018-02-07
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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 the"monetary incentive delay task".

Eligibility criteria: 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.

Primary outcomes:
measure: Measure of BOLD signal variation in each region of interest
timeFrame: at Month 1
Secondary outcomes:
measure: reaction time to the task
timeFrame: at Month 1
measure: performance score to the task
timeFrame: at Month 1
measure: Beck Depression Inventory score measured during fMRI
timeFrame: at baseline
measure: Lille Apathy Rating Scale score measured during fMRI
timeFrame: at baseline
measure: impulsivity score by the Urgency measured during fMRI
timeFrame: at baseline
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Maria-Livia FANTINI
role: PRINCIPAL_INVESTIGATOR
References: