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

Sponsor

University Hospital, Clermont-Ferrand (Other)

Overall Status

Unknown status

CT.gov ID

NCT03425214

Collaborator

CH MONTLUCON (Other), Jacques Lacarin Hospital Center (Other)

Enrollment

Location

Arms

17.3

Anticipated Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Narcolepsy Cataplexy	Other: fMRI Other: Videopolysomnography Other: NC (narcolepsy-cataplexy)	N/A

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".

Study Design

Study Type:

Interventional

Anticipated Enrollment :

66 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Jan 19, 2018

Anticipated Primary Completion Date :

Jun 30, 2019

Anticipated Study Completion Date :

Jun 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NC with RBD fMRI and video polysmnography	Other: fMRI 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". Other: Videopolysomnography Video polysomnography will be perform in the sleep center during one night if patient did not have vPSG for 1 year.
Experimental: NC without RBD fMRI and video polysomnography	Other: NC (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.
Experimental: control group (healthy subjects) fMRI	Other: fMRI 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".

Arm

Intervention/Treatment

Experimental: NC with RBD

fMRI and video polysmnography

Other: fMRI

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".

Other: Videopolysomnography

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

Experimental: NC without RBD

fMRI and video polysomnography

Other: NC (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.

Experimental: control group (healthy subjects)

fMRI

Other: fMRI

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

reaction time to the task [at Month 1]
performance score to the task [at Month 1]
Beck Depression Inventory score measured during fMRI [at baseline]
Lille Apathy Rating Scale score measured during fMRI [at baseline]
impulsivity score by the Urgency measured during fMRI [at baseline]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.