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

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.

Study Overview

• Status: Unknown
• Conditions: Narcolepsy; Cataplexy
• Intervention / Treatment: Other: fMRI; Other: Videopolysomnography; Other: NC (narcolepsy-cataplexy)

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 Type: Interventional
• Enrollment (Anticipated): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • Recruiting
    • CHU Clermont-Ferrand
    • Principal Investigator: Maria-Livia FANTINI
    • Sub-Investigator: Nicolas VITELLO
    • Sub-Investigator: Marcel MAILLET-VIOUF

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / 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".

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: Jacques Lacarin Hospital Center; CH Montluçon

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 19, 2018
• Primary Completion (ANTICIPATED): June 30, 2019
• Study Completion (ANTICIPATED): June 30, 2019

Study Registration Dates

• First Submitted: February 1, 2018
• First Submitted That Met QC Criteria: February 1, 2018
• First Posted (ACTUAL): February 7, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 9, 2018
• Last Update Submitted That Met QC Criteria: February 8, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: functional MRI; REM sleep behaviour disorder; Reward system; Narco-cataplexy
• Additional Relevant MeSH Terms: Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; REM Sleep Parasomnias; Disorders of Excessive Somnolence; Mental Disorders; REM Sleep Behavior Disorder; Narcolepsy; Cataplexy
• Other Study ID Numbers: CHU-375; 2017-A01974-49 (OTHER: 2017-A01974-49)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No