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

Narcolepsy Clinical Trial

— NC-TCSP-IRMf  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03425214
• Other study ID #: CHU-375
• Secondary ID: 2017-A01974-49
• Status: Recruiting
• Phase: N/A
• First received: February 1, 2018
• Last updated: February 8, 2018
• Start date: January 19, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: February 2018
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 11 95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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".

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cataplexy
• Mental Disorders
• Narcolepsy
• REM Sleep Behavior Disorder

Intervention

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

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	CH MONTLUCON, CH Vichy

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	reaction time to the task		at Month 1
Secondary	performance score to the task		at Month 1
Secondary	Beck Depression Inventory score measured during fMRI		at baseline
Secondary	Lille Apathy Rating Scale score measured during fMRI		at baseline
Secondary	impulsivity score by the Urgency measured during fMRI		at baseline