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

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ClinicalTrials.gov Identifier: NCT03425214
Recruitment Status : Recruiting
First Posted : February 7, 2018
Last Update Posted : February 9, 2018
Sponsor:
Collaborators:
CH MONTLUCON
CH Vichy
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

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) Not Applicable

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  (Clinical Trial)
Estimated 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 : January 19, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


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".




Primary Outcome Measures :
  1. Measure of BOLD signal variation in each region of interest [ Time Frame: 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 :
  1. reaction time to the task [ Time Frame: at Month 1 ]
  2. performance score to the task [ Time Frame: at Month 1 ]
  3. Beck Depression Inventory score measured during fMRI [ Time Frame: at baseline ]
  4. Lille Apathy Rating Scale score measured during fMRI [ Time Frame: at baseline ]
  5. impulsivity score by the Urgency measured during fMRI [ Time Frame: at baseline ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03425214


Contacts
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
France
CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Principal Investigator: Maria-Livia FANTINI         
Sub-Investigator: Nicolas VITELLO         
Sub-Investigator: Marcel MAILLET-VIOUF         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
CH MONTLUCON
CH Vichy
Investigators
Principal Investigator: Maria-Livia FANTINI University Hospital, Clermont-Ferrand

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT03425214     History of Changes
Other Study ID Numbers: CHU-375
2017-A01974-49 ( Other Identifier: 2017-A01974-49 )
First Posted: February 7, 2018    Key Record Dates
Last Update Posted: February 9, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Clermont-Ferrand:
functional MRI
Reward system
REM sleep behaviour disorder
Narco-cataplexy

Additional relevant MeSH terms:
Narcolepsy
Mental Disorders
REM Sleep Behavior Disorder
Cataplexy
Disorders of Excessive Somnolence
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
REM Sleep Parasomnias
Parasomnias