Exploration of the Reward System by Functional MRI in Narco-cataplexy Patients With and Without REM Sleep Behavior Disorder (NC-TCSP-IRMf)
Primary Purpose
Narcolepsy, Cataplexy
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
fMRI
Videopolysomnography
NC (narcolepsy-cataplexy)
Sponsored by
About this trial
This is an interventional diagnostic trial for Narcolepsy focused on measuring functional MRI, Reward system, REM sleep behaviour disorder, Narco-cataplexy
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.
Sites / Locations
- CHU Clermont-FerrandRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
NC with RBD
NC without RBD
control group (healthy subjects)
Arm Description
fMRI and video polysmnography
fMRI and video polysomnography
fMRI
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
reaction time to the task
performance score to the task
Beck Depression Inventory score measured during fMRI
Lille Apathy Rating Scale score measured during fMRI
impulsivity score by the Urgency measured during fMRI
Full Information
NCT ID
NCT03425214
First Posted
February 1, 2018
Last Updated
February 8, 2018
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
CH MONTLUCON, Jacques Lacarin Hospital Center
1. Study Identification
Unique Protocol Identification Number
NCT03425214
Brief Title
Exploration of the Reward System by Functional MRI in Narco-cataplexy Patients With and Without REM Sleep Behavior Disorder
Acronym
NC-TCSP-IRMf
Official Title
Exploration of the Reward System by Functional MRI in Narco-cataplexy Patients With and Without REM Sleep Behavior Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 19, 2018 (Actual)
Primary Completion Date
June 30, 2019 (Anticipated)
Study Completion Date
June 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
CH MONTLUCON, Jacques Lacarin Hospital Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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".
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Narcolepsy, Cataplexy
Keywords
functional MRI, Reward system, REM sleep behaviour disorder, Narco-cataplexy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
66 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NC with RBD
Arm Type
Experimental
Arm Description
fMRI and video polysmnography
Arm Title
NC without RBD
Arm Type
Experimental
Arm Description
fMRI and video polysomnography
Arm Title
control group (healthy subjects)
Arm Type
Experimental
Arm Description
fMRI
Intervention Type
Other
Intervention Name(s)
fMRI
Intervention Description
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".
Intervention Type
Other
Intervention Name(s)
Videopolysomnography
Intervention Description
Video polysomnography will be perform in the sleep center during one night if patient did not have vPSG for 1 year.
Intervention Type
Other
Intervention Name(s)
NC (narcolepsy-cataplexy)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Measure of BOLD signal variation in each region of interest
Description
BOLD signal variation in each region of interest (ventral tegmental area, accumbens nucleus, limbic cortex, prefrontal cortex) measured during fMRI
Time Frame
at Month 1
Secondary Outcome Measure Information:
Title
reaction time to the task
Time Frame
at Month 1
Title
performance score to the task
Time Frame
at Month 1
Title
Beck Depression Inventory score measured during fMRI
Time Frame
at baseline
Title
Lille Apathy Rating Scale score measured during fMRI
Time Frame
at baseline
Title
impulsivity score by the Urgency measured during fMRI
Time Frame
at baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria-Livia FANTINI
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Maria-Livia FANTINI
First Name & Middle Initial & Last Name & Degree
Nicolas VITELLO
First Name & Middle Initial & Last Name & Degree
Marcel MAILLET-VIOUF
12. IPD Sharing Statement
Learn more about this trial
Exploration of the Reward System by Functional MRI in Narco-cataplexy Patients With and Without REM Sleep Behavior Disorder
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