Exploration of the Reward System by Functional MRI in Narco-cataplexy Patients With and Without REM Sleep Behavior Disorder
NCT ID: NCT03425214
Last Updated: 2018-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
66 participants
INTERVENTIONAL
2018-01-19
2019-06-30
Brief Summary
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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.
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Detailed Description
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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".
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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NC with RBD
fMRI and video polysmnography
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 without RBD
fMRI and video polysomnography
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.
control group (healthy subjects)
fMRI
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".
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
Yes
Sponsors
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CH MONTLUCON
UNKNOWN
Jacques Lacarin Hospital Center
OTHER
University Hospital, Clermont-Ferrand
OTHER
Responsible Party
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Principal Investigators
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Maria-Livia FANTINI
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Clermont-Ferrand
Locations
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CHU Clermont-Ferrand
Clermont-Ferrand, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2017-A01974-49
Identifier Type: OTHER
Identifier Source: secondary_id
CHU-375
Identifier Type: -
Identifier Source: org_study_id
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