Exploration of the Reward System by Functional MRI in Narco-cataplexy Patients With and Without REM Sleep Behavior Disorder
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Measure of BOLD signal variation in each region of interest
研究概览
简要总结
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.
详细描述
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 :
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- 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
排除标准
- •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/
- •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.
研究组 & 干预措施
NC with RBD
fMRI and video polysmnography
干预措施: fMRI (Other)
NC with RBD
fMRI and video polysmnography
干预措施: Videopolysomnography (Other)
NC without RBD
fMRI and video polysomnography
干预措施: NC (narcolepsy-cataplexy) (Other)
control group (healthy subjects)
fMRI
干预措施: fMRI (Other)
结局指标
主要结局
Measure of BOLD signal variation in each region of interest
时间窗: at Month 1
BOLD signal variation in each region of interest (ventral tegmental area, accumbens nucleus, limbic cortex, prefrontal cortex) measured during fMRI
次要结局
- performance score to the task(at Month 1)
- Lille Apathy Rating Scale score measured during fMRI(at baseline)
- reaction time to the task(at Month 1)
- Beck Depression Inventory score measured during fMRI(at baseline)
- impulsivity score by the Urgency measured during fMRI(at baseline)