Exploration of the Reward System by Functional MRI in Parkinson's Disease Patients With and Without REM Sleep Behavior Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- BOLD signal variation in each region of interest
研究概览
简要总结
Up to 60% of Parkinson's Disease (PD) patients suffer from REM sleep behavior disorder (RBD), a parasomnia. This disorder is thought to be related to a dysfunction of limbic system and brainstem.
Impulse control disorders (ICD) are found in about 14% of PD patients taking dopaminergic drugs. These disorders are thought to be related to a dysfunction of meso-cortico-limbic pathways which belong to the so-called "reward system".
A strong link was found between these two disorders and therefore the investigators believe that RBD is associated with impaired reward system.
The main objective of this study is to evaluate differences in brain activation between PD patients with and without RBD.
The investigators hypothesize that PD patients with RBD have a more severe dysfunction of the reward system (hypoactivation of the meso-cortico-limbic pathway) than patients without RBD, explaining their susceptibility to ICD when exposed to high doses of dopaminergic treatment.
详细描述
Type of study: Prospective, case control study.
Number of centers: 2 (Clermont-Ferrand and Vichy)
Patients :
The study will be performed in 75 subjects (25 PD patients with RBD, 25 PD patients without RBD and 25 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
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parkinson's disease (UK Parkinson's Disease Society Brain Bank Criteria)
- •men or women 45 to 80 years old
- •diagnosis of RBD made with polysomnographic recording
排除标准
- •Previous history of psychosis or psychiatric disease
- •History of stroke or vascular lesion on MRI.
- •pregnant women
结局指标
主要结局
BOLD signal variation in each region of interest
时间窗: at week 1
BOLD signal variation in each region of interest (ventral tegmental area, accumbens nucleus, limbic cortex, prefrontal cortex) at the time of realisation of fMRI.
次要结局
- The Beck Depression Inventory score(at week 1)
- The impulsivity score by the Urgency(at week 1)
- The Unified Parkinson Disease Rating scale (MDS-UPDRS) score(at week 1)
- Hoehn et Yahr score(at week 1)
- Reaction time to the task(at week 1)
- Performance score to the task(at week 1)
- The Lille Apathy Rating Scale score(at week 1)