Exploration of Mesocorticolimbic Pathway in Impulse Control Disorders in Parkinson's Disease: Study Using Tensor Diffusion Imaging and Tractography.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Fractional anisotropy (data of diffusion tensor imaging, a technique of MRI)
研究概览
简要总结
Impulse control disorders (ICD) are frequent in Parkinson's Disease. Neurobiological substrates of these symptoms are largely unknown.
The investigators aim to explore mesocorticolimbic pathway in Parkinson's disease patients with impulse control disorders (ICD) using an MRI technique called tensor diffusion imaging (DTI).
More precisely, the main purpose is to demonstrate that fractional anisotropy (FA) (data obtained with DTI) in the ventral tegmental area (VTA) is different between patients with ICD and patients without ICD. Secondary objectives are to demonstrate a difference in volume of VTA, in FA in others structures included in reward system (prefrontal cortex, nucleus accumbens, amygdala), and in number of fibers between VTA and the other structures of reward system between this two groups. Other objective is to measure and compare these same variables between Parkinson's patients and healthy controls.
We hypothesized that a denervation of mesocorticolimbic pathway predisposes Parkinson's patients to ICD.
详细描述
Type of study: Prospective, case control study.
Number of centers: 1 (Clermont-Ferrand)
Patients :
Inclusion of 25 patients with Parkinson's disease and impulse control disorders (inclusion's criteria detailed later), 25 matched Parkinson's disease patients without impulse control disorders and 25 healthy volunteers.
Study Performance :
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 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)
- •from 18 to 85 years old
- •Impulse control disorder (one item ICD ≥2 at the scale ECMP : Evaluation Comportementale de la maladie de Parkinson)
排除标准
- •Dementia (Mini Mental State < 26 or MATTIS < 130)
- •Apathy (LARS (Lille Apathy Rating Scale) > 7)
- •Depression (MADRS (Montgomery and Alsberg Depression Scale) ≥16
- •Contra indication to MRI (claustrophobia, deep brain stimulation, pace maker...)
结局指标
主要结局
Fractional anisotropy (data of diffusion tensor imaging, a technique of MRI)
时间窗: 1 day
次要结局
- Fractional anisotropy in préfrontal cortex(1 day)
- Volume of ventral tegmental area(1 day)
- Number of fibers between ventral tegmental area and other structures of the reward system(1 day)