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临床试验/NCT01794195
NCT01794195已完成不适用

Role of Mesocorticolimbic Pathway in Apathy of Patients With Parkinson's Disease. - Study Using Diffusion Tensor Imaging and Fibres Tracking

University Hospital, Clermont-Ferrand2 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2013年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
63
试验地点
2
主要终点
Fractional anisotropy coefficient (the fractional anisotropy coefficient is computed from the eigenvalues of the diffusion tensor)

研究概览

简要总结

Use lay language.

Apathy is one of the most under recognised, underdiagnosed and poorly managed aspects of Parkinson's disease. Depending on methodological approach of the study, its prevalence is estimated to be between 16 and 51%.

Apathy derives from a dysfunction of the dopaminergic meso cortico limbic systems, which seems to play a central role in the control of mood and motivation. The subcortical components of this system are the ventral tegmental area (VTA), the nucleus accumbens, and the constituents of the limbic system (particularly the hippocampus and amygdala), all of which are located deep inside the brain (18). The hypothesis is that depletion of striatal dopamine from regulators located in the midbrain (VTA and SNpc) in striato-thalamo-cortical circuits results in hypofunction of these circuits and the loss of frontal cortical activity, particularly within in the frontal orbital cortex, the anterior cingulate cortex and the prefrontal cortex

The objective of this study is to explore, using diffusion weighted MRI, the regions of the brain which are proposed to play a role in motivation in apathetic Parkinson's disease patients and to define more precisely the relation between dopaminergic fibres and the meso-cortico-limbic system with the help of tractography methods

详细描述

3 groups :

  • 20 apathetic patients with Parkinson's disease
  • 20 non apathetic paired patients)
  • 20 healthy paired control

Description of the protocol for patients :

J0 : Inclusion visit (duration : 4h):

  • motor assessment (UPDRS)
  • neuropsychological and psychiatric assessment : Cognitive assessments : Mini Mental State MMS, MATTIS Apathy assessment: Apathy Inventory from Robert et al (2002); Lille apathy rating scale (LARS) ; Starkstein scale.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
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

入选标准

  • Men or women aged between 18 -85 years
  • Patients with an idiopathic Parkinson's disease according to UKPDSBB criterias
  • Non dement (MMS ≥ 26 ; MATTIS ≥ 130)
  • Affiliated to National Health system
  • Having given their informed consent
  • Healthy controls
  • Men or women aged between 18 -85 years
  • Affiliated to National Health system
  • Having given their informed consent

排除标准

  • Patients :
  • Patients suffering of an atypical Parkinson syndrome
  • Psychiatric pathology
  • Severe tremor form of PD
  • Depression (MADRS >16)., dementia (MMS < 26, MATTIS < 130).
  • Under guardianship
  • In excluding period for another study
  • Any contra-indication to MRI
  • Healthy subject
  • Subject with neurological, psychiatric diseases
  • Depression, dementia, apathy
  • Under guardianship
  • In excluding period for another study
  • Any contra-indication to MRI

结局指标

主要结局

Fractional anisotropy coefficient (the fractional anisotropy coefficient is computed from the eigenvalues of the diffusion tensor)

时间窗: at day 1

次要结局

  • Bulk diffusivity index(at day 1)
  • Apparent diffusion coefficient(at day 1)
  • Fibres density (number of fibres / voxel)(at day 1)

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (2)

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