Innovative Biomarkers in de Novo Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- To compare emotional, attentional and behavior differences between subject
研究概览
简要总结
This study aims at identifying potential new and innovative biomarkers in de novo Parkinson's disease patients. New finding will help phenotyping patients since the diagnosis of the disease and potentially also in the preclinical phase.
详细描述
The investigators will use 4 different approaches in parallel:
- detailed clinical evaluation using the current available validated clinical scales and the Dopamine transporter (DAT) SPECT imaging;
- anatomical and perfusional brain evaluation using functional MRI;
- cortical brain mapping and transcranial magnetic stimulation assessment using a robotized approach;
- emotional responses study using a novel paradigm. These 4 modalities will be assessed at baseline, 1 year and 2 years follow-up.
The investigators will integrate these 4 analysis using a mathematical paradigm in order to define specific phenotype of disease and disease progression.
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
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parkinson's disease
- •Asymmetric bradykinesia and/or resting tremor and rigidity since less than 2.5 years ;
- •Hoehn & Yahr ≤ 2/5 ;
- •Montreal cognitive assessment ≥ 26/30 ;
排除标准
- •Treatment for Parkinson's disease (except selegiline and rasagiline)
- •Severe visual/retinal pathology revealed during ophthalmological assessment
- •Hyper-sensibility to gadolinium
- •Renal failure
- •Specific MRI contraindication
- •Specific TMS contraindication
结局指标
主要结局
To compare emotional, attentional and behavior differences between subject
时间窗: In a seven months period after inclusion
Subjects will be asked to comment on different pictures (if the picture induces pleasure, sorrow or nothing; what would the subjects do). Attentional parameters will be recorded using the Eye tracker.
To compare brain structural differences between subjects
时间窗: In a seven months period after inclusion
All subjects will have a 3 Tesla brain MRI to collect data concerning anatomy. All data will be compared between patients and controls. Brain MRI study will consist in having the following sequences: T1 and T2, Fast Gray Matter Acquisition T1 Inversion Recovery (FGATIR)
To compare brain perfusional differences between subjects
时间窗: In a seven months period after inclusion
All subjects will have a 3 Tesla brain MRI to collect data concerning perfusion. All data will be compared between patients and controls. Brain MRI study will consist in having the following sequences: Pseudo-Continuous Arterial Spin Labeling (PCASL), T2 with gadolinium, FLAIR
To compare cortical excitability differences between subjects
时间窗: In a seven months period after inclusion
The EEG data after transcranial magnetic stimulation testing will be compared between parkinsonian patients and controls
To compare brain connectivity differences between subjects
时间窗: In a seven months period after inclusion
All subjects will have a 3 Tesla brain MRI to collect data concerning functional connectivity at rest. All data will be compared between patients and controls. Brain MRI study will consist in having the following sequences: Echo planar imaging (EPI) for the blood oxygen level-dependent effect
To compare emotional, attentional and behavior differences between subject with functional MRI
时间窗: In a seven months period after inclusion
During a functional MRI study, subjects will be asked to comment on different pictures (if the picture induces pleasure, sorrow or nothing; what would the subjects do). Attentional parameters will be recorded using the Eye tracker.
次要结局
未报告次要终点