Evaluation and Validation of a Multimodal MRI Neuroimaging Method: Application to Differential Diagnosis and Disease Progression in Parkinsonian Syndromes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- The primary outcome measure to discriminate individual patients and patients with MPI and AMS through multimodal MRI isolating multiparametric spatial signature resulting from a combination of markers in multimodal imaging.
研究概览
简要总结
Based on previous promising results, the next step for the validation of a multimodal MRI method in diagnosis and follow up of patients reached by parkinsonian syndromes is (i) to test whether the multimodal neuroimaging is able to discriminate at the individual level, patients with multiple system atrophy parkinsonism (MSA) and patients with idiopathic Parkinson's disease (PD) (ii) to determine whether the method is sensitive to measure changes over time for the two diseases, according to imaging, neuropsychological and other clinical data. Patients will be compared with healthy controls.
详细描述
30 patients with PD, 30 patients with MSA and 30 healthy controls will be examined in a 3Tesla MRI.
The aim of our project is to demonstrate that our multimodal MRI method can discriminate both diseases with a similar clinical presentation and monitor the progress of the disease. CIC's expertise in recruitment and assessment of patients, and the powers of the INSERM U825 in terms of development and processing in neuroimaging guarantee the feasibility of the project and its successful completion.
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
- 否
入选标准
- •informed consent signed
- •right handed patients
- •Mini Mental Score > 22
- •no other neurological disease than Parkinson's Disease (PD) or Multiple System Atrophy (MSA)
- •non-demented patients reached by PD or MSA (according to diagnosis criteria from UK PD Brain Bank and from Gilman and colleagues, 1998, for PD and MSA respectively)
- •for PD patients only : Hoehn and Yahr score from 2 to 3
排除标准
- •claustrophobia
- •contraindications to MRI (cardiac or auditive prothesis, pacemakers, cerebral clip, stimulating electrodes)
- •pregnant women
- •major neuropsychiatric disease
- •refusal to be informed in case of cerebral anomaly detected during MRI acquisition
- •uncompensated thyroid deficit
结局指标
主要结局
The primary outcome measure to discriminate individual patients and patients with MPI and AMS through multimodal MRI isolating multiparametric spatial signature resulting from a combination of markers in multimodal imaging.
时间窗: 1 year
次要结局
- correlate MP and MSA disease severity with extracted multimodal MRI biomarkers in whole brain(1 year)