White Matter Hyperintensities Subtypes in Cerebral Small Vessel Disease : 7 Tesla Ultra-high Resolution Imaging MRI
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Percentage of patients with a different form of white matter hyperintensities (WMH)
研究概览
简要总结
Cerebral small vessel diseases (SVD) are a very frequent group of disorders all characterized by alterations of the structure and/or function of small arteries, veins and capillaries. In these disorders, brain tissue lesions accumulate years before the occurrence of clinical symptoms which can be devastating such as stroke, cognitive disturbances and gait disorders. So far, chronic hypoperfusion was considered to be responsible for the accumulation of such lesions. However, recent results have suggested that the lesions underlying white matter hyperintensities (WMH), the most common MRI marker of SVD visible on conventional MRI in quite every subject with SVD long before the occurrence of clinical events, may depend on the considered brain area and may correspond to various mechanisms. Some WMH may even be associated with less severe clinical manifestations.The aim of the present study is to identify different types of WMH by studying 100 patients with different forms of SVD with the most advanced MRI (including ultra-high-resolution imaging at 7 Tesla, new diffusion protocol, sodium MRI, contrast-enhanced angiography and relaxometry and post-processing techniques), and post-processing techniques (machine learning, deep learning, artificial intelligence).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects or patients with MRI defined cerebral small vessel disease including different extents of white matter hyperintensities, presumably related to hypertension (30 patients), cerebral amyloid angiopathy (30 patients), CADASIL (30 patients) or any other monogenic form of cerebral small vessel disease (HTRA1 AD, COLIVA1... 10 patients)
- •Age ≥ 18 years
- •No dementia (MMSE > 24 and absence of dependence in daily activities)
- •No disability (modified Rankin's scale < 2)
- •No history of severe allergic reaction, in particular to gadolinium infusion
- •No history of severe asthma
- •No renal insufficiency (clearance < 60 ml/mn/1.73 m2)
排除标准
- •Contraindications to MRI
- •Standard MRI of bad quality due to movement artefacts
- •Dementia or disability
- •Patient without affiliation to the French social security
结局指标
主要结局
Percentage of patients with a different form of white matter hyperintensities (WMH)
时间窗: at the time of specific imaging (between Day 1 to Day 60)
The different forms of white matter hyperintensities will be assessed and identified using MRI imaging.The pattern of co-variation of structural, functional, metabolic imaging modalities, estimated in each voxel of a reference space, both inside and outside the WMH, will be compared through massive statistical approaches, controlled, for multiple testing
次要结局
- Frequency of large tract involvement(at the time of specific imaging (between Day 1 to Day 60))
- Global cognitive function(at inclusion)
- Language(at inclusion)
- Working memory(at inclusion)
- Attentional Performances status(at inclusion)
- Apathy status(at inclusion)
- Frequency of different WMH subtypes in different types of small cerebral vessel disease(at the time of specific imaging (between Day 1 to Day 60))
- Visual memory(at inclusion)
- Episodic verbal memory(at inclusion)
- Depression and Anxiety status(at inclusion)
- Pulse wave Velocity count(at inclusion)
- Spatial exploration(at inclusion)
- Spatial memory(at inclusion)
- Executive function(at inclusion)