NCT01909960已完成不适用
Benefit of Flow Magnetic Resonance Imaging in the Management of Normal Pressure Hydrocephalus
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 4
- 主要终点
- cerebrospinal fluid (CSF) stroke volume evolution other 6 months
研究概览
简要总结
Normal pressure hydrocephalus diagnosis based on quantitative study of cerebro-spinal fluid and blood flow by phase contrast magnetic resonance imaging.
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
- 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
- 否
入选标准
- •Ventricular dilation seen on morphological magnetic resonance imaging (MRI)
- •Walking disorder
- •Cognitive disorder
- •Participants gave their written informed consent
排除标准
- •Contra-indication to MRI
- •Obstructive tumoral hydrocephalus
- •Curatorship or tutorship
- •Pregnancy or lactation
- •No social assurance
研究组 & 干预措施
Surgery
Experimental
Patients who will undergo flow imaging and neurosurgery (shunting). (25% of the studied population)
干预措施: Flow imaging (Other)
Clinical follow-up
Experimental
Patients who will undergo flow imaging but not surgery (75% of the studied population)
干预措施: Flow imaging (Other)
结局指标
主要结局
cerebrospinal fluid (CSF) stroke volume evolution other 6 months
时间窗: Day 1 (baseline), Day 180
Measurement of cerebrospinal fluid (CSF) stroke volume via flow MRI at the Sylvius' aqueduct, pontine cistern and spinal spaces levels and determination of its evolution
次要结局
- Blood flow analysis : evolution other 6 months(Day 1 (baseline), Day 180)
- Larson's score evolution over 6 months(Day 1, Day 180)
- Neuropsychological test evolution over 6 months(Day1, Day 180)
- Blood flow analysis : evolution other one year(Day 1 (baseline) and Day 365)
- Larson's score evolution over one year(Day 1 and Day 365)
- Neuropsychological test evolution over one year(Day1, Day 365)
- cerebrospinal fluid (CSF) stroke volume evolution other one year(Day1 (baseline), Day 365)
研究者
研究点 (4)
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