Predictive Value of Flow MRI in Normal Pressure Hydrocephalus Surgery
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- CSF stroke volume
研究概览
简要总结
The idea is to assess the predictive value of flow magnetic resonance imaging (flow MRI) for patient suffering normal pressure hydrocephalus (NPH) planned for surgery. By now, the depletive lumbar puncture is the best test assessing the efficacy of a forthcoming surgery. The idea is to demonstrate that flow MRI can be as effective as lumbar puncture in term of predictive value of surgery response.
In that way, cerebrospinal fluid (CSF) dynamics are evaluated by a single non invasive examination. CSF flow is measured at the Sylvius' aqueduct, cervical, arachnoid space and 4th ventricle levels.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age: over 20 years
- •diagnostic of normal pressure hydrocephalus
- •ventricular dilation visible on radiological examination
- •patients gave their written informed consent
排除标准
- •age: less than 20 years
- •MRI contra-indication
- •pregnancy
- •lumbar puncture within 48 hours before MRI
- •cardiac arrhythmia
- •cerebral/lacunar stroke
研究组 & 干预措施
Normal pressure hydrocephalus
Hydrocephalus patients planned for shunting surgery. They will undergo clinical and imaging examinations at day 1, 3 months and 1 year after their surgery.
干预措施: clinical and imaging examinations (Other)
结局指标
主要结局
CSF stroke volume
时间窗: Day 1
Measurement of CSF stroke volume via flow MRI at the Sylvius' aqueduct level
次要结局
- Hakim's triad evaluation(Day 365)
- Neuropsychological test(Day 365)
- CSF stroke volume(Day 365)
- Hakim's triad evaluation(Day 1)
- Hakim's triad evaluation(Day 90)
- Neuropsychological test(Day 1)
- Neuropsychological test(Day 90)
- CSF stroke volume(Day 60)