Endoscopic Third Ventriculostomy Versus Ventriculo-peritoneal Shunting in Idiopathic Normal Pressure Hydrocephalus
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Recovery Index
研究概览
简要总结
An endoscopic third ventriculostomy is considered to be successful in idiopathic normal pressure hydrocephalus (iNPH) in some literature reports, but there is a lack of high quality data. The aim of the present study is to compare the treatment options of iNPH (Endoscopic third ventriculostomy versus ventriculo-peritoneal shunt) in a randomized, controlled, multicenter study.
详细描述
The traditional treatment for communicating hydrocephalus is a ventriculo-peritoneal shunt insertion and the endoscopic third ventriculostomy (ETV) is reserved for patients with obstructive hydrocephalus. However, in the last decade several reports highlighted an success of an ETV in communicating hydrocephalus as well. Thus, the aim of the present study is to compare ventriculo-peritoneal shunting against ETV in patients with an idiopathic normal pressure hydrocephalus, an subset of communicating hydrocephalus, in a randomized, controlled multicenter study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 50 years
- •gait disturbances typical for iNPH
- •symptoms Duration less than 36months
- •exclusion of obstructive hydrocephalus
- •positive spinal TAP-test
排除标准
- •no informed consent
- •malignant disease
- •other diseases of the CNS (Parkinson, dementia)
- •secondary communicating hydrocephalus
结局指标
主要结局
Recovery Index
时间窗: 1 year
Improvment of at least 2 points
Kiefer Index
时间窗: 1 year
Improvment of at least 2 points
次要结局
未报告次要终点
研究者
Sascha Marx
Principal Investigator
University Medicine Greifswald