ISRCTN13838310已完成未知
Multicentre randomized trial evaluating the efficacy and safety of programmable compared with fixed anti-siphon devices for idiopathic normal pressure hydrocephalus (iNPH) in adults
nfallkrankenhaus Berlin0 个研究点目标入组 306 人开始时间: 2016年11月10日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 306
研究概览
简要总结
2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/30333067 protocol
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged 18 years and over
- •2. Meet clinical, physiological, functional and radiological diagnostic criteria of iNPH
- •2. Scheduled for VP shunting
- •4. Capable to understand the trial concept and its implications, and to provide written (or witnessed verbal) informed consent
排除标准
- •1. Secondary NPH after infection, trauma, tumours, etc.
- •2. Contraindication for shunt surgery (e.g., malignant disease with reduced life expectancy, florid infections etc.)
- •3. Advanced dementia
- •4. Guardianship
- •5. Any impediment prohibiting informed consent
- •6. Patients with previous shunt implantation
- •7. Patients with previous ventriculostomy
研究者
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