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临床试验/NCT00946127
NCT00946127终止不适用

Endoscopic Third Ventriculostomy (ETV) Versus Ventriculoperitoneal Shunting (VPS) for the Surgical Management of Normal Pressure Hydrocephalus

Johns Hopkins University1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2009年3月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
13
试验地点
1
主要终点
Efficacy: Cognitive outcomes using RAVLT scale. Gait Outcomes evaluated based on Tinneti Gait and Balance Test. Functional Independence evaluated using Barthel index.

研究概览

简要总结

The purpose of this study is to test and compare the efficacy of Endoscopic Third Ventriculostomy with shunting of Cerebrospinal fluid (CSF)for treatment for patients of Normal pressure Hydrocephalus.

详细描述

Normal pressure Hydrocephalus is a reversible disorder of cognition and gait disorder.Currently the shunting of CSF is the recommended treatment of these patients. Even though shunts are known to be beneficial treatment of Hydrocephalus they often need treatment or revision for infection or malfunction. Endoscopic Third Ventriculostomy is a treatment without complications of shunt and is known to benefit obstructive forms of hydrocephalus.Few studies have also shown that it may be efficacious treatment Normal pressure Hydrocephalus.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with NPH
  • Meet at least 2 of 3 Hakim and Adams diagnostic criterion for NPH (dementia, gait instability and urinary incontinence)
  • Ventriculomegaly defined by CT or MRI, Evans' index > 0.3
  • Clinical improvement after 3 day trial of CSF drainage.
  • Informed consent from patient

排除标准

  • 未提供

结局指标

主要结局

Efficacy: Cognitive outcomes using RAVLT scale. Gait Outcomes evaluated based on Tinneti Gait and Balance Test. Functional Independence evaluated using Barthel index.

时间窗: 1, 3, 6, 12 months after surgery

Safety

时间窗: 0 through 12 months from Surgery

Incidence of operative complications related to insertion of a shunt or performing ETV Intra-operative hemorrhage Post Operative amnesia Post Operative hemorrhage Infections Others Incidence of complications related to either of the two procedure over long term follow-up Infection Shunt malfunction ETV closure Others

次要结局

  • Efficacy: Cognitive changes using Trails A& B. Gait changes based upon Timed Up and Go task and Gait Rite analysis.(1 months, 3 months, 6 months and 1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniele Rigamonti

Professor

Johns Hopkins University

研究点 (1)

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