Clinical Trial: ETV Versus Shunt Surgery in Normal Pressure Hydrocephalus

Study Status: Terminated
Recruit Status: Terminated
Study Type: Observational

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

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Johns Hopkins University

Current Primary Outcome:

  • Efficacy: Cognitive outcomes using RAVLT scale. Gait Outcomes evaluated based on Tinneti Gait and Balance Test. Functional Independence evaluated using Barthel index. [ Time Frame: 1, 3, 6, 12 months after surgery ]
  • Safety [ Time Frame: 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


Original Primary Outcome:

  • Efficacy: Cognitive outcomes using RAVLT scale. Gait Outcomes evaluated based on Tinneti Gait and Balance Test. Functional Independance evaluated using Barthel index. [ Time Frame: 1, 3, 6, 12 months after surgery ]
  • Safety [ Time Frame: 0 through 12 months from Surgery ]


Current Secondary Outcome: Efficacy: Cognitive changes using Trails A& B. Gait changes based upon Timed Up and Go task and Gait Rite analysis. [ Time Frame: 1 months, 3 months, 6 months and 1 year ]

Original Secondary Outcome: Same as current

Information By: Johns Hopkins University

Dates:
Date Received: July 23, 2009
Date Started: March 2009
Date Completion:
Last Updated: October 1, 2012
Last Verified: October 2012