ETV Versus Shunt Surgery in Normal Pressure Hydrocephalus

Terminated

• Conditions: Hydrocephalus
• Interventions: Procedure: Ventriculoperitoneal Shunt Placement; Procedure: Endoscopic Third Ventriculostomy(ETV)

• Registration Number: NCT00946127
• Lead Sponsor: Johns Hopkins University

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 Description

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.

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-07-23
• Study First Submitted QC: 2009-07-23
• Study First Posted: 2009-07-24
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-01
• Last Update Posted: 2012-10-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• 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.
• MMSE>24
• Informed consent from patient

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Shunt Arm	Ventriculoperitoneal Shunt Placement	Ventriculoperitoneal Shunt
ETV arm	Endoscopic Third Ventriculostomy(ETV)	Endoscopic Third Ventriculostomy

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States