Endoscopic Third Ventriculostomy (ETV) Versus Ventriculoperitoneal Shunting (VPS) for the Surgical Management of Normal Pressure Hydrocephalus
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Johns Hopkins University
- Enrollment
- 13
- Locations
- 1
- Primary Endpoint
- Efficacy: Cognitive outcomes using RAVLT scale. Gait Outcomes evaluated based on Tinneti Gait and Balance Test. Functional Independence evaluated using Barthel index.
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •Informed consent from patient
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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)
Investigators
Daniele Rigamonti
Professor
Johns Hopkins University