ETV Versus Shunt Surgery in Normal Pressure Hydrocephalus

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hydrocephalus

Intervention / Treatment
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* Procedure: Ventriculoperitoneal Shunt Placement
* Procedure: Endoscopic Third Ventriculostomy(ETV)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Shunt Arm<br>Ventriculoperitoneal Shunt | Procedure: Ventriculoperitoneal Shunt Placement<br>* In the subjects who choose this arm, at the start of study- CSF (Cerebrospinal fluid ) will be shunted to peritoneum by placing a ventriculoperitoneal shunt catheter with or without shunt valves or anti-siphon device.<br>* Other names: Medtronic PS Strata Medical Valve--manufacturer-Medtronic Neurosurgery Inc;|
| ETV arm<br>Endoscopic Third Ventriculostomy | Procedure: Endoscopic Third Ventriculostomy(ETV)<br>* Patients who choose to undergo ETV arm would undergo a ventriculostomy at the start of study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 0 through 12 months from Surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Normal Pressure Hydrocephalus, Communicating Hydrocephalus, Gait disorder, Cognition, Shunt, Endoscopic Third Ventriculostomy.