Endoscopic Third Ventriculostomy Versus Ventriculo-peritoneal Shunting in Idiopathic Normal Pressure Hydrocephalus

Study Overview
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Brief Summary
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An endoscopic third ventriculostomy is considered to be successful in idiopathic normal pressure hydrocephalus (iNPH) in some literature reports, but there is a lack of high quality data. The aim of the present study is to compare the treatment options of iNPH (Endoscopic third ventriculostomy versus ventriculo-peritoneal shunt) in a randomized, controlled, multicenter study.

Detailed Description
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The traditional treatment for communicating hydrocephalus is a ventriculo-peritoneal shunt insertion and the endoscopic third ventriculostomy (ETV) is reserved for patients with obstructive hydrocephalus. However, in the last decade several reports highlighted an success of an ETV in communicating hydrocephalus as well. Thus, the aim of the present study is to compare ventriculo-peritoneal shunting against ETV in patients with an idiopathic normal pressure hydrocephalus, an subset of communicating hydrocephalus, in a randomized, controlled multicenter study.

Official Title
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Endoscopic Third Ventriculostomy Versus Ventriculo-peritoneal Shunting in Idiopathic Normal Pressure Hydrocephalus

Conditions
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Normal Pressure Hydrocephalus

Intervention / Treatment
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* Procedure: Endoscopic Third Ventriculostomy
* Procedure: Ventriculo-Peritoneal Shunting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age over 50 years gait disturbances typical for iNPH symptoms Duration less than 36months exclusion of obstructive hydrocephalus positive spinal TAP-test Exclusion Criteria: no informed consent malignant disease other diseases of the CNS (Parkinson, dementia) secondary communicating hydrocephalus

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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: endoscopic third ventriculostomy<br>endoscopic third ventriculostomy for the treatment of iNPH | Procedure: Endoscopic Third Ventriculostomy<br>* patients receive an endoscopic third ventriculotomy as surgical procedure<br>|
| Active Comparator: ventricular peritoneal shunt<br>Insertion of a ventriculo-peritoneal Shunt for the treatment of iNPH | Procedure: Ventriculo-Peritoneal Shunting<br>* patients receive an ventriculo-peritoneal shunt as surgical procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kiefer Index | Improvment of at least 2 points | 1 year | 
| Recovery Index | Improvment of at least 2 points | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endoscopic third ventriculostomy, ventricular peritoneal shunt, communicating hydrocephalus