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

Not Applicable

• Conditions: Normal Pressure Hydrocephalus
• Interventions: Procedure: Endoscopic Third Ventriculostomy; Procedure: Ventriculo-Peritoneal Shunting

• Registration Number: NCT03245138
• Lead Sponsor: University Medicine Greifswald

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2017-07-31
• Study First Submitted QC: 2017-08-07
• Study First Posted: 2017-08-10
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-05
• Last Update Posted: 2018-11-06
• Primary Completion: 2018-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
endoscopic third ventriculostomy	Endoscopic Third Ventriculostomy	endoscopic third ventriculostomy for the treatment of iNPH
ventricular peritoneal shunt	Ventriculo-Peritoneal Shunting	Insertion of a ventriculo-peritoneal Shunt for the treatment of iNPH

Primary Outcome Measures

Name	Time	Method
Recovery Index	1 year	Improvment of at least 2 points
Kiefer Index	1 year	Improvment of at least 2 points

Trial Locations

Locations (3)

University Medicine Greifswald; 🇩🇪 Greifswald, Germany

Klinikum Neubrandenburg; 🇩🇪 Neubrandenburg, Germany

University Medicine Göttingen; 🇩🇪 Göttingen, Germany