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

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.

Study Overview

• Status: Unknown
• Conditions: Normal Pressure Hydrocephalus
• Intervention / Treatment: Procedure: Endoscopic Third Ventriculostomy; Procedure: Ventriculo-Peritoneal Shunting

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Greifswald, Germany, 17489
    • Recruiting
    • University Medicine Greifswald
    • Contact: Sascha Marx, MD; Phone Number: 00493834866163; Email: marxs@uni-greifswald.de
    • Contact: Henry WS Schroeder, MD, PhD; Phone Number: 00493834866163; Email: henry.schroeder@uni-greifswald.de
  • Göttingen, Germany
    • Not yet recruiting
    • University Medicine Gottingen
    • Contact: Ingo Fiss, MD; Email: ingo.fiss@med.uni-goettingen.de
    • Contact: Veit Rohde, MD, PhD; Email: veit.rohde@med.uni-goettingen.de
  • Neubrandenburg, Germany
    • Recruiting
    • Klinikum Neubrandenburg
    • Contact: Aleksandra Smilgrin, MD; Email: smilgina@dbknb.de
    • Contact: Michael Fritsch, MD, PhD; Email: fritschm@dbknb.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Medicine Greifswald

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: July 31, 2017
• First Submitted That Met QC Criteria: August 7, 2017
• First Posted (Actual): August 10, 2017

Study Record Updates

• Last Update Posted (Actual): November 6, 2018
• Last Update Submitted That Met QC Criteria: November 5, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: endoscopic third ventriculostomy; ventricular peritoneal shunt; communicating hydrocephalus
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hydrocephalus; Hydrocephalus, Normal Pressure
• Other Study ID Numbers: ETV versus VPS in iNPH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No