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

Normal Pressure Hydrocephalus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03245138
• Other study ID #: ETV versus VPS in iNPH
• Status: Recruiting
• Phase: N/A
• Start date: June 2016
• Est. completion date: December 2020

Study information

• Verified date: November 2018
• Source: University Medicine Greifswald
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2020
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hydrocephalus
• Hydrocephalus, Normal Pressure
• Normal Pressure Hydrocephalus

Intervention

Procedure:
• Endoscopic Third Ventriculostomy
patients receive an endoscopic third ventriculotomy as surgical procedure
• Ventriculo-Peritoneal Shunting
patients receive an ventriculo-peritoneal shunt as surgical procedure

Locations

Country	Name	City	State
Germany	University Medicine Göttingen	Göttingen
Germany	University Medicine Greifswald	Greifswald
Germany	Klinikum Neubrandenburg	Neubrandenburg

Sponsors (1)

Lead Sponsor	Collaborator
University Medicine Greifswald

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kiefer Index	Improvment of at least 2 points	1 year
Primary	Recovery Index	Improvment of at least 2 points	1 year