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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03245138
Other study ID # ETV versus VPS in iNPH
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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