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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03245138

Enrollment

100

Registered

2017-08-10

Start date

2016-06-30

Completion date

2020-12-31

Last updated

2018-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Normal Pressure Hydrocephalus

Keywords

endoscopic third ventriculostomy, ventricular peritoneal shunt, communicating hydrocephalus

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.

Interventions

PROCEDUREEndoscopic Third Ventriculostomy

patients receive an endoscopic third ventriculotomy as surgical procedure

PROCEDUREVentriculo-Peritoneal Shunting

patients receive an ventriculo-peritoneal shunt as surgical procedure

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Kiefer Index	1 year	Improvment of at least 2 points
Recovery Index	1 year	Improvment of at least 2 points

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026