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

University Medicine Greifswald

Status: Unknown

Conditions: Normal Pressure Hydrocephalus

Treatments: Procedure: Endoscopic Third Ventriculostomy; Procedure: Ventriculo-Peritoneal Shunting

Study type: Interventional

Funder types: Other

Identifiers

NCT03245138

ETV versus VPS in iNPH

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

endoscopic third ventriculostomy

Experimental group

Description:

endoscopic third ventriculostomy for the treatment of iNPH

Treatment:

Procedure: Endoscopic Third Ventriculostomy

ventricular peritoneal shunt

Active Comparator group

Description:

Insertion of a ventriculo-peritoneal Shunt for the treatment of iNPH

Treatment:

Procedure: Ventriculo-Peritoneal Shunting