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

U

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

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

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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