A Trial of High and Low Pressure Level Settings on a Programmable Ventriculoperitoneal Shunt Valve for Idiopathic Normal Pressure Hydrocephalus

Summary

In treating idiopathic normal pressure hydrocephalus with a shunt there is always a risk of underdrainage or overdrainage. The hypothesis is tested whether treatment of patients with an adjustable valve preset at the highest opening pressure (OPV), leads to comparable clinical results with less subdural effusions than in a control group with an opening pressure preset and kept fixed at a low pressure level.

Conditions

• Idiopathic Normal Pressure Hydrocephalus

Interventions

PROCEDURE

lowering of the performance level of an adjustable Strata valve in a ventriculoperitoneal (VP) shunt for treating idiopathic normal pressure hydrocephalus

in the intervention group, the performance level(PL) of the valve of the VP shunt, preset at the highest PL (meaning highest resistance) is lowered stepwise in the follow-up period at 1,3 and 9 months postoperatively after implantation until improvement occurs or signs of overdrainage are encountered on a new CT scan of the brain. In the control group the PL is preset and fixed at the second lowest PL and these patients serve as a control group.

Sponsors & Collaborators

• Isala

  collaborator OTHER

• Albert Schweitzer Hospital

  collaborator OTHER

• UMC Utrecht

  collaborator OTHER

• Atrium Medical Center

  collaborator OTHER

• University Medical Center Nijmegen

  collaborator OTHER

• Admiraal de Ruyter Hospital

  collaborator OTHER

• Medtronic

  collaborator INDUSTRY

• Erasmus Medical Center

  lead OTHER

Principal Investigators

• Clemens MF Dirven, Prof. PhD · Erasmus Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2003-09-30

Primary Completion

2006-12-31

Completion

2007-10-31

Countries

• Netherlands

Study Locations