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

NACompletedINTERVENTIONAL
Enrollment

58

Participants

Timeline

Start Date

September 30, 2003

Primary Completion Date

December 31, 2006

Study Completion Date

October 31, 2007

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.

Trial Locations (1)

3015 CA

Erasmus Medical Center, Rotterdam

Sponsors
All Listed Sponsors
collaborator

Isala

OTHER

collaborator

Albert Schweitzer Hospital

OTHER

collaborator

UMC Utrecht

OTHER

collaborator

Atrium Medical Center

OTHER

collaborator

University Medical Center Nijmegen

OTHER

collaborator

Admiraal de Ruyter Hospital

OTHER

collaborator

Medtronic

INDUSTRY

lead

Erasmus Medical Center

OTHER

NCT01570257 - A Trial of High and Low Pressure Level Settings on a Programmable Ventriculoperitoneal Shunt Valve for Idiopathic Normal Pressure Hydrocephalus | Biotech Hunter | Biotech Hunter