CompletedNot Applicable

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

Netherlands58 participantsStarted 2003-09

Plain-language 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.

Who can participate

Age range

85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * At least two out of three of the typical signs of normal pressure hydrocephalus: * gait disturbance, * cognitive impairment and * urinary incontinence. * Radiological verification of a communicating hydrocephalus. * Cerebrospinal fluid pressure at lumbar puncture \< 150 mm H2O. Exclusion Criteria: * Aqueduct stenosis. * Severe comorbidity. * Age \> 85 years. * Possibly confounding neurological diseases. * Recent meningitis or subarachnoid hemorrhage.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

the number of Subdural effusions, detected on CT scan, in patients showing clinical improvement after implantation of a ventriculoperitoneal shunt,at the end of the study

Timeframe: baseline and 9 months (end of study)

Trial details

NCT IDNCT01570257

SponsorErasmus Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2006-12

View on ClinicalTrials.gov More Idiopathic Normal Pressure Hydrocephalus trials