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 range85 Years

SexALL

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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.

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