Endoscopic Third Ventriculostomy vs. Ventriculoperitoneal Shunt in Idiopathic Normal Pressure Hyd… (NCT06488248) | Clinical Trial Compass
RecruitingNot Applicable
Endoscopic Third Ventriculostomy vs. Ventriculoperitoneal Shunt in Idiopathic Normal Pressure Hydrocephalus (ENDOVEST)
Switzerland150 participantsStarted 2025-01-17
Plain-language summary
The aim of this single-center, two-arm, open-labeled, randomized controlled clinical study is to compare two surgical interventions, endoscopic third ventriculostomy and ventriculoperitoneal shunt, in treating idiopathic normal pressure hydrocephalus in terms of clinical improvement.
Who can participate
Age range
40 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:
* \>40 years of age
* Symptom duration ≥3 months, \<24 months
* No antecedent head trauma, ICH, meningitis, or other cause of secondary hydrocephalus
* MUST show gait/balance disturbance, PLUS cognition impairment AND/OR urinary dysfunction.
* Ventricular enlargement (Evans Index \> 0.3) not attributable to cerebral atrophy or congenital enlargement
* No macroscopic obstruction to cerebrospinal fluid (CSF) flow Spinal Tap-Test
* Opening pressure (on lateral decubitus): \<24cmH2O
* Clinical improvement in at least one of the main symptoms after 40-50ml withdrawal of CSF
Exclusion Criteria:
* ≤40 years of age
* No informed consent
* Other neurologic, psychiatric or general medical condition which is sufficient to explain the presenting symptoms.
* Previous cranial neurosurgical interventions
* Other associated dementia syndromes
* Incapacity to walk
* Pregnancy and breastfeeding women
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
1
idiopathic normal pressure hydrocephalus (iNPH) score
Timeframe: Before surgery (baseline), up to 5 days, 2, 6, and 12 months after surgery