Comparing two surgical treatments for idiopathic normal pressure hydrocephalus
Official title: Endoscopic Third Ventriculostomy Compared to Ventriculoperitoneal Shunt as Treatment for Idiopathic Normal Pressure Hydrocephalus (ENDOVEST): A Randomized Trial
Run by University Hospital, Basel, Switzerland · NCT06488248 · Data updated 2026-11-12
This study is testing whether a new surgical option called endoscopic third ventriculostomy can help older adults with idiopathic normal pressure hydrocephalus feel better, just like the traditional ventriculoperitoneal shunt, but with fewer risks.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 40 Years and up |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Locations | 1 site (Basel) |
| Status | Recruiting |
| Started | January 17, 2025 |
| Main results expected | July 1, 2028 |
| Study ends | July 1, 2028 |
| Registry record updated | February 3, 2025 |
| Trial ID | NCT06488248 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are individuals over 40 years old with symptoms of iNPH lasting between 3 to 24 months, including gait disturbances and cognitive impairment.
✕Probably not a fit
Patients with secondary causes of hydrocephalus, significant neurological conditions, or those unable to provide informed consent may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to compare the effectiveness of two surgical interventions, endoscopic third ventriculostomy (ETV) and ventriculoperitoneal shunt (VPS), in treating idiopathic normal pressure hydrocephalus (iNPH). The study is a single-center, two-arm, open-labeled, randomized controlled trial that focuses on clinical improvement in patients suffering from iNPH. It targets elderly individuals who experience symptoms such as gait disturbances, cognitive decline, and urinary dysfunction. The goal is to determine whether ETV can provide similar symptom relief as VPS while reducing the risk of complications associated with shunt placement.
Why it matters
Potential benefit: If successful, this study could provide a safer surgical option for patients with idiopathic normal pressure hydrocephalus, potentially leading to fewer complications and improved quality of life.
How similar studies have gone: Previous studies have shown that ETV can be effective for certain types of hydrocephalus, but this specific comparison with VPS in iNPH is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Department of Neurosurgery, University Hospital of Basel
Basel, Switzerland Recruiting
Study contacts
- Principal investigator: Florian Marc Ebel, Dr. med. — Department of Neurosurgery, University Hospital of Basel
- Study coordinator: Florian Marc Ebel, Dr. med.
- Email: florianmarc.ebel@usb.ch
- Phone: +41 61 32 84296
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.