Status:
RECRUITING
Endoscopic Third Ventriculostomy vs. Ventriculoperitoneal Shunt in Idiopathic Normal Pressure Hydrocephalus (ENDOVEST)
Lead Sponsor:
University Hospital, Basel, Switzerland
Conditions:
Idiopathic Normal Pressure Hydrocephalus (INPH)
Eligibility:
All Genders
40+ years
Phase:
NA
Brief 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...
Detailed Description
Idiopathic normal pressure hydrocephalus (iNPH) primarily affects elderly individuals, with prevalence rates of approximately 1.4% among those over 65 years and 5.9% among those over 80 years old. It ...
Eligibility Criteria
Inclusion
- \>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
- ≤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
Key Trial Info
Start Date :
January 17 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2028
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06488248
Start Date
January 17 2025
End Date
July 1 2028
Last Update
February 3 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Neurosurgery, University Hospital of Basel
Basel, Switzerland, 4031