Endoscopic Third Ventriculostomy Compared to Ventriculoperitoneal Shunt as Treatment for Idiopathic Normal Pressure Hydrocephalus (ENDOVEST): A Randomized Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• \>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

Locations
Other Locations
Switzerland
Department of Neurosurgery, University Hospital of Basel
RECRUITING
Basel
Contact Information
Primary
Florian Marc Ebel, Dr. med.
florianmarc.ebel@usb.ch
+41 61 32 84296
Backup
Raphael Guzman, Prof. Dr. med.
raphael.guzman@usb.ch
+41 61 32 87522
Time Frame
Start Date: 2025-01-17
Estimated Completion Date: 2028-07-01
Participants
Target number of participants: 150
Treatments
Experimental: Endoscopic third ventriculostomy (ETV) group
The investigational group undergoes endoscopic third ventriculostomy (ETV) for the treatment of idiopathic normal pressure hydrocephalus (iNPH).
Other: Ventriculoperitoneal shunt (VPS) group
The control group undergoes ventriculoperitoneal shunt (VPS) implantation for the treatment of iNPH.
Sponsors
Leads: University Hospital, Basel, Switzerland

This content was sourced from clinicaltrials.gov