Endoscopic Third Ventriculostomy vs. Ventriculoperitoneal Shunt in Idiopathic Normal Pressure Hydrocephalus (ENDOVEST)

NCT06488248 | Recruiting

• 1 other identifier: 2024-00845; ko23Soleman
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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 treating idiopathic normal pressure hydrocephalus in terms of clinical improvement.

Conditions

Idiopathic Normal Pressure Hydrocephalus (INPH)

Keywords

Surgical treatment; Neurosurgery; Endoscopic third ventriculostomy (ETV); Ventriculoperitoneal shunt (VPS)

Outcome Measures

Primary Outcomes (1)

• idiopathic normal pressure hydrocephalus (iNPH) score

  The idiopathic normal pressure hydrocephalus (iNPH) score is used to measure the clinical improvement and complication rate. The iNPH score evaluates the three cardinal symptoms of iNPH-gait disturbance, dementia, and urinary incontinence-with each category assigned a score between 0 and 4 based on severity, resulting in a total score ranging from 0 (indicating normal) to 12 (reflecting the maximum severity of symptoms The score will be assessed during the outpatient consultation before surgery, at admission directly preceding surgery, and postoperatively at discharge, as well as during follow-up at 6-8 weeks, 6 months, and 12 months after the operation.

  Before surgery (baseline), up to 5 days, 2, 6, and 12 months after surgery

Secondary Outcomes (27)

• Level of consciousness (Glasgow Coma Scale)

  Before surgery (baseline), up to 5 days, 2, 6, and 12 months after surgery

• Degree of disability and dependency (modified Rankin Scale)

  Up to 5 days, 2, 6, and 12 months after surgery

• Cognitive function (Montreal Cognitive Assessment)

  Before surgery (baseline), up to 5 days, 2, 6, and 12 months after surgery

• GaitRite walkway

  At 2 and 12 months after surgery

• Timed-Up-and-Go Test

  At 2 and 12 months after surgery

Study Arms (2)

Endoscopic third ventriculostomy (ETV) group

EXPERIMENTAL

The investigational group undergoes endoscopic third ventriculostomy (ETV) for the treatment of idiopathic normal pressure hydrocephalus (iNPH).

Procedure: Endoscopic third ventriculostomy (ETV)

Ventriculoperitoneal shunt (VPS) group

OTHER

The control group undergoes ventriculoperitoneal shunt (VPS) implantation for the treatment of iNPH.

Procedure: Ventriculoperitoneal shunt (VPS)

Interventions

Endoscopic third ventriculostomy (ETV) PROCEDURE

The procedure is performed using an endoscope (LOTTA® system, Karl Storz Endoscopes, Germany; Minop®, BBraun, Tuttlingen, Germany or equivalent). The intervention is carried out under general anesthesia, with the procedure typically lasting around 60 minutes.

Endoscopic third ventriculostomy (ETV) group

Ventriculoperitoneal shunt (VPS) PROCEDURE

The procedure entails the insertion of a catheter into both the ventricular system and the peritoneal cavity, connected to a programmable valve that regulates cerebrospinal fluid flow. The choice of programmable valve (Codman Hakim or Codman Certas Programmable Valves, Integra, Plainsboro, USA; Strata valve, Medtronic, Minneapolis, USA; Sophysa, Orsay, France; Miethke proGAV, Aesculap, Tuttlingen, Germany) is at the surgeon's discretion. The preoperative valve setting is preset to a pressure level between 85 - 135 mmH2O. The VPS procedure is conducted under general anesthesia and typically lasts approximately 90-120 minutes.

Ventriculoperitoneal shunt (VPS) group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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

You may not qualify if:

• ≤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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Department of Neurosurgery, University Hospital of Basel

Basel, 4031, Switzerland

RECRUITING

MeSH Terms

Interventions

Ventriculostomy; Ventriculoperitoneal Shunt

Intervention Hierarchy (Ancestors)

Cerebrospinal Fluid Shunts; Anastomosis, Surgical; Surgical Procedures, Operative; Neurosurgical Procedures

Study Officials

• Florian Marc Ebel, Dr. med.

  Department of Neurosurgery, University Hospital of Basel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Florian Marc Ebel, Dr. med.

CONTACT

+41 61 32 84296; florianmarc.ebel@usb.ch

Raphael Guzman, Prof. Dr. med.

CONTACT

+41 61 32 87522; raphael.guzman@usb.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: July 5, 2024
• Study Start: January 17, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: February 3, 2025

Record last verified: 2025-01

Locations

CH (1)