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

Official title

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

Overview

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.

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 is characterized by fluid buildup in the brain with normal cerebrospinal fluid pressure and is unique among neurodegenerative disorders in its potential for successful treatment. Common symptoms include difficulty walking, urinary incontinence, and cognitive decline, which significantly impact quality of life.

The standard treatment involves inserting a ventriculoperitoneal shunt (VPS) to drain cerebrospinal fluid, achieving a 75% success rate in improving symptoms. However, VPS has a drawback: a high rate of revision surgery (approximately 18% during follow-up). An alternative treatment is endoscopic third ventriculostomy (ETV), which avoids placing foreign materials and thus eliminates risks associated with shunt malfunction and infections. ETV is an established neuroendoscopic procedure mainly used to treat non-communicating hydrocephalus, typically due to aqueduct stenosis.

This study aims to compare ETV and VPS for the treatment of iNPH to investigate whether ETV leads to fewer complications while achieving a comparable rate of postoperative symptom improvement.

Interventions

• Procedure Endoscopic third ventriculostomy (ETV)
  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.
• Procedure Ventriculoperitoneal shunt (VPS)
  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 lev

Primary outcome measures

• idiopathic normal pressure hydrocephalus (iNPH) score [Time frame: Before surgery (baseline), up to 5 days, 2, 6, and 12 months after surgery]

Secondary outcome measures (12)

• Level of consciousness (Glasgow Coma Scale) [Time frame: Before surgery (baseline), up to 5 days, 2, 6, and 12 months after surgery]
• Degree of disability and dependency (modified Rankin Scale) [Time frame: Up to 5 days, 2, 6, and 12 months after surgery]
• Cognitive function (Montreal Cognitive Assessment) [Time frame: Before surgery (baseline), up to 5 days, 2, 6, and 12 months after surgery]
• GaitRite walkway [Time frame: At 2 and 12 months after surgery]
• Timed-Up-and-Go Test [Time frame: At 2 and 12 months after surgery]
• Modified Clinical Test of Sensory Interaction on Balance [Time frame: At 2 and 12 months after surgery]
• Modified Balance Error Scoring System [Time frame: Before surgery (baseline), at 2 and 12 months after surgery]
• 5-times-sit-to-stand test [Time frame: At 2 and 12 months after surgery]
• Hand grip strength test [Time frame: At 2 and 12 months after surgery]
• Montreal Cognitive Assessment [Time frame: At 2 and 12 months after surgery]
• Test of Attentional Performance [Time frame: At 2 and 12 months after surgery]
• Trail Making Test [Time frame: At 2 and 12 months after surgery]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Switzerland · 1 center

• Department of Neurosurgery, University Hospital of Basel — Basel

Identifiers

NCT: NCT06488248 · 2024-00845; ko23Soleman

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗