Clinical trial NCT06488248: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Idiopathic Normal Pressure Hydrocephalus (INPH)
Keywords: Surgical treatment
Neurosurgery
Endoscopic third ventriculostomy (ETV)
Ventriculoperitoneal shunt (VPS)
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2024-07-05
Enrollment: 150
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: idiopathic normal pressure hydrocephalus (iNPH) score
timeFrame: Before surgery (baseline), up to 5 days, 2, 6, and 12 months after surgery
Secondary outcomes:
measure: Level of consciousness (Glasgow Coma Scale)
timeFrame: Before surgery (baseline), up to 5 days, 2, 6, and 12 months after surgery
measure: Degree of disability and dependency (modified Rankin Scale)
timeFrame: Up to 5 days, 2, 6, and 12 months after surgery
measure: Cognitive function (Montreal Cognitive Assessment)
timeFrame: Before surgery (baseline), up to 5 days, 2, 6, and 12 months after surgery
measure: GaitRite walkway
timeFrame: At 2 and 12 months after surgery
measure: Timed-Up-and-Go Test
timeFrame: At 2 and 12 months after surgery
measure: Modified Clinical Test of Sensory Interaction on Balance
timeFrame: At 2 and 12 months after surgery
measure: Modified Balance Error Scoring System
timeFrame: Before surgery (baseline), at 2 and 12 months after surgery
measure: 5-times-sit-to-stand test
timeFrame: At 2 and 12 months after surgery
measure: Hand grip strength test
timeFrame: At 2 and 12 months after surgery
measure: Montreal Cognitive Assessment
timeFrame: At 2 and 12 months after surgery
measure: Test of Attentional Performance
timeFrame: At 2 and 12 months after surgery
measure: Trail Making Test
timeFrame: At 2 and 12 months after surgery
measure: Stroop-Test
timeFrame: At 2 and 12 months after surgery
measure: CERAD Word List
timeFrame: At 2 and 12 months after surgery
measure: CERAD Constructive Praxis
timeFrame: At 2 and 12 months after surgery
measure: Boston Naming Test
timeFrame: At 2 and 12 months after surgery
measure: Rey-Osterrieth Complex Figure Test
timeFrame: At 2 and 12 months after surgery
measure: Intensity of depression (Beck Depression Inventory)
timeFrame: Before surgery (baseline), at 2 and 12 months after surgery
measure: Flow-void presence
timeFrame: Up to 5 days, 2, 6, and 12 months after surgery
measure: Ventricular volumetry
timeFrame: Up to 5 days, 2, 6, and 12 months after surgery
measure: Periventricular perfusion measurements
timeFrame: Up to 5 days, 2, 6, and 12 months after surgery
measure: iNPH Radiological Scale
timeFrame: Up to 5 days, 2, 6, and 12 months after surgery
measure: iNPH severity
timeFrame: Before surgery (baseline), up to 5 days, 2, 6, and 12 months after surgery
measure: Health-related quality of life
timeFrame: At 2, 6, and 12 months after surgery
measure: Evaluation of complications
timeFrame: Up to 5 days, 2, 6, and 12 months after surgery
measure: Evaluation of revision surgery
timeFrame: Up to 5 days, 2, 6, and 12 months after surgery
measure: Mortality
timeFrame: Up to 5 days, 2, 6, and 12 months after surgery
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Neurosurgery, University Hospital of Basel
Study officials:
affiliation: Department of Neurosurgery, University Hospital of Basel
name: Florian Marc Ebel, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: