Endoscopic Third Ventriculostomy vs. Ventriculoperitoneal Shunt in Idiopathic Normal Pressure Hydrocephalus (ENDOVEST)
NCT Number: NCT06488248
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Idiopathic Normal Pressure Hydrocephalus (INPH)
Interventions: PROCEDURE: Endoscopic third ventriculostomy (ETV)|PROCEDURE: Ventriculoperitoneal shunt (VPS)
Sponsor: University Hospital, Basel, Switzerland
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2028-07-01
Locations: Department of Neurosurgery, University Hospital of Basel, Basel, 4031, Switzerland

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.

Primary Outcome Measures: Clinical Improvement, The clinical improvement is assessed during the 12-month follow-up. It is defined as a 2-point improvement on the Japanese idiopathic normal pressure hydrocephalus (iNPH) score compared to the preoperative condition. The iNPH score encompasses the three cardinal symptoms in idiopathic normal pressure hydrocephalus, including gait disturbance, dementia, and urinary incontinence. It assigns 0 to 4 points per category based on severity, resulting in a 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, up to 5 days, 2, 6, and 12 months after surgery
Secondary Outcome Measures: Level of consciousness (Glasgow Coma Scale), The Glasgow Coma Scale (GCS) is used to assess the level of consciousness by evaluating eye, verbal, and motor responses. The GCS score ranges from 3 to 15, with higher scores indicating better neurological function and a less severe brain injury. A score of 3 represents deep unconsciousness, while a score of 15 indicates full alertness and orientation., Up to 5 days, 2, 6, and 12 months after surgery|Degree of disability and dependency (modified Rankin Scale), The modified Rankin Scale (mRS) is used to assess the degree of disability and dependency in everyday life. Th mRS is a standard tool to assess the neurological outcome in trials with acute severe brain disease. The mRS ranges from 0 (no disability) to 6 (death). Lower values indicate less disability., Up to 5 days, 2, 6, and 12 months after surgery|Cognitive function (Montreal Cognitive Assessment), The Montreal Cognitive Assessment (MoCA) is used to evaluate cognitive function and detect mild cognitive impairment. It scores between 0 and 30, with higher scores indicating better cognitive performance. A score of 26 or above is generally considered normal., Up to 5 days, 2, 6, and 12 months after surgery|GaitRite walkway, To assess the gait and balance, a 10-metre GaitRite walkway, specifically designed to measure and analyze gait patterns, is performed. The body's movement are recorded using the the Ambulatory Parkinson's Disease Monitoring (APDM) Mobility Lab System., At 2 and 12 months after surgery|Timed-Up-and-Go Test, To assess the gait and balance, the Timed-Up-and-Go Test is performed. This is a simple and quick assessment to measure the time taken for an individual to stand up from a chair, walk three meters, turn around, walk back to the chair, and sit down again, with shorter times indicating better mobility., At 2 and 12 months after surgery|Modified Clinical Test of Sensory Interaction on Balance, To assess the gait and balance, the modified Clinical Test of Sensory Interaction on Balance (mCTSIB, 30 seconds) is performed. The mCTSIB measures a person's ability to maintain stability in different sensory conditions for 30 seconds each., At 2 and 12 months after surgery|Modified Balance Error Scoring System, To assess the gait and balance, the modified Balance Error Scoring System (mBESS) is performed. The mBESS involves performing three standing balance tasks (double-leg stance, single-leg stance, and tandem stance) on both firm and foam surfaces, with errors recorded to gauge balance performance., At 2 and 12 months after surgery|5-times-sit-to-stand test, To assess the gait and balance, the 5-times-sit-to-stand test is performed. It involves timing how long it takes a person to rise from a seated position to a standing position five times as quickly as possible., At 2 and 12 months after surgery|Hand grip strength test, To assess the gait and balance, the hand grip strength test is performed. It assesses the maximum isometric strength of the hand and forearm muscles and involves using a dynamometer to measure the force exerted when a person squeezes the device with their hand., At 2 and 12 months after surgery|Montreal Cognitive Assessment, As a neuropsychological assessment the Montreal Cognitive Assessment is performed to evaluate cognitive function and detect mild cognitive impairment. It assesses various cognitive domains, including memory, attention, language, and executive functions, with a maximum score of 30 points; higher scores indicate better cognitive function., At 2 and 12 months after surgery|Test of Attentional Performance, As a neuropsychological assessment the TAP Test (Test of Attentional Performance) is a computer-based assessment used to evaluate different aspects of attention, such as alertness, divided attention, and sustained attention. It measures reaction times and accuracy across various tasks designed to assess cognitive functions related to attentional control and processing speed., At 2 and 12 months after surgery|Trail Making Test, As a neuropsychological assessment the Trail Making Test is performed to evaluate cognitive flexibility, visual attention, and task-switching abilities. It consists of two parts: Part A involves connecting numbered circles sequentially, while Part B requires alternating between numbers and letters in ascending order. The test measures executive functioning and processing speed, with longer completion times indicating potential cognitive impairment., At 2 and 12 months after surgery|Stroop-Test, As a neuropsychological assessment the Stroop-Test is performed to measure selective attention, cognitive flexibility, and processing speed. It typically involves presenting color names (e.g., "red," "blue") printed in incongruent colored ink (e.g., the word "red" printed in blue ink), and participants are required to name the ink color while ignoring the word. The test assesses the ability to inhibit automatic responses and is sensitive to cognitive impairments, with longer response times or increased errors indicating potential difficulties in executive functioning., At 2 and 12 months after surgery|CERAD Word List, The Consortium to Establish a Registry for Alzheimer's Disease (CERAD) Word List is used as a neuropsychological assessment to evaluate verbal memory. It consists of a list of 10 common words that the participant is asked to recall immediately after hearing them. This test assesses the ability to remember and retrieve information shortly after it was presented, providing insights into memory function and potential cognitive impairments., At 2 and 12 months after surgery|CERAD Constructive Praxis, The CERAD Constructive Praxis is used as a neuropsychological assessment to assess visuospatial and constructional abilities by asking participants to copy a series of geometric figures. This test helps evaluate visual perception, spatial orientation, and motor skills, providing insights into cognitive functioning., At 2 and 12 months after surgery|Boston Naming Test, As a neuropsychological assessment the Boston Naming Test is performed. It assesses the ability to name objects or pictures presented by the examiner, evaluating language and semantic memory functions., At 2 and 12 months after surgery|Rey-Osterrieth Complex Figure Test, As a neuropsychological assessment the Rey-Osterrieth Complex Figure Test is performed. It assesses visuospatial and constructional abilities as well as visual memory. It involves copying a complex figure and then recalling and reproducing it from memory., At 2 and 12 months after surgery|Intensity of depression (Beck Depression Inventory), The Beck Depression Inventory (BDI) is used to assess the intensity of depression. The BDI is a self-report questionnaire designed to assess the severity of depressive symptoms. It consists of 21 multiple-choice questions, each related to a specific symptom of depression such as sadness, pessimism, guilt, and fatigue. Scores on the BDI can range from 0 to 63, with higher scores indicating more severe depressive symptoms., At 2 and 12 months after surgery|Flow-void presence, In a radiological assessment the flow-void presence is determined., Up to 5 days, 2, 6, and 12 months after surgery|Ventricular volumetry, In a radiological assessment the ventricular volumetry is measured., Up to 5 days, 2, 6, and 12 months after surgery|Periventricular perfusion measurements, In a radiological assessment periventricular perfusion measurements are carried out., Up to 5 days, 2, 6, and 12 months after surgery|iNPH Radiological Scale, In a radiological assessment the idiopathic normal pressure hydrocephalus (iNPH) radiological scale is assessed. Scores typically range from 0 to 12, with higher scores indicating greater severity of radiological findings suggestive of iNPH, such as enlarged ventricles, narrow sulci, and periventricular white matter changes., Up to 5 days, 2, 6, and 12 months after surgery|Health-related quality of life, The quality of life is assessed using the 15D health-related quality of life (HRQoL) patient-reported questionnaire. It cover aspects like physical functioning, emotional well-being, social functioning, and pain. Scores can range from 0 to 100, with higher scores reflecting better perceived health and functioning across various domains, while lower scores suggest greater impairment and reduced quality of life., At 2, 6, and 12 months after surgery|Evaluation of complications, During hospitalization, 6-8 weeks, as well as 6- and 12-month follow-up, the incidence of complications is assessed. Complications are defined as infections, bleeding, shunt dysfunction (e.g., due to misplacement, obstruction of the proximal ventricular catheter, dysfunction of the valve, dysfunction of the peritoneal catheter), ETV occlusions (requiring re-ETV or VPS insertion), and neuronal tissue injury (e.g., fornix injury)., Up to 5 days, 2, 6, and 12 months after surgery|Evaluation of revision surgery, during hospitalization, 6-8 weeks, as well as 6- and 12-month follow-up, the incidence and reason of revision surgery is assessed., Up to 5 days, 2, 6, and 12 months after surgery|Mortality, The mortality is assessed during hospitalization and the 12-month follow-up, Up to 5 days, 2, 6, and 12 months after surgery