Endoscopic Third Ventriculostomy vs. Ventriculoperitoneal Shunt in Idiopathic Normal Pressure Hydrocephalus (ENDOVEST)
NCT06488248, Not applicable, Recruiting, University Hospital, Basel, Switzerland
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Endoscopic Third Ventriculostomy vs. Ventriculoperitoneal Shunt in Idiopathic Normal Pressure Hydrocephalus (ENDOVEST) | ClinicalTrials.gov |
| NCT number | NCT06488248 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 150 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | University Hospital, Basel, Switzerland | ClinicalTrials.gov |
| Conditions | Idiopathic Normal Pressure Hydrocephalus (INPH) | ClinicalTrials.gov |
| Interventions | Endoscopic third ventriculostomy (ETV), Ventriculoperitoneal shunt (VPS) | ClinicalTrials.gov |
| First posted | 2024-07-05 | ClinicalTrials.gov |
| Last updated | 2025-02-03 | ClinicalTrials.gov |
Registered outcomes 28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | idiopathic normal pressure hydrocephalus (iNPH) score | Before surgery (baseline), up to 5 days, 2, 6, and 12 months after surgery | 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. | ClinicalTrials.gov |
| Secondary | Level of consciousness (Glasgow Coma Scale) | Before surgery (baseline), up to 5 days, 2, 6, and 12 months after surgery | 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. | ClinicalTrials.gov |
| Secondary | Degree of disability and dependency (modified Rankin Scale) | Up to 5 days, 2, 6, and 12 months after surgery | 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. | ClinicalTrials.gov |
| Secondary | Cognitive function (Montreal Cognitive Assessment) | Before surgery (baseline), up to 5 days, 2, 6, and 12 months after surgery | 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. | ClinicalTrials.gov |
| Secondary | GaitRite walkway | At 2 and 12 months after surgery | 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. | ClinicalTrials.gov |
| Secondary | Timed-Up-and-Go Test | At 2 and 12 months after surgery | 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. | ClinicalTrials.gov |
| Secondary | Modified Clinical Test of Sensory Interaction on Balance | At 2 and 12 months after surgery | 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. | ClinicalTrials.gov |
| Secondary | Modified Balance Error Scoring System | Before surgery (baseline), at 2 and 12 months after surgery | 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. | ClinicalTrials.gov |
| Secondary | 5-times-sit-to-stand test | At 2 and 12 months after surgery | 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. | ClinicalTrials.gov |
| Secondary | Hand grip strength test | At 2 and 12 months after surgery | 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. | ClinicalTrials.gov |
| Secondary | Montreal Cognitive Assessment | At 2 and 12 months after surgery | 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. | ClinicalTrials.gov |
| Secondary | Test of Attentional Performance | At 2 and 12 months after surgery | 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. | ClinicalTrials.gov |
| Secondary | Trail Making Test | At 2 and 12 months after surgery | 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. | ClinicalTrials.gov |
| Secondary | Stroop-Test | At 2 and 12 months after surgery | 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. | ClinicalTrials.gov |
| Secondary | CERAD Word List | At 2 and 12 months after surgery | 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. | ClinicalTrials.gov |
| Secondary | CERAD Constructive Praxis | At 2 and 12 months after surgery | 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. | ClinicalTrials.gov |
| Secondary | Boston Naming Test | At 2 and 12 months after surgery | 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. | ClinicalTrials.gov |
| Secondary | Rey-Osterrieth Complex Figure Test | At 2 and 12 months after surgery | 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. | ClinicalTrials.gov |
| Secondary | Intensity of depression (Beck Depression Inventory) | Before surgery (baseline), at 2 and 12 months after surgery | 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. | ClinicalTrials.gov |
| Secondary | Flow-void presence | Up to 5 days, 2, 6, and 12 months after surgery | In a radiological assessment the flow-void presence is determined. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 7
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Complex Figure Copy and Recall | Secondary outcome | ConductCognition |
| Picture Naming Test | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Task Switching Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Learning | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)