Idiopathic Normal Pressure Hydrocephalus (INPH)NCT06488248
Endoscopic Third Ventriculostomy vs. Ventriculoperitoneal Shunt in Idiopathic Normal Pressure Hydrocephalus (ENDOVEST)
A study testing Endoscopic third ventriculostomy (ETV) and Ventriculoperitoneal shunt (VPS) in people with Idiopathic Normal Pressure Hydrocephalus (INPH), run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Idiopathic Normal Pressure Hydrocephalus (INPH)
- What is being tested?
- Endoscopic third ventriculostomy (ETV) and Ventriculoperitoneal shunt (VPS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSwitzerland
- Study dates
- 17 Jan 2025to 1 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >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
Who cannot join
- ≤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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Department of Neurosurgery, University Hospital of Basel
Basel, 4031
Florian Marc Ebel, Dr. med., +41 61 32 84296, florianmarc.ebel@usb.ch
Florian Marc Ebel, Dr. med.
About this study
Official title: Endoscopic Third Ventriculostomy Compared to Ventriculoperitoneal Shunt as Treatment for Idiopathic Normal Pressure Hydrocephalus (ENDOVEST): A Randomized Trial
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.
Read the 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.
- Being tested
- Endoscopic third ventriculostomy (ETV), Ventriculoperitoneal shunt (VPS)
- Keywords
- Surgical treatment, Neurosurgery, Endoscopic third ventriculostomy (ETV), Ventriculoperitoneal shunt (VPS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic third ventriculostomy (ETV)Procedure or surgery
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.
Ventriculoperitoneal shunt (VPS)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic third ventriculostomy (ETV) group | Experimental | The investigational group undergoes endoscopic third ventriculostomy (ETV) for the treatment of idiopathic normal pressure hydrocephalus (iNPH). Receives: Procedure: Endoscopic third ventriculostomy (ETV) |
| Ventriculoperitoneal shunt (VPS) group | Other | The control group undergoes ventriculoperitoneal shunt (VPS) implantation for the treatment of iNPH. Receives: Procedure: Ventriculoperitoneal shunt (VPS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before surgery (baseline), up to 5 days, 2, 6, and 12 months after surgery
Secondary outcomes (27)
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.
Measured: Before surgery (baseline), 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.
Measured: 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.
Measured: Before surgery (baseline), 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Before surgery (baseline), 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Before surgery (baseline), at 2 and 12 months after surgery
Flow-void presence
In a radiological assessment the flow-void presence is determined.
Measured: Up to 5 days, 2, 6, and 12 months after surgery
Ventricular volumetry
In a radiological assessment the ventricular volumetry is measured.
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.
Measured: 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.
Measured: Up to 5 days, 2, 6, and 12 months after surgery
iNPH severity
iNPH severity is measured using the Hellström score, which ranges from 0 to 12, with higher scores indicating more severe symptoms across domains of gait, balance, and cognitive impairment.
Measured: Before surgery (baseline), 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.
Measured: 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).
Measured: 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.
Measured: Up to 5 days, 2, 6, and 12 months after surgery
Mortality
The mortality is assessed during hospitalization and the 12-month follow-up
Measured: Up to 5 days, 2, 6, and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start17 Jan 2025
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Normal Pressure Hydrocephalus (INPH)Studies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florian Marc Ebel, Dr. med., Principal investigator, Department of Neurosurgery, University Hospital of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06488248
- Sponsor's protocol ID
- 2024-00845; ko23Soleman
- Status last verified
- Jan 2025
- First submitted
- 18 Jun 2024
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Third Ventriculostomy Compared to Ventriculoperitoneal Shunt as Treatment for Idiopathic Normal Pressure Hydrocephalus (ENDOVEST): A Randomized Trial
- ClinicalTrials.gov ID
- NCT06488248
- Acronym / sponsor ID
- 2024-00845; ko23Soleman
- Keywords
- Surgical treatment, Neurosurgery, Endoscopic third ventriculostomy (ETV), Ventriculoperitoneal shunt (VPS)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 17 Jan 2025 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 5 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic third ventriculostomy (ETV) group | Experimental | Procedure: Endoscopic third ventriculostomy (ETV)The investigational group undergoes endoscopic third ventriculostomy (ETV) for the treatment of idiopathic normal pressure hydrocephalus (iNPH). |
| Ventriculoperitoneal shunt (VPS) group | Other | Procedure: Ventriculoperitoneal shunt (VPS)The control group undergoes ventriculoperitoneal shunt (VPS) implantation for the treatment of iNPH. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- >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
Key exclusion criteria (7 listed)
- ≤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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 or surgery | Endoscopic third ventriculostomy (ETV) group |
| 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 level between 85 - 135 mmH2O. The VPS procedure is conducted under general anesthesia and typically lasts approximately 90-120 minutes. | Procedure or surgery | Ventriculoperitoneal shunt (VPS) group |
Primary outcome
idiopathic normal pressure hydrocephalus (iNPH) score
Time frame: 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.
27 secondary outcomes
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
Stroop-Test
Time frame: At 2 and 12 months after surgery
CERAD Word List
Time frame: At 2 and 12 months after surgery
CERAD Constructive Praxis
Time frame: At 2 and 12 months after surgery
Boston Naming Test
Time frame: At 2 and 12 months after surgery
Rey-Osterrieth Complex Figure Test
Time frame: At 2 and 12 months after surgery
Intensity of depression (Beck Depression Inventory)
Time frame: Before surgery (baseline), at 2 and 12 months after surgery
Flow-void presence
Time frame: Up to 5 days, 2, 6, and 12 months after surgery
Ventricular volumetry
Time frame: Up to 5 days, 2, 6, and 12 months after surgery
Periventricular perfusion measurements
Time frame: Up to 5 days, 2, 6, and 12 months after surgery
iNPH Radiological Scale
Time frame: Up to 5 days, 2, 6, and 12 months after surgery
iNPH severity
Time frame: Before surgery (baseline), up to 5 days, 2, 6, and 12 months after surgery
Health-related quality of life
Time frame: At 2, 6, and 12 months after surgery
Evaluation of complications
Time frame: Up to 5 days, 2, 6, and 12 months after surgery
Evaluation of revision surgery
Time frame: Up to 5 days, 2, 6, and 12 months after surgery
Mortality
Time frame: Up to 5 days, 2, 6, and 12 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Florian Marc Ebel, Dr. med. principal investigator
Department of Neurosurgery, University Hospital of Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic third ventriculostomy (ETV) and Ventriculoperitoneal shunt (VPS) in people with Idiopathic Normal Pressure Hydrocephalus (INPH), run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Florian Marc Ebel, Dr. med. (+41 61 32 84296, florianmarc.ebel@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
idiopathic normal pressure hydrocephalus (iNPH) score (time frame: Before surgery (baseline), up to 5 days, 2, 6, and 12 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.