AzTrials
AzTrials

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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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
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.

Florian Marc Ebel, Dr. med. contact

+41 61 32 84296

florianmarc.ebel@usb.ch

Raphael Guzman, Prof. Dr. med. contact

+41 61 32 87522

raphael.guzman@usb.ch

Switzerland1 site, 1 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.

    Recruiting

Other trials in Switzerland

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 groups in NCT06488248
Study groupRoleWhat they receive
Endoscopic third ventriculostomy (ETV) groupExperimentalThe 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) groupOtherThe 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. Ventricular volumetry

    In a radiological assessment the ventricular volumetry is measured.

    Measured: Up to 5 days, 2, 6, and 12 months after surgery

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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.

  1. First posted5 Jul 2024
  2. Study start17 Jan 2025
  3. Primary completion1 Jul 2028 (estimated)
  4. Study completion1 Jul 2028 (estimated)

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in