Idiopathic Normal Pressure HydrocephalusNPH-OPTIMIZENCT07427836
Integrated Multimodal Assessment to Optimize Diagnosis and Surgical Selection in Idiopathic Normal Pressure Hydrocephalus
An observational study of Idiopathic Normal Pressure Hydrocephalus, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 2 sites in Italy.
Trial summary
Idiopathic normal pressure hydrocephalus (iNPH) is a neurological condition that can cause walking difficulties, cognitive impairment, and urinary incontinence. Although iNPH can be treated with cerebrospinal fluid (CSF) shunt surgery, diagnosis is often challenging because its symptoms and brain imaging findings may… Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Idiopathic Normal Pressure Hydrocephalus
- How many people
- 116 participants
- Where
- 2 sitesItaly
- Study dates
- 11 Feb 2026to Jan 2035
- Phase
- Observational
- 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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population includes adults aged 60 years or older with suspected idiopathic normal pressure hydrocephalus who are referred to a standardized diagnostic, therapeutic, and care pathway at a tertiary referral center. Participants undergo clinical, cognitive, motor, cerebrospinal fluid, and neuroimaging evaluations as part of routine clinical practice.
Who may be able to join
- Age 60 years or older.
- Patients with suspected idiopathic normal pressure hydrocephalus referred to the institutional diagnostic, therapeutic, and care pathway.
- Ability to provide written informed consent.
Who cannot join
- Refusal or inability to provide informed consent.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 1 recruiting
- Recruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, 20122
Milena Scauso, +39-02-5503-6197, milena.scauso@policlinico.mi.it
- Active, not recruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, 20122
About this study
Official title: Integrated Multimodal Approach for Diagnostic Optimization and Surgical Candidate Selection in Idiopathic Normal Pressure Hydrocephalus: The Role of CSF Biomarkers, Cognitive-Motor Assessment, and Neuroimaging
Idiopathic normal pressure hydrocephalus (iNPH) is a neurological condition that can cause walking difficulties, cognitive impairment, and urinary incontinence. Although iNPH can be treated with cerebrospinal fluid (CSF) shunt surgery, diagnosis is often challenging because its symptoms and brain imaging findings may overlap with those of other neurodegenerative disorders, such as Alzheimer's disease or vascular parkinsonism. As a result, some patients may experience delayed diagnosis or may not be referred for potentially beneficial surgical treatment.
This observational study aims to evaluate whether combining different types of clinical information can improve the diagnosis of iNPH and help identify patients who are more likely to benefit from surgery. The study integrates cognitive testing, motor performance assessment, CSF biomarker analysis, and brain magnetic resonance imaging.
Read more
Patients aged over 60 years with suspected iNPH who are evaluated within a standardized diagnostic care pathway will be included. Cognitive and motor performance will be assessed before and after a cerebrospinal fluid tap test, which is part of routine clinical practice. Results will be compared between patients who receive a confirmed diagnosis of iNPH and undergo CSF shunt surgery and patients who receive an alternative diagnosis and do not undergo surgical treatment.
The results of this study may help improve diagnostic accuracy, reduce false-negative test results, and support better clinical decision-making in patients with suspected idiopathic normal pressure hydrocephalus.
Read the detailed description
This is an observational, non-interventional cohort study designed to assess the diagnostic and prognostic value of a multimodal approach in patients with suspected idiopathic normal pressure hydrocephalus (iNPH).
The study includes patients aged over 60 years who are referred to a standardized diagnostic, therapeutic, and care pathway for suspected iNPH at a tertiary referral center. All data are collected as part of routine clinical practice after informed consent.
Clinical data collection includes demographic and medical information, standardized neuropsychological assessments, motor performance tests, cerebrospinal fluid (CSF) analysis, and brain magnetic resonance imaging. Cognitive and motor assessments are performed before and after the CSF tap test, which is routinely used to support diagnostic and therapeutic decision-making in iNPH.
The exposed cohort consists of patients with confirmed iNPH who undergo CSF shunt surgery, while the non-exposed cohort includes patients who receive an alternative diagnosis and are managed without surgical intervention. The two groups will be compared with respect to changes in cognitive and motor performance, CSF biomarker profiles, and neuroimaging parameters.
Secondary analyses will explore associations between changes in cognitive and motor outcomes, CSF biomarkers, neuroimaging features, and surgical outcomes, including clinical response at 6 months following surgery when available within the study timeframe.
The study combines prospectively collected data with retrospectively available clinical data to provide a comprehensive characterization of patients with suspected iNPH and to support improved diagnostic accuracy and surgical candidate selection.
- Conditions
- Idiopathic Normal Pressure Hydrocephalus
- Keywords
- Cognition, CSF biomarkers, CSF tap test, Gait assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Idiopathic Normal Pressure Hydrocephalus - Surgical Cohort | Patients with confirmed idiopathic normal pressure hydrocephalus who undergo cerebrospinal fluid shunt surgery as part of standard clinical care. All diagnostic procedures, surgical decisions, and follow-up assessments are performed according to routine clinical practice. No experimental interventions are assigned within this observational study. | |
| Non-Surgical Comparison Cohort | Patients evaluated for suspected idiopathic normal pressure hydrocephalus who receive an alternative diagnosis and do not undergo cerebrospinal fluid shunt surgery. All diagnostic procedures, surgical decisions, and follow-up assessments are performed according to routine clinical practice. No experimental interventions are assigned within this observational study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Montreal Cognitive Assessment (MoCA) total score after CSF tap test
Difference in MoCA total score between baseline (pre-CSF tap test) and 72 hours after CSF tap test in patients with suspected iNPH. Higher scores indicate better cognitive performance (range 0-30).
Measured: Baseline and 72 hours post-CSF tap test
Secondary outcomes (7)
Change in Simple Visual Reaction Time After CSF Tap Test
Difference in mean reaction time (milliseconds) between baseline and 72 hours after CSF tap test. Lower values indicate better performance.
Measured: Baseline and 72 hours post-CSF tap test
Change in Go/No-Go Test Accuracy After CSF Tap Test
Difference in response accuracy (%) between baseline and 72 hours after CSF tap test. Higher percentages indicate better inhibitory control and executive function.
Measured: Baseline and 72 hours post-CSF tap test
Change in Timed Up and Go (TUG) Test Score After CSF Tap Test
Difference in time required to complete the Timed Up and Go test (seconds) between baseline and 72 hours after CSF tap test. Lower times indicate better mobility performance.
Measured: Baseline and 72 hours post-CSF tap test
Change in Short Physical Performance Battery (SPPB) Score After CSF Tap Test
Difference in SPPB total score (range 0-12) between baseline and 72 hours after CSF tap test. Higher scores indicate better lower-extremity function.
Measured: Baseline and 72 hours post-CSF tap test
Change in Tinetti Performance-Oriented Mobility Assessment Score After CSF Tap Test
Difference in total Tinetti score (range 0-28) between baseline and 72 hours after CSF tap test. Higher scores indicate better gait and balance performance.
Measured: Difference in total Tinetti score (range 0-28) between baseline and 72 hours after CSF tap test. Higher scores indicate better gait and balance performance.
Cerebrospinal Fluid Biomarker Profile Differences Between Surgical and Non-Surgical Patients
Comparison of CSF biomarker concentrations measured at diagnostic lumbar puncture, including Aβ42, Aβ40, total tau, phosphorylated tau, Aβ42/Aβ40 ratio, p-tau/Aβ42 ratio, and aquaporin-4. Analyses will evaluate differences between patients undergoing CSF shunt surgery and those receiving an alternative diagnosis without surgery.
Measured: Baseline (at diagnostic lumbar puncture)
Association Between Multimodal Markers and Six-Month Surgical Outcome
Correlation between pre- to post-tap-test changes in cognitive and motor measures, CSF biomarkers, neuroimaging parameters, and clinical response at 6 months following CSF shunt surgery.
Measured: Baseline through 6 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start11 Feb 2026 (estimated)
- Primary completionJul 2034 (estimated)
- Study completionJan 2035 (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 HydrocephalusStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07427836
- Sponsor's protocol ID
- 0048426-U
- Acronym
- NPH-OPTIMIZE
- Status last verified
- Feb 2026
- First submitted
- 3 Feb 2026
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the study dataset contains sensitive personal health information and, despite de-identification, there remains a risk of re-identification. Data sharing is therefore limited to aggregated results to protect participant privacy and comply with applicable data protection regulations.
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Multimodal Approach for Diagnostic Optimization and Surgical Candidate Selection in Idiopathic Normal Pressure Hydrocephalus: The Role of CSF Biomarkers, Cognitive-Motor Assessment, and Neuroimaging
- ClinicalTrials.gov ID
- NCT07427836
- Acronym / sponsor ID
- NPH-OPTIMIZE / 0048426-U
- Conditions
- Idiopathic Normal Pressure Hydrocephalus
- Keywords
- Cognition, CSF biomarkers, CSF tap test, Gait assessment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 11 Feb 2026 (estimated)
- Primary completion
- Jul 2034 (estimated)
- Study completion
- Jan 2035 (estimated)
- First posted
- 23 Feb 2026 (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.
Idiopathic normal pressure hydrocephalus (iNPH) is a neurological condition that can cause walking difficulties, cognitive impairment, and urinary incontinence. Although iNPH can be treated with cerebrospinal fluid (CSF) shunt surgery, diagnosis is often challenging because its symptoms and brain imaging findings may overlap with those of other neurodegenerative disorders, such as Alzheimer's disease or vascular parkinsonism. As a result, some patients may experience delayed diagnosis or may not be referred for potentially beneficial surgical treatment.
This observational study aims to evaluate whether combining different types of clinical information can improve the diagnosis of iNPH and help identify patients who are more likely to benefit from surgery. The study integrates cognitive testing, motor performance assessment, CSF biomarker analysis, and brain magnetic resonance imaging.
Patients aged over 60 years with suspected iNPH who are evaluated within a standardized diagnostic care pathway will be included. Cognitive and motor performance will be assessed before and after a cerebrospinal fluid tap test, which is part of routine clinical practice. Results will be compared between patients who receive a confirmed diagnosis of iNPH and undergo CSF shunt surgery and patients who receive an alternative diagnosis and do not undergo surgical treatment.
The results of this study may help improve diagnostic accuracy, reduce false-negative test results, and support better clinical decision-making in patients with suspected idiopathic normal pressure hydrocephalus.
Detailed description
This is an observational, non-interventional cohort study designed to assess the diagnostic and prognostic value of a multimodal approach in patients with suspected idiopathic normal pressure hydrocephalus (iNPH).
The study includes patients aged over 60 years who are referred to a standardized diagnostic, therapeutic, and care pathway for suspected iNPH at a tertiary referral center. All data are collected as part of routine clinical practice after informed consent.
Clinical data collection includes demographic and medical information, standardized neuropsychological assessments, motor performance tests, cerebrospinal fluid (CSF) analysis, and brain magnetic resonance imaging. Cognitive and motor assessments are performed before and after the CSF tap test, which is routinely used to support diagnostic and therapeutic decision-making in iNPH.
The exposed cohort consists of patients with confirmed iNPH who undergo CSF shunt surgery, while the non-exposed cohort includes patients who receive an alternative diagnosis and are managed without surgical intervention. The two groups will be compared with respect to changes in cognitive and motor performance, CSF biomarker profiles, and neuroimaging parameters.
Secondary analyses will explore associations between changes in cognitive and motor outcomes, CSF biomarkers, neuroimaging features, and surgical outcomes, including clinical response at 6 months following surgery when available within the study timeframe.
The study combines prospectively collected data with retrospectively available clinical data to provide a comprehensive characterization of patients with suspected iNPH and to support improved diagnostic accuracy and surgical candidate selection.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Idiopathic Normal Pressure Hydrocephalus - Surgical Cohort | – | –Patients with confirmed idiopathic normal pressure hydrocephalus who undergo cerebrospinal fluid shunt surgery as part of standard clinical care. All diagnostic procedures, surgical decisions, and follow-up assessments are performed according to routine clinical practice. No experimental interventions are assigned within this observational study. |
| Non-Surgical Comparison Cohort | – | –Patients evaluated for suspected idiopathic normal pressure hydrocephalus who receive an alternative diagnosis and do not undergo cerebrospinal fluid shunt surgery. All diagnostic procedures, surgical decisions, and follow-up assessments are performed according to routine clinical practice. No experimental interventions are assigned within this observational study. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes adults aged 60 years or older with suspected idiopathic normal pressure hydrocephalus who are referred to a standardized diagnostic, therapeutic, and care pathway at a tertiary referral center. Participants undergo clinical, cognitive, motor, cerebrospinal fluid, and neuroimaging evaluations as part of routine clinical practice.
Key inclusion criteria (3 listed)
- Age 60 years or older.
- Patients with suspected idiopathic normal pressure hydrocephalus referred to the institutional diagnostic, therapeutic, and care pathway.
- Ability to provide written informed consent.
Key exclusion criteria (1 listed)
- Refusal or inability to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Montreal Cognitive Assessment (MoCA) total score after CSF tap test
Time frame: Baseline and 72 hours post-CSF tap test
Difference in MoCA total score between baseline (pre-CSF tap test) and 72 hours after CSF tap test in patients with suspected iNPH. Higher scores indicate better cognitive performance (range 0-30).
7 secondary outcomes
Change in Simple Visual Reaction Time After CSF Tap Test
Time frame: Baseline and 72 hours post-CSF tap test
Change in Go/No-Go Test Accuracy After CSF Tap Test
Time frame: Baseline and 72 hours post-CSF tap test
Change in Timed Up and Go (TUG) Test Score After CSF Tap Test
Time frame: Baseline and 72 hours post-CSF tap test
Change in Short Physical Performance Battery (SPPB) Score After CSF Tap Test
Time frame: Baseline and 72 hours post-CSF tap test
Change in Tinetti Performance-Oriented Mobility Assessment Score After CSF Tap Test
Time frame: Difference in total Tinetti score (range 0-28) between baseline and 72 hours after CSF tap test. Higher scores indicate better gait and balance performance.
Cerebrospinal Fluid Biomarker Profile Differences Between Surgical and Non-Surgical Patients
Time frame: Baseline (at diagnostic lumbar puncture)
Association Between Multimodal Markers and Six-Month Surgical Outcome
Time frame: Baseline through 6 months post-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 23 Feb 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the study dataset contains sensitive personal health information and, despite de-identification, there remains a risk of re-identification. Data sharing is therefore limited to aggregated results to protect participant privacy and comply with applicable data protection regulations.
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Unsteady Gait in Older People May be a Common and Treatable Neurological Disease Associated With Increased Mortality
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Normal Pressure Hydrocephalus, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 2 sites in Italy.
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 3 inclusion and 1 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 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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 Andrea Arighi, MD (+39 0255033814, andrea.arighi@policlinico.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Montreal Cognitive Assessment (MoCA) total score after CSF tap test (time frame: Baseline and 72 hours post-CSF tap test). 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 23 Feb 2026.