Combining tests and scans to improve diagnosis and surgery decisions in idiopathic normal pressure hydrocephalus
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
Run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · NCT07427836 · Data updated 2026-11-12
This project will try combining memory and gait tests, spinal fluid markers, and brain MRI to see if that helps identify people over 60 with suspected iNPH who are likely to benefit from shunt surgery.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 60 Years to 85 Years |
| Sex | All |
| Enrollment | 116 (estimated) |
| Sponsor | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico Academic / other |
| Locations | 2 sites (Milan and 1 other locations) |
| Status | Recruiting |
| Started | February 11, 2026 |
| Main results expected | July 2034 |
| Study ends | January 2035 |
| Registry record updated | February 23, 2026 |
| Trial ID | NCT07427836 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
People aged 60 or older with suspected iNPH who are referred to the center's standardized diagnostic pathway and can give informed consent are eligible.
✕Probably not a fit
Patients who have an alternative diagnosis (for example advanced Alzheimer's disease or other neurodegenerative/vascular conditions) or who are not surgical candidates are less likely to benefit from the findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an observational cohort at a tertiary referral center enrolling people aged 60+ referred for suspected idiopathic normal pressure hydrocephalus. Participants undergo routine clinical data collection including standardized neuropsychological testing, motor and gait assessments before and after a CSF tap test, cerebrospinal fluid biomarker analysis, and brain MRI. Patients who proceed to CSF shunt surgery are compared with those given an alternative diagnosis and managed without surgery to examine differences in clinical, biomarker, and imaging features. Secondary analyses relate multimodal changes to surgical outcomes, including clinical response around six months when available.
Why it matters
Potential benefit: If successful, the approach could help doctors pick the right patients for shunt surgery and reduce delayed or unnecessary procedures.
How similar studies have gone: Previous work has shown that CSF tap tests, gait and cognitive measures, MRI features, and some CSF biomarkers can partly predict shunt response, but integrated multimodal prediction has not been fully validated.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Refusal or inability to provide informed consent.
Where it's running
-
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy Recruiting -
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy Active not recruiting
Study contacts
- Study coordinator: Andrea Arighi, MD
- Email: andrea.arighi@policlinico.mi.it
- Phone: +39 0255033814
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.