NCT07427836 Integrated Multimodal Assessment to Optimize Diagnosis and Surgical Selection in Idiopathic Normal Pressure Hydrocephalus
| NCT ID | NCT07427836 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico |
| Condition | Idiopathic Normal Pressure Hydrocephalus |
| Study Type | OBSERVATIONAL |
| Enrollment | 116 participants |
| Start Date | 2026-02-11 |
| Primary Completion | 2034-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 116 participants in total. It began in 2026-02-11 with a primary completion date of 2034-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07427836 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, up to 85 Years, studying Idiopathic Normal Pressure Hydrocephalus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07427836 currently recruiting?
Yes, NCT07427836 is actively recruiting participants. Contact the research team at andrea.arighi@policlinico.mi.it for enrollment information.
Where is the NCT07427836 trial being conducted?
This trial is being conducted at Milan, Italy, Milan, Italy.
Who is sponsoring the NCT07427836 clinical trial?
NCT07427836 is sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico. The trial plans to enroll 116 participants.