Integrated Multimodal Assessment to Optimize Diagnosis and Surgical Selection in Idiopathic Normal Pressure Hydrocephalus
Recruiting now
Conditions studied: Idiopathic Normal Pressure Hydrocephalus
In brief
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.
Key facts
- Study ID
- NCT07427836
- Run by
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- People needed
- 116
- Starts
- 2026-02-11
- Expected to finish
- 2035-01-01
- Last updated by the study team
- 2026-02-23
Who can join
Age: 60 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Refusal or inability to provide informed consent.
Where it is running
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico — Milan, Italy (enrolling)
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico — Milan, Italy
Full record on ClinicalTrials.gov
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