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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

Status: Recruiting
Location: See all (2) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 60
Maximum Age: 85
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
ACTIVE_NOT_RECRUITING
Milan
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
RECRUITING
Milan
Contact Information
Primary
Andrea Arighi, MD
andrea.arighi@policlinico.mi.it
+39 0255033814
Backup
Francesca Mameli, PsyD
francesca.mameli@policlinico.mi.it
+39 0255038671
Time Frame
Start Date: 2026-02-11
Estimated Completion Date: 2035-01
Participants
Target number of participants: 116
Treatments
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.
Sponsors
Leads: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

This content was sourced from clinicaltrials.gov