Integrated Multimodal Assessment to Optimize Diagnosis and Surgical Selection in Idiopathic Normal Pressure Hydrocephalus

NCT07427836 | Recruiting

• 1 other identifier: 0048426-U
• Study Type: observational
• Target: 116
• Locations: 1 country
• Sites: 2

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.

Conditions

Idiopathic Normal Pressure Hydrocephalus

Keywords

Cognition; CSF biomarkers; CSF tap test; Gait assessment

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline and 72 hours post-CSF tap test

Secondary Outcomes (7)

• Change in Simple Visual Reaction Time After CSF Tap Test

  Baseline and 72 hours post-CSF tap test

• Change in Go/No-Go Test Accuracy After CSF Tap Test

  Baseline and 72 hours post-CSF tap test

• Change in Timed Up and Go (TUG) Test Score After CSF Tap Test

  Baseline and 72 hours post-CSF tap test

• Change in Short Physical Performance Battery (SPPB) Score After CSF Tap Test

  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.

Study Arms (2)

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.

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

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.

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (2)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

RECRUITING

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

ACTIVE NOT RECRUITING

Central Study Contacts

Andrea Arighi, MD

CONTACT

+39 0255033814; andrea.arighi@policlinico.mi.it

Francesca Mameli, PsyD

CONTACT

+39 0255038671; francesca.mameli@policlinico.mi.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 23, 2026
• Study Start: February 11, 2026
• Primary Completion (Estimated): July 1, 2034
• Study Completion (Estimated): January 1, 2035
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)