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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60-85
SponsorFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Refusal or inability to provide informed consent.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

116 Participants
are grouped into 2 trial groups
Group A: Idiopathic Normal Pressure Hydrocephalus - Surgical Cohort
Group B: Non-Surgical Comparison Cohort

Trial outcomes

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).

Time frame
Baseline and 72 hours post-CSF tap test

Secondary outcomes

1

Change in Simple Visual Reaction Time After CSF Tap Test

Difference in mean reaction time (milliseconds) between baseline and 72 hours after CSF tap test. Lower values indicate better performance.

Time frame
Baseline and 72 hours post-CSF tap test
2

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

Difference in response accuracy (%) between baseline and 72 hours after CSF tap test. Higher percentages indicate better inhibitory control and executive function.

Time frame
Baseline and 72 hours post-CSF tap test
3

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

Difference in time required to complete the Timed Up and Go test (seconds) between baseline and 72 hours after CSF tap test. Lower times indicate better mobility performance.

Time frame
Baseline and 72 hours post-CSF tap test
4

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

Difference in SPPB total score (range 0-12) between baseline and 72 hours after CSF tap test. Higher scores indicate better lower-extremity function.

Time frame
Baseline and 72 hours post-CSF tap test

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.