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 volunteersQualifiers
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
Cohort
Retrospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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).
Secondary outcomes
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.
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.
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.
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.
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