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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 116
- Locations
- 2
- Primary Endpoint
- Change in Montreal Cognitive Assessment (MoCA) total score after CSF tap test
Study Overview
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.
Detailed Description
This is an observational, non-interventional cohort study designed to assess the diagnostic and prognostic value of a multimodal approach in patients with suspected idiopathic normal pressure hydrocephalus (iNPH).
The study includes patients aged over 60 years who are referred to a standardized diagnostic, therapeutic, and care pathway for suspected iNPH at a tertiary referral center. All data are collected as part of routine clinical practice after informed consent.
Clinical data collection includes demographic and medical information, standardized neuropsychological assessments, motor performance tests, cerebrospinal fluid (CSF) analysis, and brain magnetic resonance imaging. Cognitive and motor assessments are performed before and after the CSF tap test, which is routinely used to support diagnostic and therapeutic decision-making in iNPH.
The exposed cohort consists of patients with confirmed iNPH who undergo CSF shunt surgery, while the non-exposed cohort includes patients who receive an alternative diagnosis and are managed without surgical intervention. The two groups will be compared with respect to changes in cognitive and motor performance, CSF biomarker profiles, and neuroimaging parameters.
Secondary analyses will explore associations between changes in cognitive and motor outcomes, CSF biomarkers, neuroimaging features, and surgical outcomes, including clinical response at 6 months following surgery when available within the study timeframe.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 60 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •Refusal or inability to provide informed consent.
Arms & Interventions
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.
Outcomes
Primary Outcomes
Change in Montreal Cognitive Assessment (MoCA) total score after CSF tap test
Time Frame: Baseline and 72 hours post-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(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.)
- Cerebrospinal Fluid Biomarker Profile Differences Between Surgical and Non-Surgical Patients(Baseline (at diagnostic lumbar puncture))
- Association Between Multimodal Markers and Six-Month Surgical Outcome(Baseline through 6 months post-surgery)