[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625838":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":41,"studyPopulation":42,"armGroups":43,"interventions":37,"overallOfficials":37,"centralContacts":50,"locations":60,"responsibleParty":86,"collaborators":37,"id":88,"slug":37,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":89,"sex":95,"minAge":96,"maxAge":97,"enrollmentInfo":98,"targetDuration":37,"studyType":101,"phases":37,"briefSummary":102,"conditions":103,"keywords":105,"overallStatus":63,"whyStopped":37,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":37},[9],{"measure":10,"description":11,"timeFrame":12},"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",[14,17,20,23,26,29,33],{"measure":15,"description":16,"timeFrame":12},"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.",{"measure":18,"description":19,"timeFrame":12},"Change in Go\u002FNo-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.",{"measure":21,"description":22,"timeFrame":12},"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.",{"measure":24,"description":25,"timeFrame":12},"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.",{"measure":27,"description":28,"timeFrame":28},"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.",{"measure":30,"description":31,"timeFrame":32},"Cerebrospinal Fluid Biomarker Profile Differences Between Surgical and Non-Surgical Patients","Comparison of CSF biomarker concentrations measured at diagnostic lumbar puncture, including Aβ42, Aβ40, total tau, phosphorylated tau, Aβ42\u002FAβ40 ratio, p-tau\u002FAβ42 ratio, and aquaporin-4. Analyses will evaluate differences between patients undergoing CSF shunt surgery and those receiving an alternative diagnosis without surgery.","Baseline (at diagnostic lumbar puncture)",{"measure":34,"description":35,"timeFrame":36},"Association Between Multimodal Markers and Six-Month Surgical Outcome","Correlation between pre- to post-tap-test changes in cognitive and motor measures, CSF biomarkers, neuroimaging parameters, and clinical response at 6 months following CSF shunt surgery.","Baseline through 6 months post-surgery",null,{"allocation":37,"interventionModel":37,"interventionModelDescription":37,"primaryPurpose":37,"observationalModel":39,"timePerspective":40,"maskingInfo":37},"COHORT","RETROSPECTIVE","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).\n\nThe 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.\n\nClinical 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.\n\nThe 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.\n\nSecondary 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.\n\nThe study combines prospectively collected data with retrospectively available clinical data to provide a comprehensive characterization of patients with suspected iNPH and to support improved diagnostic accuracy and surgical candidate selection.","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.",[44,47],{"label":45,"type":37,"description":46,"interventionNames":37},"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.",{"label":48,"type":37,"description":49,"interventionNames":37},"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.",[51,56],{"name":52,"role":53,"phone":54,"phoneExt":37,"email":55},"Andrea Arighi, MD","CONTACT","+39 0255033814","andrea.arighi@policlinico.mi.it",{"name":57,"role":53,"phone":58,"phoneExt":37,"email":59},"Francesca Mameli, PsyD","+39 0255038671","francesca.mameli@policlinico.mi.it",[61,79],{"facility":62,"status":63,"city":64,"state":37,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico","RECRUITING","Milan","20122","Italy","IT",{"type":69,"coordinates":70},"Point",[71,72],9.18951,45.46427,{"lat":72,"lon":71},[75],{"name":76,"role":53,"phone":77,"phoneExt":37,"email":78},"Milena Scauso","+39-02-5503-6197","milena.scauso@policlinico.mi.it",{"facility":62,"status":80,"city":64,"state":37,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":81,"geoPoint":85,"contacts":37},"ACTIVE_NOT_RECRUITING",{"type":69,"coordinates":82},[83,84],12.59836,42.78235,{"lat":84,"lon":83},{"type":87,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR","100625838",false,"NCT07427836","Integrated Multimodal Assessment to Optimize Diagnosis and Surgical Selection in Idiopathic Normal Pressure Hydrocephalus","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","NPH-OPTIMIZE","Inclusion Criteria:\n\n* Age 60 years or older.\n* Patients with suspected idiopathic normal pressure hydrocephalus referred to the institutional diagnostic, therapeutic, and care pathway.\n* Ability to provide written informed consent.\n\nExclusion Criteria:\n\n* Refusal or inability to provide informed consent.","ALL","60 Years","85 Years",{"count":99,"type":100},116,"ESTIMATED","OBSERVATIONAL","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.\n\nThis 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.\n\nPatients 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.\n\nThe 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.",[104],"Idiopathic Normal Pressure Hydrocephalus",[106,107,108,109],"Cognition","CSF biomarkers","CSF tap test","Gait assessment","2026-02-16",{"date":112,"type":113},"2026-02-23","ACTUAL",{"date":115,"type":100},"2026-02-11",{"date":117,"type":100},"2035-01",{"name":5,"class":6},2]