[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648193":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":36,"centralContacts":40,"locations":48,"responsibleParty":70,"collaborators":10,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":81,"sex":82,"minAge":83,"maxAge":10,"enrollmentInfo":84,"targetDuration":10,"studyType":87,"phases":10,"briefSummary":88,"conditions":89,"keywords":95,"overallStatus":51,"whyStopped":10,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"IRCCS San Raffaele","OTHER",[8,14,18,22,26],{"label":9,"type":10,"description":11,"interventionNames":12},"Multiple Sclerosis patients",null,"210 patients with a diagnosis of Multiple Sclerosis according to current diagnostic criteria, stratified into three age subgroups (20-40, 40-60, and over 60 years, 70 per subgroup). Undergo OCT at baseline and follow-up visits at 6, 12, 18, and\u002For 24 months, alongside standard clinical assessments including EDSS.",[13],"Device: Optical Coherence Tomography (OCT) - Heidelberg SPECTRALIS HRA+OCT",{"label":15,"type":10,"description":16,"interventionNames":17},"Alzheimer's disease patients","210 patients with a diagnosis of Alzheimer's disease according to current diagnostic criteria, stratified into three age subgroups (70 per subgroup). Undergo OCT at baseline and follow-up visits alongside standard neuropsychological assessments, brain MRI, PET, and CSF biomarkers as part of routine clinical care.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Parkinson's disease patients","210 patients with a diagnosis of Parkinson's disease according to current diagnostic criteria, stratified into three age subgroups (70 per subgroup). Undergo OCT at baseline and follow-up visits alongside standard clinical assessments including UPDRS.",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Migraine and headache patients","210 patients with a diagnosis of migraine or headache according to current diagnostic criteria, stratified into three age subgroups (70 per subgroup). Undergo OCT at baseline and follow-up visits alongside standard clinical assessments.",[13],{"label":27,"type":10,"description":28,"interventionNames":29},"Healthy Controls","210 healthy subjects without neurological disease, age-matched to patients, stratified into three age subgroups (20-40, 40-60, and over 60 years, 70 per subgroup). Recruited primarily from medical students, colleagues, and relatives of patients. Undergo OCT at baseline and follow-up visits.",[13],[31],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":10},"DEVICE","Optical Coherence Tomography (OCT) - Heidelberg SPECTRALIS HRA+OCT","Spectral-domain Optical Coherence Tomography (OCT) performed using the Heidelberg SPECTRALIS HRA+OCT device (Class IIa CE-marked medical device). The procedure is non-invasive: the patient sits in front of the device and is asked to fix a target (light or cross) through a lens. No drugs or contrast agents are administered. OCT automatically acquires images of the macular region (where GCL and IPL are most represented) and the optic nerve head region (where RNFL is most represented), providing automated measurements of the thickness of individual retinal layers.\n\nOCT is performed at baseline and at follow-up visits at 6, 12, 18, and\u002For 24 months. Ophthalmological evaluation may be performed at the investigators' discretion if OCT images, clinical symptoms, or medical history suggest concurrent ocular pathology. Patients with a known diagnosis of epilepsy or history of epileptic seizures will not undergo specific imaging modes using clearly visible light sources (MultiColor, FA, BAF).",[15,27,23,9,19],[37],{"name":38,"affiliation":5,"role":39},"Massimo Filippi, Prof, MD","PRINCIPAL_INVESTIGATOR",[41,46],{"name":42,"role":43,"phone":44,"phoneExt":10,"email":45},"Federica Agosta, MD","CONTACT","0226433051","agosta.federica@hsr.it",{"name":47,"role":43,"phone":10,"phoneExt":10,"email":10},"Roberto Santangelo, MD",[49],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"IRCCS Ospedale San Raffaele - Neurology and Neurophysiology Unit","RECRUITING","Milan","Milano","20132","Italy","IT",{"type":58,"coordinates":59},"Point",[60,61],12.59836,42.78235,{"lat":61,"lon":60},[64,65,66,67,69],{"name":42,"role":43,"phone":44,"phoneExt":10,"email":45},{"name":47,"role":43,"phone":10,"phoneExt":10,"email":10},{"name":38,"role":39,"phone":10,"phoneExt":10,"email":10},{"name":42,"role":68,"phone":10,"phoneExt":10,"email":10},"SUB_INVESTIGATOR",{"name":47,"role":68,"phone":10,"phoneExt":10,"email":10},{"type":39,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Prof. Massimo Filippi","Prof, MD","100648193","optical-coherence-tomography-in-neurological-practice-utility-and-applicability-across-neurological-diseases-octinn-100648193",false,"NCT07720765","Optical Coherence Tomography in Neurological Practice: Utility and Applicability Across Neurological Diseases (OCt.IN.N)","A National, Monocentric, Prospective Cohort Study to Evaluate the Utility and Applicability of Optical Coherence Tomography in Neurological Clinical Practice","OCT","Inclusion Criteria for neurological patients:\n\n1. Diagnosis of a Central Nervous System neurological disease (inflammatory diseases such as Multiple Sclerosis; neurodegenerative diseases such as Alzheimer's disease and Parkinson's disease; migraine\u002Fheadache) according to currently accepted diagnostic criteria for each condition.\n2. Age greater than 18 years.\n3. Signed informed consent to study participation.\n4. Willingness and ability to undergo all study visits and procedures.\n\nInclusion Criteria for healthy controls:\n\n1. Absence of neurological disease.\n2. Age greater than 18 years.\n3. Signed informed consent to study participation.\n4. Willingness and ability to undergo all study visits and procedures.\n\nExclusion Criteria for neurological patients:\n\n1. Refusal to participate or withdrawal of informed consent.\n2. Known or confirmed ocular pathology identified during examination (ophthalmological evaluation may be requested at the investigators' discretion).\n3. Inability to understand instructions given by investigators.\n4. Presence of any condition that, in the investigators' opinion, renders the subject unsuitable for the study.\n5. For specific imaging modes using clearly visible light sources (MultiColor, FA, BAF): diagnosis of epilepsy or history of previous epileptic seizures.\n\nExclusion Criteria for healthy controls:\n\n1. Refusal to participate or withdrawal of informed consent.\n2. Known or confirmed ocular pathology identified during examination.\n3. Inability to understand instructions given by investigators.\n4. Presence of any condition that, in the investigators' opinion, renders the subject unsuitable for the study.",true,"ALL","18 Years",{"count":85,"type":86},1050,"ESTIMATED","OBSERVATIONAL","OCt.IN.N is a national, monocentric, prospective, observational cohort study evaluating the utility and applicability of Optical Coherence Tomography (OCT) in the diagnostic workup and longitudinal monitoring of neurological diseases.\n\n840 patients with Central Nervous System neurological diseases (Multiple Sclerosis, Alzheimer's disease, Parkinson's disease, migraine\u002Fheadache) and 210 age-matched healthy controls will undergo OCT examination at baseline and at 6, 12, 18, and 24 months of follow-up at IRCCS San Raffaele Hospital, Milan, Italy.\n\nOCT is a non-invasive, rapid, and reproducible technique that automatically measures the thickness of individual retinal layers. Retinal layer thicknesses and their longitudinal changes will be correlated with established clinical scales, neuroimaging, and biological markers used in routine neurological practice.",[90,91,92,93,94],"Multiple Sclerosis","Alzheimer Disease","Parkinson Disease","Migraine","Headache Disorders",[96,79,97,98,99,100,90,101,102,93,103,104,105],"Optical Coherence Tomography","Retinal nerve fiber layer","RNFL","Ganglion cell layer","GCL","Alzheimer's disease","Parkinson's disease","Neurodegeneration","Neuro-retina","Biomarker","2026-07-17",{"date":108,"type":109},"2026-07-22","ACTUAL",{"date":111,"type":109},"2023-10-09",{"date":113,"type":86},"2031-04-01",{"name":5,"class":6},1]