[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608442":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":27,"studyPopulation":28,"armGroups":29,"interventions":23,"overallOfficials":23,"centralContacts":36,"locations":23,"responsibleParty":42,"collaborators":44,"id":48,"slug":23,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":23,"eligibilityCriteria":53,"healthyVolunteers":54,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":23,"studyType":61,"phases":23,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":79,"whyStopped":23,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":23},{"fullName":5,"class":6},"Blekinge Institute of Technology","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":23},[9,13],{"measure":10,"description":11,"timeFrame":12},"Performance of combined model, retinal, voice and cognitive data","To assess the performance (AUC) of an optimized diagnostic model that combines HSI, OCT, and angio-OCT data with computerized cognitive testing and voice analysis for identifying Parkinson's disease","Through study completion, an average of 6 months",{"measure":14,"description":15,"timeFrame":12},"Performance retinal biomarkers","To evaluate the performance (AUC) of a diagnostic model that combines hyperspectral retinal imaging (HSI), and optimally selected data from OCT and angio-OCT, for classifying patients with Parkinson's disease",[17,20],{"measure":18,"description":19,"timeFrame":12},"Diagnostic performance of each modality on its own.","Diagnostic performance for each diagnostic modality, HSI, OCT, voice and cognitive testing",{"measure":21,"description":22,"timeFrame":12},"Correlational analyses","Correlation measures for each retinal modality with cognition and functional scale for Parkinson's disease",null,{"allocation":23,"interventionModel":23,"interventionModelDescription":23,"primaryPurpose":23,"observationalModel":25,"timePerspective":26,"maskingInfo":23},"CASE_CONTROL","CROSS_SECTIONAL","This study aims to improve how Parkinson's disease is diagnosed by testing new, non-invasive techniques that do not require spinal taps or other invasive procedures. Researchers are investigating whether changes in the eye's retina, detected with hyperspectral imaging and optical coherence tomography (OCT), can help pinpoint Parkinson's disease. These methods use special photographs and scans, similar to those performed at an eye clinic or optometrist, to analyze patterns linked to nerve cells and blood vessels in the retina.\n\nAdditionally, participants will take computerized tests to measure memory, attention, and thinking skills. Since Parkinson's disease can also affect speech, the study will analyze voice recordings for specific changes that are common in the disease, such as reduced volume and strength. By combining information from eye images, cognitive tests, and voice analysis, the project hopes to develop a faster and more accurate way to diagnose Parkinson's disease at an earlier stage.\n\nThe study is open to both people with Parkinson's disease and healthy volunteers, and the new diagnostic tools being tested could make future diagnosis simpler, more comfortable, and accessible to a wider population","Thirty consecutive patients with a diagnosis of idiopathic Parkinson's disease who are scheduled for routine follow-up visits at the Neurology Clinic in Karlskrona.\n\nAfter patient recruitment, 30 healthy controls matched by age and gender (1:1 matching) will be recruited from Blekinge Institute of Technology's (BTH) Research and Development Clinic. At the clinic, there is a list\u002Fmailbox where individuals can volunteer to participate in studies. The participants who best match the included Parkinson's patients will be invited to take part",[30,33],{"label":31,"type":23,"description":32,"interventionNames":23},"Parkinson disease","Inclusion criteria for Parkinson's group:\n\n* Age 60-80 years\n* Diagnosis of idiopathic Parkinson's disease\n* Ability to understand spoken and written Swedish\n* Ability to personally provide consent to participate in the study\n* At least one healthy eye for retinal photography",{"label":34,"type":23,"description":35,"interventionNames":23},"Healthy controls","Inclusion criteria for control group:\n\n* Age 60-80 years\n* Ability to understand spoken and written Swedish\n* Ability to personally provide consent to participate in the study\n* At least one healthy eye for retinal photography\n\nDefinition of healthy:\n\n* No diagnosed Parkinson's disease or currently under investigation for Parkinson's disease\n* No diagnosed cognitive disease or currently under investigation for cognitive disease\n* No psychiatric disease affecting cognition (e.g., psychotic disorder or major depression)\n* Cognitive testing score of MMSE ≥ 26 points (out of a maximum of 30) and ≥ 8 points on the clock-drawing test",[37],{"name":38,"role":39,"phone":40,"phoneExt":23,"email":41},"Anders Behrens, MD. PhD.","CONTACT","0046455731000","anders.behrens@bth.se",{"type":43,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR",[45],{"name":46,"class":47},"Region Blekinge","UNKNOWN","100608442",false,"NCT07201610","Non-invasive Diagnosis of Parkinson's Disease","Non-invasive Diagnosis of Parkinson's Disease Using Hyperspectral Retinal Imaging, Optical Coherence Tomography, Computerized Cognitive Testing, and Voice Analysis","Inclusion criteria for Parkinson's group:\n\n* Age 60-80 years\n* Diagnosis of idiopathic Parkinson's disease\n* Ability to understand spoken and written Swedish\n* Ability to personally provide consent to participate in the study\n* At least one healthy eye for retinal photography\n\nInclusion criteria for control group:\n\n* Age 60-80 years\n* Ability to understand spoken and written Swedish\n* Ability to personally provide consent to participate in the study\n* At least one healthy eye for retinal photography\n* Healthy as defined below\n\nExclusion criteria:\n\n* At least one eye must not have retinal disease, glaucoma, or vascular eye disease (such as embolism)\n* Angle-closure glaucoma or other contraindication to mydriatic drops\n* Low functional ability that makes participation in examinations impossible\n* Diagnosed dementia\n* Specifically for the control group: Not healthy according to the definition below\n\nDefinition of healthy:\n\n* No diagnosed or suspected Parkinson's disease\n* No diagnosed or suspected cognitive disease\n* No psychiatric disease affecting cognition (e.g., psychotic disorder or major depression)\n* Cognitive testing with MMSE ≥ 26 points (out of a maximum of 30) and ≥ 8 points on the clock-drawing test",true,"ALL","60 Years","80 Years",{"count":59,"type":60},60,"ESTIMATED","OBSERVATIONAL","This study will investigate new, non-invasive methods to help diagnose Parkinson's disease. Researchers will use advanced eye imaging (hyperspectral retinal photography and OCT), computerized memory and thinking tests, and voice analysis to identify patterns linked to Parkinson's. The goal is to improve early and accurate diagnosis of Parkinson's disease without the need for spinal taps or invasive tests.",[64],"Parkinsons Disease (PD)",[66,67,68,69,70,71,72,73,74,75,76,77,78],"Parkinson's disease","Non-invasive diagnosis","Hyperspectral retinal imaging","Optical coherence tomography","OCT","Computerized cognitive testing","Voice analysis","Biomarkers","Lewy body disease","Retinal biomarkers","Diagnostic accuracy","Neuropsychology","Machine learning","NOT_YET_RECRUITING","2025-09-30",{"date":82,"type":83},"2025-10-01","ACTUAL",{"date":85,"type":60},"2025-10-16",{"date":87,"type":60},"2025-12-16",{"name":5,"class":6}]