[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100523554":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":25,"studyPopulation":18,"armGroups":26,"interventions":37,"overallOfficials":43,"centralContacts":47,"locations":55,"responsibleParty":81,"collaborators":18,"id":83,"slug":18,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":84,"sex":90,"minAge":91,"maxAge":18,"enrollmentInfo":92,"targetDuration":18,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":18,"overallStatus":58,"whyStopped":18,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Neuronostics Ltd","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"The primary outcome is epilepsy diagnosis (yes\u002Fno) at baseline.","The epilepsy diagnosis timepoint is defined as the diagnostic decision of the clinician after the continuous process of information gathering, integration, and interpretation and deciding that sufficient information has been gathered to make a definitive judgment. Initial suspicions of a provoked or isolated seizure leading to a watch-and-wait strategy are not regarded as a epilepsy diagnosis.","Baseline",[14],{"measure":15,"description":16,"timeFrame":17},"Accuracy of the BioEP score in predicting subsequent confirmation of epilepsy","The accuracy of the initial BioEP score will be evaluated prospectively","1 year and 2 year",null,{"allocation":20,"interventionModel":21,"interventionModelDescription":18,"primaryPurpose":22,"observationalModel":18,"timePerspective":18,"maskingInfo":23},"RANDOMIZED","PARALLEL","DIAGNOSTIC",{"masking":24,"maskingDescription":18,"whoMasked":18},"NONE","Neuronostics will conduct a two-arm randomised control trial with two groups: (i) Usual Care, (ii) Usual Care + BioEP score and report. In this context, usual care involves clinical\u002F patient history, eye-witness accounts and any standard tests ordered (electroencephalogram (EEG), Magnetic Resonance Imaging (MRI), blood tests etc.). Investigators will recruit adults attending first seizure clinics where there is a suspicion that epilepsy is the causing symptoms and so a first EEG is recommended. Participants will be sourced from 10 sites. The trial duration will be 1 year recruitment, and 2 year follow up period.\n\nRandomisation: Consenting individual patients will be randomly assigned to either Usual Care or Usual Care + BioEP in a 1:1 ratio. Randomisation will be stratified by centre, with eligible and consenting participants allocated in random blocks. The allocation schedule will be generated by the trial statistician, and concealed from the clinicians assessing eligibility and recruiting patients.",[27,31],{"label":28,"type":29,"description":30,"interventionNames":18},"Usual Care","NO_INTERVENTION","Participant has usual care",{"label":32,"type":33,"description":34,"interventionNames":35},"Usual Care + BioEP","OTHER","Participant has usual care + BioEP algorithm on their EEG",[36],"Device: BioEP",[38],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":18},"DEVICE","BioEP","When a consenting participant has their first electroencephalogram (EEG), they will be assigned with a unique participant study identifier before being uploaded. The centre will convert the EEG to European Data Format (EDF) format (or upload the total file) and upload this to the Neuronostics platform. The EEG will be stored on the Neuronostics database management system, within which the computational and mathematical analysis will be carried out. This study involves data analysis and mathematical modelling of the EEG recordings of each patient individually to generate a computational analysis score (BioEP).",[32],[44],{"name":45,"affiliation":5,"role":46},"Wessel Woldman","STUDY_DIRECTOR",[48,52],{"name":45,"role":49,"phone":50,"phoneExt":18,"email":51},"CONTACT","+44 (0)117 457 2292","w.woldman@neuronostics.com",{"name":53,"role":49,"phone":18,"phoneExt":18,"email":54},"Verity Fuller","v.fuller@neuronostics.com",[56,71],{"facility":57,"status":58,"city":59,"state":18,"zip":18,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"Royal Cornwall Hospitals Trust","RECRUITING","Truro","United Kingdom","UK",{"type":63,"coordinates":64},"Point",[65,66],-5.05436,50.26526,{"lat":66,"lon":65},[69],{"name":70,"role":49,"phone":18,"phoneExt":18,"email":18},"Milaana Mainstone",{"facility":72,"status":58,"city":73,"state":18,"zip":18,"country":60,"countryCode":61,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"The Royal Wolverhampton NHS Trust","Wolverhampton",{"type":63,"coordinates":75},[76,77],-2.12296,52.58547,{"lat":77,"lon":76},[80],{"name":70,"role":49,"phone":18,"phoneExt":18,"email":18},{"type":82,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100523554",false,"NCT06097195","The Clinical Utility of BioEP in Diagnostic Decision Making in Epilepsy","A Multi-centre, Prospective, Two-arm Randomised Controlled Trial to Determine the Clinical Utility of BioEP in Diagnostic Decision Making in Epilepsy","CITADEL","Inclusion Criteria:\n\n* Adult (age 18 and above) presenting with first suspected seizure(s)\n* Able to give informed consent\n* Patient receives EEG following clinicians' decision to refer for an EEG based on clinical history and seizure description taken during first seizure clinic.\n* Non-contributory EEG only (i.e. no specific diagnostic abnormalities present such as interictal epileptiform discharges)\n\nExclusion Criteria:\n\n* Participants unable to tolerate an EEG test so no EEG data were gathered\n* Participants with a known hepatic\u002Frenal encephalopathy\n* Participants that upon history taking have a clear clinical diagnosis of a physical condition other than epilepsy (e.g. vasovagal syncope)","ALL","18 Years",{"count":93,"type":94},559,"ESTIMATED","INTERVENTIONAL",[97],"NA","Neuronostics plan a prospective multisite trial to determine the clinical utility of BioEP in the context of diagnostic decision making. Neuronostics will use findings from the trial to improve user experience of the Neuronostics platform (the tool which clinicians use to obtain a BioEP score from EEG and the aligned report). The data coming from the trial will also enable Neuronostics to iterate the BioEP algorithms and so improve future performance.",[100],"Epilepsy","2026-04-16",{"date":103,"type":104},"2026-04-21","ACTUAL",{"date":106,"type":104},"2024-05-21",{"date":108,"type":94},"2026-12-31",{"name":5,"class":6},2]