[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100523554":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":37,"responsibleParty":63,"collaborators":12,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":12,"enrollmentInfo":75,"targetDuration":12,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":12,"overallStatus":40,"whyStopped":12,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Neuronostics Ltd","INDUSTRY",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Usual Care","NO_INTERVENTION","Participant has usual care",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Usual Care + BioEP","OTHER","Participant has usual care + BioEP algorithm on their EEG",[18],"Device: BioEP",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"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).",[14],[26],{"name":27,"affiliation":5,"role":28},"Wessel Woldman","STUDY_DIRECTOR",[30,34],{"name":27,"role":31,"phone":32,"phoneExt":12,"email":33},"CONTACT","+44 (0)117 457 2292","w.woldman@neuronostics.com",{"name":35,"role":31,"phone":12,"phoneExt":12,"email":36},"Verity Fuller","v.fuller@neuronostics.com",[38,53],{"facility":39,"status":40,"city":41,"state":12,"zip":12,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Royal Cornwall Hospitals Trust","RECRUITING","Truro","United Kingdom","UK",{"type":45,"coordinates":46},"Point",[47,48],-5.05436,50.26526,{"lat":48,"lon":47},[51],{"name":52,"role":31,"phone":12,"phoneExt":12,"email":12},"Milaana Mainstone",{"facility":54,"status":40,"city":55,"state":12,"zip":12,"country":42,"countryCode":43,"cosmosGeoPoint":56,"geoPoint":60,"contacts":61},"The Royal Wolverhampton NHS Trust","Wolverhampton",{"type":45,"coordinates":57},[58,59],-2.12296,52.58547,{"lat":59,"lon":58},[62],{"name":52,"role":31,"phone":12,"phoneExt":12,"email":12},{"type":64,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR","100523554","the-clinical-utility-of-bioep-in-diagnostic-decision-making-in-epilepsy-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":76,"type":77},559,"ESTIMATED","INTERVENTIONAL",[80],"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.",[83],"Epilepsy","2026-04-16",{"date":86,"type":87},"2026-04-21","ACTUAL",{"date":89,"type":87},"2024-05-21",{"date":91,"type":77},"2026-12-31",{"name":5,"class":6},2]