[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100567528":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":14,"centralContacts":18,"locations":10,"responsibleParty":23,"collaborators":10,"id":25,"slug":10,"hasResults":26,"nctId":27,"briefTitle":28,"officialTitle":29,"acronym":30,"eligibilityCriteria":31,"healthyVolunteers":26,"sex":32,"minAge":33,"maxAge":10,"enrollmentInfo":34,"targetDuration":10,"studyType":37,"phases":10,"briefSummary":38,"conditions":39,"keywords":10,"overallStatus":40,"whyStopped":10,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":10},{"fullName":5,"class":6},"Neuronostics Ltd","INDUSTRY",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Epilepsy",null,"Device: BioEP\n\nAll patient's EEG will have the BioEP score conducted on it",{"label":13,"type":10,"description":11,"interventionNames":10},"Non-epilepsy",[15],{"name":16,"affiliation":5,"role":17},"Milaana Mainstone","STUDY_DIRECTOR",[19],{"name":16,"role":20,"phone":21,"phoneExt":10,"email":22},"CONTACT","+44 (0)117 457 2292","m.mainstone@neuronostics.com",{"type":24,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100567528",false,"NCT06669364","A Retrospective Study to Validate BioEP as an Assessment Aid for Seizure Susceptibility","Retrospective Analysis of Routine EEG to Validate a Computational Biomarker (BioEP) as an Assessment Aid for Seizure Susceptibility.","SOLITAIRE","Inclusion Criteria:\n\n* Adults (age 22 and above) who had a routine EEG in an outpatient setting, following a suspected seizure.\n* A diagnosis of epilepsy or alternate condition has been reached. A period of at least 3 years has passed since ultimate diagnosis, which itself has remained stable.\n* EEGs performed to ABRET \\& IFCN standards using a minimum of 19 electrodes and additional technical requirements.\n\nExclusion Criteria:\n\n* Subject was not suspected of having had a seizure or epilepsy.\n* Subject has a dual diagnosis of epilepsy AND non-epileptic seizures.\n* Subject's final diagnosis unknown, unstable, or less than three years passed since an unchanged diagnosis was made.\n* Incomplete or unreliable metadata, such as the age, sex, and treatment status at the time of the EEG recording.\n* Sleep deprived EEG recordings in the outpatient setting.\n* Encephalopathic subjects.\n* Poor quality EEGs (multiple artefacts) that do not fulfil technical criteria for analysis.\n* Known structural abnormalities or skull breaches, including historical cases, or with people with metal or plastic implants in their brain or skull.","ALL","22 Years",{"count":35,"type":36},400,"ESTIMATED","OBSERVATIONAL","The goal of this retrospective study is to validate BioEP during routine adult EEG recording in an outpatient setting, using patients with a known epilepsy diagnosis. The main objectives of the study are:\n\n* To validate BioEP during routine adult EEG recording in an outpatient setting, using patients with a known diagnosis\n* To examine whether the use of BioEP could support a more efficient patient pathway to diagnosis (thus adding economic value), by reducing time to final diagnosis and\u002For the number of clinical appointments needed.",[9],"NOT_YET_RECRUITING","2024-10-30",{"date":43,"type":44},"2024-11-01","ACTUAL",{"date":46,"type":36},"2025-01-01",{"date":48,"type":36},"2025-03-01",{"name":5,"class":6}]