[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100567528":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":17,"studyPopulation":21,"armGroups":22,"interventions":17,"overallOfficials":28,"centralContacts":32,"locations":17,"responsibleParty":37,"collaborators":17,"id":39,"slug":17,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":44,"eligibilityCriteria":45,"healthyVolunteers":40,"sex":46,"minAge":47,"maxAge":17,"enrollmentInfo":48,"targetDuration":17,"studyType":51,"phases":17,"briefSummary":52,"conditions":53,"keywords":17,"overallStatus":54,"whyStopped":17,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":17},{"fullName":5,"class":6},"Neuronostics Ltd","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"To validate BioEP during routine adult EEG recording in an outpatient setting, using patients with a known diagnosis","Diagnostic accuracy, defined by a primary endpoint family1 of two ranked endpoints. Specifically, we are testing whether BioEP has superior sensitivity to initial EEG alone and is no worse than EEG alone for specificity (non-inferiority). These are ranked hypotheses with sensitivity taking precedence (fixed sequence method) . That is, we shall only proceed to comparing specificity if sensitivity is superior.","6 months",[14],{"measure":15,"description":16,"timeFrame":12},"To examine whether the use of BioEP could support a more efficient patient pathway to diagnosis","To assess if BioEP can positively influence the patient pathway by reducing number of clinical appointments to diagnosis",null,{"allocation":17,"interventionModel":17,"interventionModelDescription":17,"primaryPurpose":17,"observationalModel":19,"timePerspective":20,"maskingInfo":17},"COHORT","RETROSPECTIVE","Adult population with a diagnosis of epilepsy",[23,26],{"label":24,"type":17,"description":25,"interventionNames":17},"Epilepsy","Device: BioEP\n\nAll patient's EEG will have the BioEP score conducted on it",{"label":27,"type":17,"description":25,"interventionNames":17},"Non-epilepsy",[29],{"name":30,"affiliation":5,"role":31},"Milaana Mainstone","STUDY_DIRECTOR",[33],{"name":30,"role":34,"phone":35,"phoneExt":17,"email":36},"CONTACT","+44 (0)117 457 2292","m.mainstone@neuronostics.com",{"type":38,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"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":49,"type":50},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.",[24],"NOT_YET_RECRUITING","2024-10-30",{"date":57,"type":58},"2024-11-01","ACTUAL",{"date":60,"type":50},"2025-01-01",{"date":62,"type":50},"2025-03-01",{"name":5,"class":6}]