[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Neuronostics Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":106},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,41,64,84],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"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":20,"type":21},559,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27],"Epilepsy","RECRUITING","2026-04-16",{"date":31,"type":32},"2026-04-21","ACTUAL",{"date":34,"type":32},"2024-05-21",{"date":36,"type":21},"2026-12-31",{"name":38,"class":39},"Neuronostics Ltd","INDUSTRY",2,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":4},"100567528","a-retrospective-study-to-validate-bioep-as-an-assessment-aid-for-seizure-susceptibility-100567528","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.","22 Years",{"count":51,"type":21},400,"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.",[27],"NOT_YET_RECRUITING","2024-10-30",{"date":58,"type":32},"2024-11-01",{"date":60,"type":21},"2025-01-01",{"date":62,"type":21},"2025-03-01",{"name":38,"class":39},{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":74,"conditions":75,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":4},"100543361","a-study-to-assess-utility-of-bioep-as-an-early-prognostic-indicator-for-predicting-anti-seizure-medication-asm-efficacy-100543361","NCT06354868","A Study to Assess utiLity of BIoEP as an Early Prognostic Indicator for Predicting Anti-Seizure Medication (ASM) Efficacy","A Prospective Observational Clinical Study to Investigate the Relationship Between Seizure Frequency and BioEP During ASM Titration in Newly Diagnosed Patients With Epilepsy, and to Assess the Utility of BioEP as an Early Prognostic Indicator of Anti-seizure Medication (ASM) Efficacy","ECLIPSE","Inclusion Criteria:\n\n* Adult (age 18 and above) presenting with first suspected seizure(s).\n* Able to give informed consent.\n* Patient has received an initial epilepsy diagnosis.\n* Patient accepts decision to commence ASM.\n* Have an EEG prior to commencing ASMs.\n* Participants under watchful waiting who subsequently return to clinic for an epilepsy diagnosis (following a second seizure or a positive EEG) can be included in the study. They must have had an EEG performed in the 12 months prior to be being included in the study (to be used as a baseline EEG) and not have been taking any ASMs at the time.\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* Patient diagnosed with possible NEAD and epilepsy (dual diagnosis).\n* Participants taking part in another Clinical Trial of an Investigational Medicinal Product (CTIMP) (qualitative\u002Fobservational studies are acceptable).\n* Patient receiving low does ASMs for other conditions (migraines etc).",{"count":73,"type":21},158,"This multisite prospective clinical study is to investigate the relationship between seizure type and frequency with the BioEP result during ASM titration in newly diagnosed patients with epilepsy, and to assess the utility of BioEP as an early prognostic indicator of ASM efficacy",[27],"2024-08-12",{"date":78,"type":32},"2024-08-13",{"date":80,"type":21},"2024-09",{"date":82,"type":21},"2027-06",{"name":38,"class":39},{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":17,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":96,"conditions":97,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":103,"leadSponsor":105,"locationsCount":4},"100558076","oasis-retrospective-analysis-on-eegs-for-identifying-seizure-susceptibility-in-paediatrics-using-biomarkers-100558076","NCT06546410","OASIS: RetrOspective Analysis on EEGs for Identifying Seizure Susceptibility in paediatrIcs Using biomarkerS","A Retrospective Multisite Analysis of Routinely Collected Outpatient EEGs for Identifying Seizure Susceptibility in Paediatric Epilepsy Using Computational Biomarkers.","OASIS","Inclusion Criteria:\n\n* ≥2-\\\u003C18 years age.\n* Patients who have had a confirmed epilepsy diagnosis for ≥1+ year.\n* Non contributary first EEG: including routine EEG, sleep EEG (natural, melatonin induced, sleep deprived), 24-hour ambulatory EEG.\n* Patients who have been diagnosed with a self-limited and or focal epilepsy \\[\\*\\] who have had a first non-contributary (no IEDS present, negative) outpatient EEG.\n* Patients who have been diagnosed with idiopathic generalised epilepsy \\[†\\] who have had a first non-contributary (no IEDS present, negative) routine EEG.\n* Neurodiverse patients with epilepsy can be included in the study \\[‡\\]\n* Patients with epilepsy and co-morbidities can be included in the study (anxiety, mood disorders etc)\n* Controls should be EEGs taken from patients who have been referred for a paroxysmal disorder, received an EEG as part of their diagnostic work up and subsequently received an alternate diagnosis. Epilepsy should have been excluded from their differential diagnosis and the alternate diagnosis should have remained stable for ≥1+ year.\n\nExclusion Criteria:\n\n* Developmental and\u002For epileptic encephalopathies \\[§\\]\n* Patients with global development delay of unknown origin.\n* Patients with profound and multiple intellectual disabilities\n* Participants with a known hepatic\u002Frenal encephalopathy.\n* Patient diagnosed with possible NEAD and epilepsy (dual diagnosis).\n* Participants taking part in another Clinical Trial of an Investigational Medicinal Product (CTIMP) (qualitative\u002Fobservational studies are acceptable).\n* Patients with any breaches of skull (plates, burr holes, shrapnel).","2 Years","16 Years",{"count":95,"type":21},500,"The goal of this retrospective study is to validate a set of computational biomarkers (BioEP) for seizure susceptibility on retrospective routinely collected non-contributory EEGs in paediatric participants with epilepsy. The main objectives are:\n\nPrimary:\n\nTo validate a set of computational biomarkers (BioEP) for seizure susceptibility on retrospective routinely collected non-contributory EEGs in paediatric participants with epilepsy.\n\nSecondary:\n\nTo 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",[27,98],"Epilepsy in Children","2024-08-06",{"date":101,"type":32},"2024-08-09",{"date":60,"type":21},{"date":104,"type":21},"2026-01-01",{"name":38,"class":39},""]