[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Epiminder America, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":68},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100601426","diagnosing-epilepsy-to-effect-change-100601426",false,"NCT07110337","Diagnosing Epilepsy To EffeCT Change","A Prospective Study to Evaluate the Use of the Minder Device to Aid in Developing a Treatment Plan After Inconclusive Prolonged EEG in Patients With Epilepsy","DETECT","Inclusion Criteria:\n\n* Diagnosis of focal and\u002For generalized epilepsy.\n* Drug-resistant\n* At least an average of 1 seizure within the past 3 months\n* Participant completed a multi-day EEG assessment that was inconclusive, and is unchanged since the last EEG monitoring.\n\nExclusion Criteria:\n\n* Epilepsy surgery within the past 6 months\n* Active Deep Brain Stimulation (DBS) or Responsive Neurostimulator System (RNS)\n* Participant needs treatments or assessments that are not indicated with the Minder System like Magnetic Resonance Imaging (MRI), Electro-Convulsive Therapy (ECT), lithrotripsy, and diathermy\n* Participant cannot have surgery to have the device implanted","ALL","18 Years","75 Years",{"count":21,"type":22},210,"ESTIMATED","INTERVENTIONAL",[25],"NA","The purpose of this research is to address the challenges of diagnosing and long-term management of epilepsy in participants whose seizures are not well captured by standard electroencephalography (EEG) tests and who cannot use or are not able to use more standard monitoring techniques. This research will compare the Minder System to standard of care in providing reliable seizure data. The Minder System was granted De Novo classification by the U.S. Food and Drug Administration (FDA) and is not investigational.\n\nParticipants will consent to join the study and be implanted with the Minder device; or consent to join the study and continue with their Standard of Care (SOC) as a control group. Participants chose to be implanted with the Minder device will have the device implanted under their scalp. After implantation, participants will be randomly assigned to a group where their treating physician will have access to the EEG data collected by the Minder System or a group where their treating physician does not have access to the EEG data collected by the Minder System. Participants receiving the Minder System will not know which group they are in (blinded) until the study ends.\n\nAll participants will continue to be followed by their treating physician and undergo assessments and visits until enough information is available to determine a treatment plan or the 6-month follow-up visit.",[28,29],"Epilepsy","Epilepsy (Treatment Refractory)",[31,32],"Minder System","Sub-scalp EEG monitoring device","RECRUITING","2026-06-03",{"date":36,"type":37},"2026-06-04","ACTUAL",{"date":39,"type":37},"2025-12-23",{"date":41,"type":22},"2027-06",{"name":43,"class":44},"Epiminder America, Inc.","INDUSTRY",18,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":54,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":56,"conditions":57,"keywords":58,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},"100601435","diagnosing-epilepsy-to-effect-change-long-term-follow-up-100601435","NCT07110454","Diagnosing Epilepsy To EffeCT Change Long-Term Follow-Up","A Prospective Long-Term Follow-Up Study to Evaluate the Use of the Minder Device to Aid in Treatment After Actionable Event Identification in Patients Diagnosed With Epilepsy.","DETECT LTFU","Inclusion Criteria:\n\n* Participant met all inclusion criteria, was enrolled in the DETECT study, and received the Minder device\n* Participant completed the DETECT study by receiving an actionable event or by completing the 6-month follow-up visit\n* Participant continues to have the Minder device implanted\n* Participant must continue to meet relevant DETECT study inclusion criteria\n\nExclusion Criteria:\n\n* Participant meets any relevant DETECT study exclusion criteria including needing treatments or assessments that are not indicated with the Minder System like Magnetic Resonance Imaging (MRI)",{"count":21,"type":22},"OBSERVATIONAL","The purpose of this research is to address the challenges of correctly monitoring, managing, and diagnosing epilepsy in participants whose seizures are not well captured by standard electroencephalography (EEG) tests and who cannot use or are not able to use more standard monitoring techniques. This research is being done to understand how the Minder System helps physicians make decisions about participant's epilepsy treatment after an actionable event. The Minder System was granted De Novo classification by the U.S. Food and Drug Administration (FDA) and is not investigational.\n\nParticipants that have completed the DETECT study and received the Minder System previously will consent to join this long-term follow-up observational study. The study will collect information about general wellbeing, use of healthcare services, and experience using the Minder data over time to support long-term epilepsy care.\n\nAll participants will continue to be followed by their treating physician and undergo assessments and visits every six (6) months until two (2) years after receiving the Minder device.",[28,29],[31,32],"2026-05-15",{"date":61,"type":37},"2026-05-18",{"date":63,"type":22},"2026-06",{"date":65,"type":22},"2029-01",{"name":43,"class":44},12,""]