[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656169":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":13,"studyPopulation":13,"armGroups":20,"interventions":27,"overallOfficials":13,"centralContacts":33,"locations":39,"responsibleParty":58,"collaborators":13,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":13,"enrollmentInfo":69,"targetDuration":13,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":13,"overallStatus":78,"whyStopped":13,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Adraxe Corp.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Event-Level Seizure Detection by Subgaleal EEG Compared With SEEG","The proportion of clinically adjudicated SEEG seizures for which a corresponding event is identified on simultaneously recorded subgaleal EEG (sgEEG). SEEG serves as the reference standard.","During concurrent sgEEG and standard-of-care SEEG monitoring, up to 14 days",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"NA","SINGLE_GROUP","OTHER",{"masking":19,"maskingDescription":13,"whoMasked":13},"NONE",[21],{"label":22,"type":23,"description":24,"interventionNames":25},"Single arm","EXPERIMENTAL","Record only",[26],"Device: EEG Record only",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":13},"DEVICE","EEG Record only","Subgaleal EEG recording",[22],[34],{"name":35,"role":36,"phone":37,"phoneExt":13,"email":38},"Study Coordinator","CONTACT","763-807-1858","epilepsy@umn.edu",[40],{"facility":41,"status":13,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"University of Minnisota","Minneapolis","Minnesota","55414","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-93.26384,44.97997,{"lat":51,"lon":50},[54],{"name":55,"role":36,"phone":56,"phoneExt":13,"email":57},"Lindsey Study Coordinator","8582498702","ljardine@adraxe.com",{"type":59,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","100656169","early-phase-1-translational-recording-and-characterization-of-epilepsy-signals-using-subgaleal-eeg-during-standard-of-care-seeg-monitoring-100656169",false,"NCT07821697","Translational Recording and Characterization of Epilepsy Signals Using Subgaleal EEG During Standard-of-care SEEG Monitoring","TRCE","Inclusion Criteria:\n\n* Adults aged 18 years or older.\n* Diagnosis of drug-resistant epilepsy.\n* Scheduled to undergo clinically indicated inpatient standard-of-care stereoelectroencephalography (SEEG) monitoring.\n* Able and willing to provide written informed consent.\n* In the investigator's judgment, able to comply with study procedures.\n\nExclusion Criteria:\n\n* Any medical, neurological, psychiatric, or social condition that, in the investigator's judgment, would make participation unsafe or interfere with study procedures or data interpretation.\n* Active infection, skin condition, or other finding at the planned subgaleal electrode placement site that could increase procedural risk.\n* Known bleeding disorder, clinically significant coagulopathy, or use of anticoagulant\u002Fantiplatelet therapy that cannot be managed per institutional requirements for the planned procedure.\n* Pregnancy or breastfeeding.\n* Participation in another investigational study that, in the investigator's judgment, could interfere with TRACE procedures or outcomes.","ALL","18 Years",{"count":70,"type":71},15,"ESTIMATED","INTERVENTIONAL",[74],"EARLY_PHASE1","TRACE is a record-only study evaluating subgaleal EEG (sgEEG) recorded concurrently with standard-of-care stereoelectroencephalography (SEEG) in adults with drug-resistant epilepsy undergoing inpatient epilepsy monitoring. The study will assess the ability of sgEEG to detect seizures and characterize seizure timing, signal quality and stability, and lateralization compared with SEEG.",[77],"Epilepsy (Treatment Refractory)","NOT_YET_RECRUITING","2026-09-10",{"date":81,"type":82},"2026-09-16","ACTUAL",{"date":84,"type":71},"2026-10-15",{"date":86,"type":71},"2027-12-31",{"name":5,"class":6},1]