[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585113":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":31,"responsibleParty":64,"collaborators":68,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":20,"eligibilityCriteria":82,"healthyVolunteers":78,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":20,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":94,"overallStatus":99,"whyStopped":20,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Mayo Clinic","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Epilepsy","EXPERIMENTAL","Patients with drug resistant epilepsy undergoing a surgical evaluation in the epilepsy monitoring unit",[13],"Device: Brain Interchange System",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Brain Interchange System","The CorTec Brain Interchange (BIC) is an implantable system with sensing and stimulation capability dedicated to promoting brain computer interface and closed-loop neuromodulation research. It is an externally powered implant which can provide neural data to a nearby computing station (communication unit connected to a personal computer) continuously. In return, computing station controls the implant e.g. for generating therapeutic electrical stimulation to the brain. It is expected that BIC will catalyze translational applications of electroceuticals in human subject by making the neural data immediately available as well as permit the investigation of novel closed-loop neuromodulation applications.",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Nuri F Ince, Ph.D.","CONTACT","5072843134","Ince.Nuri@mayo.edu",{"name":28,"role":24,"phone":29,"phoneExt":20,"email":30},"Gregory A Worrell, M.D., Ph.D.","5072847085","Worrell.Gregory@mayo.edu",[32,49],{"facility":5,"status":20,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Rochester","Minnesota","55905","United States","US",{"type":39,"coordinates":40},"Point",[41,42],-92.4699,44.02163,{"lat":42,"lon":41},[45],{"name":46,"role":24,"phone":47,"phoneExt":20,"email":48},"Chandra Prakash Swamy, M.S.","507-255-1516","Swamy.ChandraPrakash@mayo.edu",{"facility":50,"status":20,"city":51,"state":52,"zip":53,"country":36,"countryCode":37,"cosmosGeoPoint":54,"geoPoint":58,"contacts":59},"Baylor College of Medicine","Houston","Texas","77030-3498",{"type":39,"coordinates":55},[56,57],-95.36327,29.76328,{"lat":57,"lon":56},[60],{"name":61,"role":24,"phone":62,"phoneExt":20,"email":63},"Alica Goldman, M.D., Ph.D.","713-798-0980","agoldman@bcm.edu",{"type":65,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Nuri F. Ince","Principal Investigator",[69,72,73],{"name":70,"class":71},"National Institute of Neurological Disorders and Stroke (NINDS)","NIH",{"name":50,"class":6},{"name":74,"class":75},"CorTec GmbH","UNKNOWN","100585113","acute-stimulation-and-modulation-of-stereotyped-high-frequency-oscillations-100585113",false,"NCT06898138","Acute Stimulation and Modulation of Stereotyped High-Frequency Oscillations","Acute Stimulation for the Modulation of Epileptic Events With a Closed-Loop Brain Interchange System in Drug Resistant Epilepsy","Inclusion Criteria:\n\n* Patients with medically refractory epilepsy, who have been deemed appropriate candidates for intracranial EEG monitoring\n* Adult men and women (18≤ age \\\u003C70 years)\n* Children (3≤ age \\\u003C18 years)\n* Includes women and minorities\n\nExclusion Criteria:\n\n• Subjects will be excluded if their condition makes them unable to continue with recordings.","ALL","3 Years","70 Years",{"count":87,"type":88},8,"ESTIMATED","INTERVENTIONAL",[91],"NA","Overall, this study will investigate the functional utility of stereotyped HFOs by capturing them with a new implantable system (Brain Interchange - BIC of CorTec), which can sample neural data at higher rates \\>=1kHz and deliver targeted electrical stimulation to achieve seizure control. In contrast to current closed-loop systems (RNS), which wait for the seizure to start before delivering stimulation, the BIC system will monitor the spatial topography and rate of stereotyped HFOs and deliver targeted stimulation to these HFO generating areas to prevent seizures from occurring. If the outcomes of our research in an acute setting become successful, the investigators will execute a clinical trial and run the developed methods with the implantable BIC system in a chronic ambulatory setting.",[9],[95,96,9,97,98],"neuromodulation","HFO","Machine Learning","Closed-Loop","NOT_YET_RECRUITING","2026-08-07",{"date":102,"type":103},"2026-08-11","ACTUAL",{"date":105,"type":88},"2026-11-01",{"date":107,"type":88},"2029-08-31",{"name":5,"class":6},2]