[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100499557":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":30,"responsibleParty":45,"collaborators":47,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":20,"eligibilityCriteria":56,"healthyVolunteers":53,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":20,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":20,"overallStatus":33,"whyStopped":20,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"Yale University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Participants with ongoing non-convulsive or focal motor SE","EXPERIMENTAL","Adult patients with ongoing non-convulsive or focal motor SE despite treatment with at least 2 ASMs and who are monitored with surface EEG will be screened and enrolled to receive up to 2 sessions of PLIFU.",[13],"Device: PLIFU",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","PLIFU","Participants will be treated with up to 2 sessions of PLIFU (on the same day), while monitored with surface EEG and will be observed for the remainder of the hospital stay as deemed by the primary care team. The system non-invasively delivers ultrasound sonications intracranially that selectively target specific areas of the brain.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Imran Quraishi, MD","PRINCIPAL_INVESTIGATOR",[26],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},"CONTACT","(203) 785-3865","imran.quraishi@yale.edu",[31],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":20},"Yale New Haven Hospital","RECRUITING","New Haven","Connecticut","06520","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-72.92816,41.30815,{"lat":43,"lon":42},{"type":46,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[48],{"name":49,"class":50},"Swebilius Foundation","UNKNOWN","100499557","acute-effects-of-focused-ultrasound-modulation-on-eeg-behavior-in-status-epilepticus-patients-100499557",false,"NCT05784805","Acute Effects of Focused Ultrasound Modulation on EEG Behavior in Status Epilepticus Patients","Inclusion Criteria:\n\n* Subjects diagnosed with ongoing NCSE or FMSE despite treatment with at least 2 ASMs\n* Provision of signed and dated informed consent form obtained from the next-of-kin\u002Flegally authorized representative\n* Treated in the ICU while monitored with continuous scalp EEG electrodes\n\nExclusion Criteria:\n\n* Unable to obtain informed consent\n* Presence of an implanted cranial neuromodulation device for treatment of epilepsy\n* Pregnancy\n* Treatment with another investigational drug or other intervention within 24 hr\n* Presence of burr hole(s) or craniotomy\n* Subjects with ferromagnetic materials in the head\n* Subjects with a TENS unit","ALL","19 Years","85 Years",{"count":61,"type":62},10,"ESTIMATED","INTERVENTIONAL",[65],"NA","In this study, the investigators propose Pulsed Low-Intensity Focused Ultrasound (PLIFU) stimulation of brain regions that modulate (thalamus) or generate focal motor seizures (primary motor cortex), with the goal of ameliorating seizure activity in subjects in non-convulsive or focal motor status epilepticus. The course of treatment will consist of an initial 10 minute PLIFU treatment session with an option for a 2nd session if necessary.\n\nThe primary objective of this study is to determine whether PLIFU reduces or suppresses epileptic activity in patients with Non-Convulsive Status Epilepticus (NCSE)\u002FFocal Motor Status Epilepticus (FMSE) that have not responded to standard of care.",[68],"Seizures","2025-10-27",{"date":71,"type":72},"2025-10-29","ACTUAL",{"date":74,"type":72},"2023-06-24",{"date":76,"type":62},"2026-02",{"name":5,"class":6},1]