[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100593733":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":32,"locations":37,"responsibleParty":62,"collaborators":24,"id":64,"slug":24,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":24,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":24,"overallStatus":83,"whyStopped":24,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"The Hospital for Sick Children","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"VNS Treatment","ACTIVE_COMPARATOR","Patients in the VNS treatment arm will undergo surgical VNS implantation.",[13],"Device: VNS arm",{"label":15,"type":10,"description":16,"interventionNames":17},"DBS Treatment","Patients in the DBS treatment arm will undergo surgical DBS implantation.",[18],"Device: DBS Arm",[20,25],{"type":21,"name":22,"description":16,"armGroupLabels":23,"otherNames":24},"DEVICE","DBS Arm",[15],null,{"type":21,"name":26,"description":11,"armGroupLabels":27,"otherNames":24},"VNS arm",[9],[29],{"name":30,"affiliation":5,"role":31},"George M Ibrahim, MD, PhD","PRINCIPAL_INVESTIGATOR",[33],{"name":30,"role":34,"phone":35,"phoneExt":24,"email":36},"CONTACT","416-813-6125","george.ibrahim@sickkids.ca",[38],{"facility":5,"status":24,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Toronto","Ontario","M5G1X8","Canada","CA",{"type":45,"coordinates":46},"Point",[47,48],-79.39864,43.70643,{"lat":48,"lon":47},[51,56,60],{"name":52,"role":34,"phone":53,"phoneExt":54,"email":55},"MyLoi Huynh","416-813-7654","309117","myloi.huynh@sickkids.ca",{"name":57,"role":34,"phone":53,"phoneExt":58,"email":59},"Fay Kisteroff","309014","fay.kisteroff@sickkids.ca",{"name":61,"role":31,"phone":24,"phoneExt":24,"email":24},"George Ibrahim",{"type":31,"investigatorFullName":61,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Staff Neurosurgeon","100593733",false,"NCT07010276","Deep Brain Stimulation vs. Vagus Nerve Stimulation for Epileptic Spasms","Centromedian Deep Brain Stimulation vs. Vagus Nerve Stimulation for the Treatment of Drug-Resistant Epilepsy and Epileptic Spasms in Children: A Randomized Trial","DBS-VNS-ES","Inclusion Criteria:\n\n* Female or Male patients 5 years of age and over (17 and 11 months), not including 18 years old\n* Diagnosis of drug-resistant epilepsy with failure after trial of two anti-epileptic\n* Medications (as defined by Kwan et al. 20093). All children screened for entry into the study will be re-diagnosed by a neurologist prior to entry.\n* Main seizure type includes epileptic spasms and tonic spasms, as confirmed by electroencephalography.\n* Parents or legal guardians, including caregivers, are informed and able to give written consent.\n* Ability to comply with all testing, follow-ups and study appointments and protocols for 12 months following the end of the duration of the study\n\nExclusion Criteria:\n\n* Substance dependence or abuse in the last 6 months, excluding caffeine and nicotine\n* Any contraindication to MRI scanning. A preoperative MRI scan is essential to\n* Planning DBS and therefore any contraindication to MRI is a contraindication to enrollment in the study.\n* Unwillingness or inability to return to SickKids for follow-up visits.\n* Presence of cardiac arrhythmias, or other cardiac, respiratory, renal or endocrine conditions that will result in significant risk from a surgical procedure.\n* Pregnancy\n* Inability to communicate adequately in English in order to complete the baseline and follow-up questionnaires.\n* A co-morbid condition that requires frequent MRI scanning as part of the patient's regular care.","ALL","5 Years","17 Years",{"count":75,"type":76},20,"ESTIMATED","INTERVENTIONAL",[79],"NA","Deep Brain Stimulation vs. Vagus Nerve Stimulation for the Treatment of Drug-Resistant Epilepsy and Epileptic Spasms in Children: A Randomized Control Trial",[82],"Epilepsy; Seizure","NOT_YET_RECRUITING","2025-06-09",{"date":86,"type":87},"2025-06-12","ACTUAL",{"date":89,"type":76},"2025-11-24",{"date":91,"type":76},"2027-12-31",{"name":5,"class":6},1]