[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT02846272":3,"trial-entities:NCT02846272":81,"trial-summary:NCT02846272":85},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":34,"secondary_outcomes":38,"sex":39,"minimum_age":40,"maximum_age":41,"healthy_volunteers":14,"eligibility_criteria":42,"std_ages":48,"locations":51,"central_contacts":71,"overall_officials":75,"references":79,"see_also_links":80},"NCT02846272","HSC-MS-15-0022","Diffusion Tensor and Functional Connectivity Imaging in Pediatric Epilepsy: Imaging\u002FHistology Correlation","RECRUITING","2031-01-01","2024-12","2024-12-11","2015-11","The University of Texas Health Science Center, Houston","OTHER",false,"To determine the utility of diffusion tensor magnetic resonance imaging in the preoperative workup of children with intractable epilepsy referred for surgery.","To determine if diffusion tensor and functional connectivity magnetic resonance imaging helpful to better understand and diagnose intractable epilepsy in children. All enrolled children will undergo standard preoperative and postoperative MRI imaging, plus a 15 minute set of functional connectivity and diffusion tensor sequence with no additional sedation. This imaging data will be stripped of identifiers and be processed to provide both quantitative analysis, resting state functional connectivity changes and three dimensional modeling of white matter tracts adjacent to epileptogenic foci. This study is being done to determine if diffusion tensor and functional connectivity magnetic resonance imaging are helpful to better understand and diagnose intractable epilepsy in children.",[18],"Intractable Epilepsy",[],"INTERVENTIONAL","DIAGNOSTIC",[23],"NA",{"count":25,"type":26},50,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32},"PROCEDURE","Observation","Observation of MRI changes in subjects",[33],"Observational cohort",[35],{"measure":36,"timeFrame":37},"Number of participants with seizure outcome as determined by Engel","5 years",[],"ALL","0 Days","18 Years",{"inclusion":43,"exclusion":45,"raw_text":47},[44],"Children diagnosis with Intractable Epilepsy",[46],"No Intractable Epilepsy","Inclusion Criteria:\n\n* Children diagnosis with Intractable Epilepsy\n\nExclusion Criteria:\n\n* No Intractable Epilepsy",[49,50],"CHILD","ADULT",[52],{"facility":53,"status":7,"city":54,"state":55,"zip":56,"country":57,"contacts":58,"geoPoint":68},"UTHealth & Children's Memorial Hermann Hospital","Houston","Texas","77030","United States",[59,64],{"name":60,"role":61,"phone":62,"email":63},"Manish N Shah, M.D.","CONTACT","713-500-7410","Manish.N.Shah@uth.tmc.edu",{"name":65,"role":61,"phone":66,"email":67},"Bangning L Yu, R.N., PhD","713 500-7363","Bangning.Yu@uth.tmc.edu",{"lat":69,"lon":70},29.76328,-95.36327,[72,74],{"name":60,"role":61,"phone":73,"email":63},"713 500-7410",{"name":65,"role":61,"phone":66,"email":67},[76],{"name":60,"affiliation":77,"role":78},"UTHealth Medical School","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":82,"biomarkers":84},[83],"Seizure Disorder",[],{"nct_id":4,"found":86,"summary":87,"prompt_version":97},true,{"design":88,"status":89,"heading":90,"summary":91,"follow_up":92,"word_count":93,"commitments":94,"compensation":95,"drugs_mentioned":96},"This is an interventional study planning to enroll 50 participants. It is not specified if it is randomized or blinded.","completed","Imaging for Children with Intractable Epilepsy","This study is looking at how two special types of MRI scans, diffusion tensor imaging and functional connectivity imaging, can help doctors better understand and diagnose intractable epilepsy (seizures that are hard to control with medicine) in children. The study will observe changes in these MRI scans. Children from birth to 18 years old who have been diagnosed with intractable epilepsy can join. The main goal is to see how well these imaging techniques predict seizure outcomes five years after surgery. The current recruitment status is unclear.","Participants will be followed for five years to assess seizure outcomes.",87,"Participants will undergo standard MRI scans before and after surgery, plus a 15-minute functional connectivity and diffusion tensor sequence without extra sedation.","Not stated in the trial record.",[],"v2"]