[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100438238":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":31,"centralContacts":32,"locations":42,"responsibleParty":64,"collaborators":68,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":31,"eligibilityCriteria":78,"healthyVolunteers":79,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":31,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":31,"overallStatus":45,"whyStopped":31,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Wayne State University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients with drug-resistant epilepsy","EXPERIMENTAL","All patients who undergo two-stage epilepsy surgery will receive two longitudinal evaluations of brain MRI and neuropsychology test: a month before surgery and 1.5 years after surgery.",[13,14],"Diagnostic Test: Brain magnetic resonance imaging","Behavioral: Neuro-psychology testing",[16,23],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DIAGNOSTIC_TEST","Brain magnetic resonance imaging","Brain magnetic resonance imaging (MRI) will be done using multiple sequences to evaluate the presence, type, and severity of brain abnormalities in enrolled subjects.",[9],[22],"MRI",{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"BEHAVIORAL","Neuro-psychology testing","Participants will undergo age-appropriate neuro-psychology testing to assess motor, language, and other neurocognitive functions potentially affected by drug-resistant epilepsy.",[9],[29,30],"neuro-cognitive testing","neuro-psychology",null,[33,38],{"name":34,"role":35,"phone":36,"phoneExt":31,"email":37},"Justin J Jeong, PhD","CONTACT","313-993-0258","jjeong@med.wayne.edu",{"name":39,"role":35,"phone":40,"phoneExt":31,"email":41},"Eishi Asano, MD, PhD","313-745-5547","easano@med.wayne.edu",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Wayne State University\u002FChildren's Hospital of Michigan","RECRUITING","Detroit","Michigan","48201","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-83.04575,42.33143,{"lat":55,"lon":54},[58,62],{"name":59,"role":35,"phone":60,"phoneExt":31,"email":61},"Aimee Luat, MD","313-832-9620","aluat@dmc.org",{"name":63,"role":35,"phone":40,"phoneExt":31,"email":41},"Eishi Asano, MD, PHD",{"type":65,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"PRINCIPAL_INVESTIGATOR","Justin Jeong-Won Jeong","Associate Professor",[69],{"name":70,"class":71},"National Institutes of Health (NIH)","NIH","100438238","diffusion-mri-methods-to-minimize-postoperative-deficits-in-pediatric-epilepsy-surgery-100438238",false,"NCT04986683","Diffusion MRI Methods to Minimize Postoperative Deficits in Pediatric Epilepsy Surgery","Novel DWI Methods to Minimize Postoperative Deficits in Pediatric Epilepsy Surgery","Inclusion Criteria:\n\n1. Subjects with drug-resistant focal epilepsy\n\n   1\\. Age 3-19 years. 2. Planned two-stage epilepsy surgery with subdural electrodes.\n2. Healthy control subjects 1. Age 5-19 years. 2. No cognitive, motor, and\u002For language impairment or clinical elevations on a measure of behavioral problems. 3. Brain MRI interpreted as normal.\n\nExclusion Criteria:\n\nFor all subjects:\n\n1\\. History of prematurity or perinatal hypoxic-ischemic event. 2. Hemiplegia on preoperative neurological examination by pediatric neurologists. 3. Dysmorphic features suggestive of a clinical syndrome. 4. Diagnosis of any pervasive developmental or psychiatric condition which clearly predates the onset of seizures, including autism spectrum disorder, tic disorders, obsessive-compulsive disorder. 5. MRI abnormalities showing massive brain malformation and other extensive lesions that likely destroyed the contralateral tracts and severely affected i) spatial normalization accuracy in advanced normalization tools (ANTs), mutual information (MI) between native T1- MRI of Geodesic SyN transform and template T1-MRI \\\u003C mean-3\\*standard deviation of MI in the healthy control group and ii) parcellation accuracy in surface-matching-based deformable registration, target registration error (TRE) of fine tetrahedra mesh between native T1- MRI brain surface and template T1-MRI brain surface \\> mean-3\\*standard deviation of TRE in the healthy control group. 6. History of claustrophobia. 7. Unsuccessful MRI showing head motion \\> 2 mm in DWMRI (i.e., voxel size of DWMRI) which is evaluated by NIH TORTOISE DWMRI motion artifact correction package. 8. Subject who cannot speak English.",true,"ALL","3 Years","19 Years",{"count":84,"type":85},60,"ESTIMATED","INTERVENTIONAL",[88],"NA","This project will test the accuracy of a novel diffusion-weighted magnetic resonance imaging (DWMRI) approach using a deep convolutional neural network (DCNN) to predict an optimal resection margin for pediatric epilepsy surgery objectively. Its primary goal is to minimize surgical risk probability (i.e., functional deficit) and maximize surgical benefit probability (i.e., seizure freedom) by precisely localizing eloquent white matter pathways in children and adolescents with drug-resistant focal epilepsy. This new imaging approach, which will acquire a DWMRI scan before pediatric epilepsy surgery in about 10 minutes without contrast administration (and also without sedation even in young children), can be readily applied to improve preoperative benefit-risk evaluation for pediatric epilepsy surgery in the future. The investigators will also study how the advanced DWMRI-DCNN connectome approach can detect complex signs of brain neuronal reorganization that help improve neurological and cognitive outcomes following pediatric epilepsy surgery. This new imaging approach could benefit targeted interventions in the future to minimize neurocognitive deficits in affected children. All enrolled subjects will undergo advanced brain MRI and neurocognitive evaluation to achieve these goals. The findings of this project will not guide any clinical decision-making or clinical intervention until the studied approach is thoroughly validated.",[91],"Focal Epilepsy","2024-07-22",{"date":94,"type":95},"2024-07-23","ACTUAL",{"date":97,"type":95},"2021-08-01",{"date":99,"type":85},"2026-06-30",{"name":5,"class":6},1]