Clinical Trial

Diffusion MRI Methods to Minimize Postoperative Deficits in Pediatric Epilepsy Surgery

Unknown
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Record status
This record was last updated July 23, 2024 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 1 change
critical Trial status changed: Recruiting → Unknown 2026-08-02
Trial Details
NCT Number NCT04986683
Lead Sponsor Wayne State University
Collaborators: National Institutes of Health (NIH)
Conditions Focal Epilepsy
Enrollment 60 participants
Start Date 2021-08-01
Primary Completion 2026-06-30 (estimated)
Study Completion 2026-06-30 (estimated)
Updated on ClinicalTrials.gov 2024-07-23