NCT04986683 Diffusion MRI Methods to Minimize Postoperative Deficits in Pediatric Epilepsy Surgery
| NCT ID | NCT04986683 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Wayne State University |
| Condition | Focal Epilepsy |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2021-08-01 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2021-08-01 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Subjects with drug-resistant focal epilepsy 1\. Age 3-19 years. 2. Planned two-stage epilepsy surgery with subdural electrodes. 2. Healthy control subjects 1. Age 5-19 years. 2. No cognitive, motor, and/or language impairment or clinical elevations on a measure of behavioral problems. 3. Brain MRI interpreted as normal. Exclusion Criteria: For all subjects: 1\. 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 \< 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04986683 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 19 Years, studying Focal Epilepsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04986683 currently recruiting?
Yes, NCT04986683 is actively recruiting participants. Contact the research team at jjeong@med.wayne.edu for enrollment information.
Where is the NCT04986683 trial being conducted?
This trial is being conducted at Detroit, United States.
Who is sponsoring the NCT04986683 clinical trial?
NCT04986683 is sponsored by Wayne State University. The trial plans to enroll 60 participants.
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