Using advanced MRI to improve outcomes in pediatric epilepsy surgery

Novel DWI Methods to Minimize Postoperative Deficits in Pediatric Epilepsy Surgery

This study is testing a new type of MRI to help doctors plan safer and more effective surgery for children with epilepsy who don't respond to medication.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 3 Years to 19 Years
• Sex: All
• Sponsor: Wayne State University (Academic / other)
• Locations: 1 site (Detroit, Michigan)
• Trial ID: NCT04986683 on ClinicalTrials.gov

What this trial studies

This project aims to evaluate a novel diffusion-weighted magnetic resonance imaging (DWMRI) technique combined with a deep convolutional neural network (DCNN) to enhance the precision of surgical planning for children with drug-resistant focal epilepsy. By accurately identifying eloquent white matter pathways, the study seeks to minimize the risk of postoperative deficits while maximizing the chances of achieving seizure freedom. The DWMRI scans will be performed preoperatively without the need for contrast or sedation, making it a child-friendly approach. The study will also assess how this advanced imaging can reveal signs of brain reorganization that may influence surgical outcomes.

Who should consider this trial

Good fit: Ideal candidates include children and adolescents aged 3-19 years with drug-resistant focal epilepsy who are scheduled for two-stage epilepsy surgery.

Not a fit: Patients with significant brain abnormalities or those with developmental or psychiatric conditions that predate their seizures may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve surgical outcomes for pediatric epilepsy patients by reducing the risk of functional deficits and increasing the likelihood of seizure freedom.

How similar studies have performed: Other studies have shown promise with advanced imaging techniques in surgical planning, but this specific approach using DWMRI and DCNN is relatively novel.

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.

Where this trial is running

Detroit, Michigan

• Wayne State University/Children's Hospital of Michigan — Detroit, Michigan, United States (Recruiting)

Study contacts

• Study coordinator: Justin J Jeong, PhD

Conditions Focal Epilepsy