Novel DWI Methods to Minimize Postoperative Deficits in Pediatric Epilepsy Surgery

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 19
Healthy Volunteers: t
View:

• Subjects with drug-resistant focal epilepsy

• 1\. Age 3-19 years. 2. Planned two-stage epilepsy surgery with subdural electrodes.

• 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.

Locations
United States
Michigan
Wayne State University/Children's Hospital of Michigan
RECRUITING
Detroit
Contact Information
Primary
Justin J Jeong, PhD
jjeong@med.wayne.edu
313-993-0258
Backup
Eishi Asano, MD, PhD
easano@med.wayne.edu
313-745-5547
Time Frame
Start Date: 2021-08-01
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 60
Treatments
Experimental: Patients with drug-resistant epilepsy
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.
Related Therapeutic Areas
Sponsors
Leads: Wayne State University
Collaborators: National Institutes of Health (NIH)

This content was sourced from clinicaltrials.gov