Actively Recruiting
Diffusion MRI Methods to Minimize Postoperative Deficits in Pediatric Epilepsy Surgery
Led by Wayne State University · Updated on 2024-07-23
60
Participants Needed
1
Research Sites
256 weeks
Total Duration
On this page
Sponsors
W
Wayne State University
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Diffusion MRI Methods to Minimize Postoperative Deficits in Pediatric Epilepsy Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects with drug-resistant focal epilepsy aged 3 to 19 years
- Planned two-stage epilepsy surgery with subdural electrodes
- Healthy control subjects aged 5 to 19 years
- Healthy controls have no cognitive, motor, or language impairments or behavioral problems
- Healthy controls have normal brain MRI results
You will not qualify if you...
- History of prematurity or perinatal hypoxic-ischemic event
- Hemiplegia found in preoperative neurological exam
- Dysmorphic features suggesting a clinical syndrome
- Diagnosis of developmental or psychiatric conditions predating seizures, including autism spectrum disorder, tic disorders, or obsessive-compulsive disorder
- MRI shows massive brain malformation or extensive lesions affecting brain tract accuracy
- History of claustrophobia
- Unsuccessful MRI due to head motion greater than 2 mm in DWMRI
- Participant cannot speak English
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Wayne State University/Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
Actively Recruiting
Research Team
J
Justin J Jeong, PhD
CONTACT
E
Eishi Asano, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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