Actively Recruiting

Phase Not Applicable
Age: 3Years - 19Years
All Genders
Healthy Volunteers
NCT04986683

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

Age: 3Years - 19Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Wayne State University/Children's Hospital of Michigan

Detroit, Michigan, United States, 48201

Actively Recruiting

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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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