Diffusion MRI Methods to Minimize Postoperative Deficits in Pediatric Epilepsy Surgery

Part of paid clinical trials in Detroit, Michigan.

Sponsor
Wayne State University
Study ID
NCT04986683
Status
Recruiting
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Conditions

  • Focal Epilepsy

Eligibility Criteria

Sex
ALL
Age
3 Years - 19 Years
Healthy Volunteers
Accepted

Interventions

  • Brain magnetic resonance imaging — DIAGNOSTIC_TEST
    Brain magnetic resonance imaging (MRI) will be done using multiple sequences to evaluate the presence, type, and severity of brain abnormalities in enrolled subjects.
  • Neuro-psychology testing — BEHAVIORAL
    Participants will undergo age-appropriate neuro-psychology testing to assess motor, language, and other neurocognitive functions potentially affected by drug-resistant epilepsy.

Study Details

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.

Key Dates

Start date
Aug 1, 2021
Status verified
Jul 2024
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • 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.

Primary Outcome Measure

Accuracy of DCNN tract classification for detection of ESM-defined eloquent white matter pathways in healthy controls [ Time Frame: During procedure ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Wayne State University/Children's Hospital of MichiganDetroitMichigan48201
Aimee Luat, MD
[email protected]
313-832-9620
Eishi Asano, MD, PHD
[email protected]
313-745-5547

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By research site
Wayne State University/Children's Hospital of Michigan· Detroit, MI

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