Actively Recruiting
Novel 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
N/A
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
Researchers are evaluating a new diffusion-weighted magnetic resonance imaging (DWMRI) approach combined with a deep convolutional neural network (DCNN) to improve planning for pediatric epilepsy surgery. The study focuses on children and adolescents aged 3 to 19 years with drug-resistant focal epilepsy and aims to precisely identify critical brain pathways to reduce surgical risks and improve seizure freedom. This advanced imaging technique may also reveal brain reorganization that supports better cognitive outcomes after surgery. Participants will have a DWMRI brain scan lasting about 10 minutes without the need for sedation or contrast, performed before epilepsy surgery. The study involves two main parts: first, testing the accuracy of the DCNN method compared to standard electrical stimulation mapping in locating important brain areas; and second, assessing whether this technique can predict long-term improvements in neurocognitive functions after surgery. Patients undergoing two-stage epilepsy surgery will receive MRI and neuropsychology evaluations before surgery and again 1.5 years after surgery. Throughout the study, participants will undergo advanced brain MRI scans and detailed neuropsychological testing to assess motor, language, and cognitive functions. Researchers will measure the accuracy of the imaging method in detecting crucial brain pathways and its ability to predict seizure control and avoid postoperative deficits over a follow-up period of 1.5 years. The study also examines brain network changes related to cognitive improvements. The findings will not guide clinical decisions until fully validated.
CONDITIONS
Brief 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 with no cognitive, motor, or language impairment
- Healthy controls with normal brain MRI
You will not qualify if you...
- History of prematurity or perinatal hypoxic-ischemic event
- Hemiplegia on preoperative neurological exam
- Dysmorphic features suggesting a clinical syndrome
- Diagnosis of pervasive developmental or psychiatric conditions predating seizures, including autism, tic disorders, obsessive-compulsive disorder
- MRI abnormalities showing massive brain malformation or extensive lesions affecting brain tract accuracy
- History of claustrophobia
- Unsuccessful MRI due to head motion over 2 mm in diffusion MRI
- Inability to speak English
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1 month before surgery
Participants undergo advanced brain magnetic resonance imaging (MRI) and age-appropriate neuro-psychology testing to evaluate brain abnormalities and assess motor, language, and other neurocognitive functions before surgery.
1 visit (in-person)
Duration - Surgery day and immediate recovery period
Participants undergo two-stage epilepsy surgery with subdural electrodes as part of their clinical care.
1 surgical procedure visit
Duration - Approximately 1.5 years after surgery
Participants have follow-up brain MRI and neuro-psychology testing approximately 1.5 years after surgery to assess long-term neurocognitive improvement and functional outcomes.
1 follow-up visit (in-person)
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
E
Eishi Asano, MD, PhD
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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