Health TrialsbyHealthPanel

Diffusion MRI Methods to Minimize Postoperative Deficits in Pediatric Epilepsy Surgery

ConditionFocal Epilepsy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-19
SponsorWayne State University

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

Subjects with drug-resistant focal epilepsy

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.

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Patients with drug-resistant epilepsyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Accuracy of DCNN tract classification for detection of ESM-defined eloquent white matter pathways in healthy controls

Spatial overlap of DCNN tract classification (range: 0-100%, 0 indicating no overlap and 100% indicating complete overlap) will be evaluated between two different DWMRI scans of healthy controls: single-shell and generalized Q-sampling imaging (GQI) that are acquired on the same day. 14 ESM-defined eloquent pathways will be obtained using 14 DCNN tract classifications from the single-shell and GQI data, and the spatial overlap between single shell and GQI data (score: %) will be assessed per each pathway.

Time frame
During procedure
2

Accuracy of DCNN tract classification for detection of ESM-defined eloquent area that will be acquired a month after the DCNN tract classification in children with drug-resistant epilepsy

Spatial overlap (range: 0-100%, 0 indicating no overlap and 100% indicating complete overlap) will be measured between cortical terminals of DCNN-classified white matter pathways and their ground truth data: ESM-defined eloquent areas that will be acquired a month after the DCNN tract classification.

Time frame
1 month
3

Accuracy of DCNN tract classification for prediction of eloquent white matter pathways providing no postoperative deficits that will be assessed at 1.5 years after surgery

Preservation (score: 1) vs. no preservation (score: 0) of preoperative DCNN-classified white matter pathways will be compared with presence (score: 1) vs. absence (score: 0) of postoperative deficits in primary motor, language, auditory, and visual functions that will be assessed at 1.5 years after surgery.

Time frame
1.5 years
4

Accuracy of DCNN tract classification combined with Kalman analysis to predict optimal margin balancing maximal seizure freedom and minimal functional deficits that will be assessed at 1.5 years after surgery

Preservation (score: 1) vs. no preservation (score: 0) of preoperative DCNN-Kalman filter predicted surgical margin will be compared with presence (score: 1) vs. absence (score: 0) of postoperative deficits and seizure freedom that will be assessed at 1.5 years after surgery.

Time frame
1.5 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wayne State University

Lead sponsor

National Institutes of Health (NIH)

Collaborator

Source ClinicalTrials.gov
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