Diffusion MRI Methods to Minimize Postoperative Deficits in Pediatric Epilepsy Surgery

Launched by WAYNE STATE UNIVERSITY · Jul 22, 2021

Keywords

ClinConnect Summary

This clinical trial is exploring a new type of brain imaging called diffusion-weighted magnetic resonance imaging (DWMRI) to help guide surgery for children and teenagers with focal epilepsy that doesn't respond to medications. The main goal is to improve the safety and effectiveness of surgery by accurately locating important brain pathways that could be affected during the procedure. This innovative imaging method can be done quickly, in about 10 minutes, without needing any contrast dye or sedation, making it easier for young patients.

To participate in this study, children aged 3 to 19 with drug-resistant focal epilepsy who are scheduled for a specific type of epilepsy surgery can enroll. Healthy children aged 5 to 19 can also join as a comparison group, provided they do not have any neurological issues. Throughout the trial, participants will undergo advanced MRI scans and cognitive evaluations to understand how this new imaging approach might help reduce risks of cognitive deficits after surgery. It's important to note that the results of this study won't lead to immediate changes in treatment or clinical care until the methods are thoroughly validated.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subjects with drug-resistant focal epilepsy
• • 1. Age 3-19 years. 2. Planned two-stage epilepsy surgery with subdural electrodes.
• • 2. 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.
• Exclusion Criteria:
• For all subjects:
• • 1. History of prematurity or perinatal hypoxic-ischemic event. 2. Hemiplegia on preoperative neurological examination by pediatric neurologists. 3. Dysmorphic features suggestive of a clinical syndrome. 4. Diagnosis of any pervasive developmental or psychiatric condition which clearly predates the onset of seizures, including autism spectrum disorder, tic disorders, obsessive-compulsive disorder. 5. MRI abnormalities showing massive brain malformation and other extensive lesions that likely destroyed the contralateral tracts and severely affected i) spatial normalization accuracy in advanced normalization tools (ANTs), mutual information (MI) between native T1- MRI of Geodesic SyN transform and template T1-MRI \< mean-3\*standard deviation of MI in the healthy control group and ii) parcellation accuracy in surface-matching-based deformable registration, target registration error (TRE) of fine tetrahedra mesh between native T1- MRI brain surface and template T1-MRI brain surface \> mean-3\*standard deviation of TRE in the healthy control group. 6. History of claustrophobia. 7. Unsuccessful MRI showing head motion \> 2 mm in DWMRI (i.e., voxel size of DWMRI) which is evaluated by NIH TORTOISE DWMRI motion artifact correction package. 8. Subject who cannot speak English.