Application of Diffusion Tensor Imaging and Tractography in Epilepsy Surgery
Temporal Lobe Epilepsy
About this trial
This is an interventional diagnostic trial for Temporal Lobe Epilepsy
Eligibility Criteria
Inclusion Criteria:
- Patients diagnosed with temporal lobe epilepsy between 18 and 65 years of age.
- Patients whose seizures are disabling and/or are not controlled by any form of epileptic medication.
- Patients whose clinical pre-surgical investigations indicates the need for anterior temporal lobe resection (ATLR).
Exclusion Criteria:
- Prior resective epilepsy surgery.
- Past or planned non resective epilepsy surgery (such as a corpus callosotomy and vagal nerve stimulator placement).
- Contraindication to MRI, and/or whom are (or suspect to) being pregnant.
- Complicated medical problems such as cancer or heart disease.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
Control Group
Treatment Arm
Control Group (involvement of BrightMatter™ Plan (BMP)): Patients with temporal lobe epilepsy, who have been identified as candidates for anterior temporal lobe resection (ATLR) will be recruited. All epilepsy patients will have clinical MRI scans that include a diffusion tensor imaging (DTI) protocol. Surgery will be carried out according to usual standard of care, without the use of processing for DTI tractography. Additional clinical scanning with the same protocol will be carried out post-operatively at 6 months. Pre-operative and post-operative (6-month) visual field assessments (Estermann Perimetry and Humphrey Perimetry) will also be carried out . Primary outcomes will be assessed to identify the baseline incidence of visual of postoperative visual field deficits.
Treatment group (involvement of all three products BrightMatter™ Plan (BMP), BrightMatter™ Bridge (BMB), and BrightMatter™ Guide(BMG): A treatment group (prospective enrollment) that uses the interventional technology will be recruited based on the same eligibility criteria as control cohort. All epilepsy patients will have clinical MRI scans that include a DTI protocol. For this treatment group of patients, the BrightMatter system (BMB,BMP, and BMG) will be employed pre-operatively and intra-operatively for planning before and guidance during anterior temporal lobe resection (ATLR). Additional clinical scanning with the same protocol will be carried out post-operatively at 6 months. Pre-operative and post-operative (6-month) visual field assessments (Estermann Perimetry and Humphrey Perimetry) will also be carried out. Primary outcomes will be assessed to evaluate the effect of surgical planning and guidance with DTI tractography on outcomes, by comparison against the control cohort.