Temporal Lobe Epilepsy
Conditions
Brief summary
Using Synaptive Medical's BrightMatter™ products to better visualize and plan epilepsy surgeries by considering white matter tracts, and considering whether the technology results in improved clinical outcomes.
Detailed description
A common goal of focal brain resection is the removal of a lesion while preserving healthy eloquent tissues of the brain. One such eloquent area that is commonly aimed to be preserved are the white matter nerve fiber tracts which is critical of brain communication and function. This study aims to investigate whether the use of Synaptive Medical's BrightMatterTM technology can help neurosurgeons to better visualize and plan surgeries by considering the white matter tracts, and whether it results in improved clinical outcomes. This study will investigate the preservation of the optic radiations in anterior temporal lobectomy epilepsy surgeries.
Interventions
DEVICEBrightMatter™ products
BrightMatter™ Plan (BMP): BMP is a software that enables surgeons to plan their neurosurgery preoperatively. BMP automatically generates whole brain tractography and highly accurate fusion of anatomical MRI and DTI images. BrightMatter™ Bridge (BMB):BMB involves offering SMI's MRI expertise to ensure a smooth workflow in neuroimaging including DTI to ensure optimized protocols are used to acquire the DTI images. Once the images are acquired, they are evaluated for their quality in real time using a quality control (QC) algorithm. The QC allows quality assessment of DTI images at the time-of-scan allowing for immediate correction while the patient is still there and reduces the need for patient re-scan. BrightMatter™ Guide (BMG): BMG is a neuro-navigation system that utilizes the DTI information and the trajectory planned by the surgeon in BMP pre-operatively, but bringing it into the operating room intraoperatively.
Sponsors
University of Western Ontario, Canada
Synaptive Medical
Andrew Parrent
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total volume of tract damage | Assessed between pre and post-operative visits (6 month follow-up). | Tract damage |
| Resection Zone | Assessed at surgical visit | Identification of resected region |
| Post-operative visual field testing | Assessed at post-operative visit (6 month follow-up) | Outcome will be measured using a routine visual field testing procedure known as the Humphrey and Estermann perimetry test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of seizure free days | Assessed between surgical date until post-operative visit (6 month follow-up). | Measured in # of days |
| Total cost of surgery | Assessed through study completion, an average of 1 year. | — |
| Quality of life assessment | Assessed during surgical visit up to 26 weeks. | Measured using a standard epilepsy questionnaire known as the WHOQOL-BREF questionnaire (World Health Organization Quality of Life Assessment (WHOQOL-BREF)) |
| Total neurological planning time | Assessed during planning phase of surgery, between both pre and post-operative visits (6 month follow-up). | Measured in hours |
| Morbidity and complications | Assessed through study completion, an average of 1 year. | Number of cases |
| Seizure control after surgery | Assessed at surgical visit up to 26 weeks. | Assessed using a routine seizure control test known as the Engel score, assessed by a neurologist/epileptologist |
| Functional impairment | Assessed during surgical visit up to 26 weeks. | Measured using a routine functional impairment test known as the Karnofsky performance scale |
| Total OR time | Assessed during surgical visit | Measured in hours |
| Duration of hospital stay | Assessed during surgical visit up to 26 weeks. | Measured in # of days |
Contacts
Primary ContactAndrew Parrent
Backup ContactAli Khan
Outcome results
None listed