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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
40
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.
Total volume of tract damage
Tract damage
Time frame: Assessed between pre and post-operative visits (6 month follow-up).
Resection Zone
Identification of resected region
Time frame: Assessed at surgical visit
Post-operative visual field testing
Outcome will be measured using a routine visual field testing procedure known as the Humphrey and Estermann perimetry test.
Time frame: Assessed at post-operative visit (6 month follow-up)
Total neurological planning time
Measured in hours
Time frame: Assessed during planning phase of surgery, between both pre and post-operative visits (6 month follow-up).
Total OR time
Measured in hours
Time frame: Assessed during surgical visit
Duration of hospital stay
Measured in # of days
Time frame: Assessed during surgical visit up to 26 weeks.
Number of seizure free days
Measured in # of days
Time frame: Assessed between surgical date until post-operative visit (6 month follow-up).
Total cost of surgery
Time frame: Assessed through study completion, an average of 1 year.
Quality of life assessment
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Measured using a standard epilepsy questionnaire known as the WHOQOL-BREF questionnaire (World Health Organization Quality of Life Assessment (WHOQOL-BREF))
Time frame: Assessed during surgical visit up to 26 weeks.
Functional impairment
Measured using a routine functional impairment test known as the Karnofsky performance scale
Time frame: Assessed during surgical visit up to 26 weeks.
Morbidity and complications
Number of cases
Time frame: Assessed through study completion, an average of 1 year.
Seizure control after surgery
Assessed using a routine seizure control test known as the Engel score, assessed by a neurologist/epileptologist
Time frame: Assessed at surgical visit up to 26 weeks.