Application of Diffusion Tensor Imaging and Tractography in Epilepsy Surgery
- Conditions
- Temporal Lobe Epilepsy
- Registration Number
- NCT02590419
- Lead Sponsor
- Andrew Parrent
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
- 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).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Resection Zone Assessed at surgical visit Identification of resected region
Total volume of tract damage Assessed between pre and post-operative visits (6 month follow-up). Tract damage
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 Outcome Measures
Name Time Method 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
Total OR time Assessed during surgical visit Measured in hours
Total cost of surgery Assessed through study completion, an average of 1 year. Duration of hospital stay Assessed during surgical visit up to 26 weeks. Measured in # of days
Number of seizure free days Assessed between surgical date until post-operative visit (6 month follow-up). Measured in # of days
Functional impairment Assessed during surgical visit up to 26 weeks. Measured using a routine functional impairment test known as the Karnofsky performance scale
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