Application of Diffusion Tensor Imaging and Tractography in Epilepsy Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 主要终点
- Resection Zone
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
Control Group
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 Arm
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.
干预措施: BrightMatter™ products (Device)
结局指标
主要结局
Resection Zone
时间窗: Assessed at surgical visit
Identification of resected region
Total volume of tract damage
时间窗: Assessed between pre and post-operative visits (6 month follow-up).
Tract damage
Post-operative visual field testing
时间窗: 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.
次要结局
- Quality of life assessment(Assessed during surgical visit up to 26 weeks.)
- Total neurological planning time(Assessed during planning phase of surgery, between both pre and post-operative visits (6 month follow-up).)
- Total OR time(Assessed during surgical visit)
- 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.)
- Number of seizure free days(Assessed between surgical date until post-operative visit (6 month follow-up).)
- Functional impairment(Assessed during surgical visit up to 26 weeks.)
- Morbidity and complications(Assessed through study completion, an average of 1 year.)
- Seizure control after surgery(Assessed at surgical visit up to 26 weeks.)
研究者
Andrew Parrent
Neurosurgeon; Associate Professor
London Health Sciences Centre