A Pilot Study to Evaluate MR-guided Laser Ablation of Focal Lesions in Patients With Medically Refractory Partial Epilepsy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 14
- 试验地点
- 4
- 主要终点
- The number of seizures recorded in seizure diary
研究概览
简要总结
To investigate whether MR-guided laser induced thermal therapy in patients diagnosed with focal lesional epilepsy using the Visualase Thermal Therapy System is both a feasible and safe minimally invasive technique for control of seizures in such patients.
详细描述
In this study, we propose to evaluate a novel, thermal therapy and feedback system (Visualase® Thermal Therapy System) as an alternative to surgical resection for the treatment of focal lesional epilepsy in patients that are considered high risk surgical candidates. This system includes the FDA-cleared Visualase Cooled Laser Applicator System (VCLAS), which allows delivery of laser energy while the patient is being imaged by an MRI unit. The Visualase® System works via real-time MR thermal imaging (MRTI) to provide information on the thermal dose delivered to the target, resulting in a more precise and controlled delivery which has heretofore not been possible with previous non-image guided laser technology. We hypothesize that the Visualase system can be used in patients refractory to medication therapy in a minimally invasive procedure to destroy epileptogenic focal lesions in the brain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older at entry to protocol.
- •History of MRI lesional-related epilepsy for at least one year.
- •Failure to respond to more than 2 anti-epileptic drugs at adequate dose and duration.
- •Candidate for resective epilepsy surgery.
- •Considered healthy enough to undergo surgery with general anesthesia.
- •The patient has given written informed consent after the nature of the study and alternative treatment options have been explained.
- •Must have 3 months of seizure frequency recorded prior to procedure.
排除标准
- •Presence of any non-MRI compatible implanted electronic device.
- •Presence of a metallic prosthetic or implant including artificial hips, knees, joints, or rods and screws.
- •Active Major depression
- •History of Suicide attempts
- •History of Non-Epileptic Behavioral Spells
结局指标
主要结局
The number of seizures recorded in seizure diary
时间窗: Baseline to 1 year
次要结局
未报告次要终点
研究者
W. Richard Marsh
Principle Investigator
Mayo Clinic