Minimally Invasive Image-Guided Laser Treatment of Epilepsy

描述(由申请人提供)：这一阶段SBIR应用的目标是开发一种新的微创疗法，用于激光消融致痫灶。对于美国近100万癫痫患者来说，有大量尚未得到满足的更好的治疗选择，这些患者对目前的药物治疗很难接受。虽然手术切除癫痫灶可以缓解70%的精心挑选的病例，但由于手术的高度侵入性，大多数患者决定不接受这一选择。我们假设，精确的、图像引导的激光热消融治疗癫痫灶在缓解癫痫发作方面将提供接近手术切除的结果，并且对患者来说，手术并发症的风险要低得多。在第一阶段，我们将使用FDA批准的技术(Visualase热疗系统)，该技术目前用于癌症肿瘤消融应用，对药物治疗无效且有可识别病变导致癫痫发作的成年癫痫患者进行试验性可行性研究。我们还将开发硬件和软件增强功能，以针对这一应用程序优化系统。在第二阶段，我们将对具有更广泛纳入标准的患者进行扩大的多中心临床研究，包括内侧颞叶癫痫的治疗。最后，我们将建立一个数据注册表，目的是收集必要的临床数据，以设计成功的FDA第三阶段最终试验，在该试验中，我们将寻找治疗癫痫的具体适应症。 公共卫生相关性： 相关性目前的药物治疗使30%的癫痫患者无法充分控制癫痫发作。开发一种微创手术方案，以热破坏大脑中负责癫痫发作的组织，将对癫痫患者及其家人产生重大影响。该项目将利用MRI引导的激光技术开发精确的方法，如果成功，将有可能成为微创选择。

DESCRIPTION (provided by applicant): The goal of this Phase I SBIR application is to develop a new minimally invasive therapy for laser ablation of epileptogenic seizure foci. There is a large unmet need for better treatment options for the nearly one million epilepsy patients in the U.S. that are refractory to current medical treatments. While surgical removal of the epileptogenic foci offers relief in 70 percent of the well selected cases, most patients decide against this option due to the highly invasive nature of the procedure. We hypothesize that precise, image-guided laser thermal ablation of epilepsy foci would provide results approaching surgical resection in terms of seizure relief, and could be carried out with a far lower risk of surgical morbidity to the patient. In Phase I we will use our FDA-cleared technology (Visualase Thermal Therapy System), which is currently used for cancerous tumor ablation applications, to perform a pilot feasibility study in adult epilepsy patients who are refractory to medical therapy and have an identifiable lesion deemed responsible for their seizures. We will also develop hardware and software enhancements which will optimize the system for this application. In Phase II, we will perform expanded multi-center clinical studies on patients with broader inclusion criteria, including treatment of mesial temporal lobe epilepsies. Finally, we will construct a data registry with the goal of gathering clinical data necessary for the design of a successful definitive FDA trial in Phase III in which we will seek specific indications for the treatment of Epilepsy. PUBLIC HEALTH RELEVANCE: RELEVANCE Current medical therapy leaves 30 percent of Epilepsy patients without adequate control of their seizures. Development of a minimally invasive surgical option for thermally destroying the tissue in the brain responsible for seizures would have a significant impact on epilepsy patients and their families. This project will develop precise methods using MRI-guided laser technology, which if successful, has potential to be that minimally invasive option.