Minimally Invasive Image-Guided Laser Treatment of Epilepsy

微创图像引导激光治疗癫痫

• 批准号: 8315512
• 负责人: Ashok Gowda
• 金额: $ 16.09万
• 依托单位: BIOTEX, INC.
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-06-01 至 2013-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8315512
• 关键词: 3-Dimensional; Ablation; Address; Adoption; Adult; Antiepileptic Agents; Area; Biopsy; Brain; Brain Neoplasms; Brain region; Cancerous; Child; Childhood; Clinical; Clinical Data; Clinical Research; Coagulation Process; Code; Computer Workstations; Computer software; Craniotomy; Development; Devices; Disease; Enrollment; Epilepsy; Evaluation; Excision; Family; Feasibility Studies; Freedom; Goals; Home environment; Hospitals; Hour; Image; Institutional Review Boards; Intervention; Intractable Epilepsy; Lasers; Lesion; Life; Low-Level Laser Therapy; Magnetic Resonance Imaging; Medical; Methodist Church; Methods; Monitor; Morbidity - disease rate; Multi-Institutional Clinical Trial; Nature; Neurologic; Operative Surgical Procedures; Patient Selection; Patients; Pattern; Pharmaceutical Preparations; Phase; Procedures; Process; Quality of life; Refractory; Regimen; Risk; Safety; Seizures; Shapes; Small Business Innovation Research Grant; Structure; Surveys; System; Techniques; Technology; Temperature; Temporal Lobe Epilepsy; Testing; Therapeutic; Thermal Ablation Therapy; Time; Tissues; United States National Institutes of Health; Universities; data registry; design; follow-up; health economics; improved; inclusion criteria; interstitial; minimally invasive; soft tissue; tumor

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.

描述（由申请人提供）：本SBIR I期申请的目标是开发一种用于致癫痫性癫痫发作病灶激光消融的新型微创疗法。对于美国近100万癫痫患者来说，目前的药物治疗难以满足更好的治疗选择的需求。虽然手术切除致痫灶在70%的精心选择的病例中提供了缓解，但由于手术的高度侵入性，大多数患者决定反对这种选择。我们假设，精确的，图像引导的激光热消融癫痫灶将提供接近手术切除的癫痫发作缓解方面的结果，并可以进行手术发病率的风险要低得多的病人。在第一阶段，我们将使用FDA批准的技术（Visualase热治疗系统），该技术目前用于癌症肿瘤消融应用，在药物治疗无效且具有可识别病变的成人癫痫患者中进行试点可行性研究。我们还将开发硬件和软件增强功能，以优化该应用程序的系统。在第二阶段，我们将对具有更广泛入选标准的患者进行扩展的多中心临床研究，包括内侧颞叶癫痫的治疗。最后，我们将构建一个数据登记系统，目的是收集设计成功的FDA III期试验所需的临床数据，我们将在III期试验中寻求癫痫治疗的特定适应症。 公共卫生相关性： 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来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。该项目将使用MRI引导的激光技术开发精确的方法，如果成功，有可能成为微创选择。