Wireless ECoG Recording for Epilepsy Monitoring

描述（由申请人提供）：致痫灶的手术切除是一种常见的治疗方法，通常对因其他难治性癫痫引起的衰弱性癫痫发作患者有益。该手术的成功取决于医疗团队精确定位患者大脑中致痫区的能力，以及确定切除过程中必须避免的重要皮质区域的能力。公认的定位致痫区的最佳方法是用硬膜下电极长期植入记录癫痫发作活动，最长可达7天。在监测期间，电极通过电缆连接到外部记录设备。这种侵入性手术有以下缺点：（a）需要长期和昂贵的住院时间。(b)长时间的预防增加了严重和潜在致命感染的可能性。(c)一名家庭成员或保姆必须随时与病人在一起。(d)躺在床上，被无数的电缆拴在墙上，使一些病人难以科普。(e)如果电缆被意外牵拉并且网格移动，则存在脑内出血的风险。(f)10%到20%的患者在住院期间没有足够的癫痫发作来确定癫痫区。我们 建议开发将避免这些缺点的无线硬膜下电极。无线电极将允许用于手术放置的开颅术完全闭合，并且将避免使用将电极连接到数据处理硬件的经颅多线电缆。关闭硬脑膜和颅骨的能力，避免了通向大脑的有线管道，将降低由于感染引起的发病风险，并通过允许患者在大部分监测阶段离开医院来降低成本。无线门诊监测的一个潜在的显著好处是能够提供更长的监测期，长达29天，这允许在患者接受完整的抗癫痫药物治疗方案时记录习惯性癫痫发作活动。基于习惯性癫痫发作活动的定位将改善切除手术的结果，并扩大手术是一种选择的患者人群。第II阶段的目标是通过与临床硬连线硬膜下网格和记录系统的并行比较，确定无线器械在犬体内植入29天后的诊断能力和安全性，作为评估的基础。程序成功定义为实现与传统网格临床等效的癫痫发作定位数据和等效或减少的病理。这些数据将作为在芝加哥大学临床合作者指导下在患者中进行安全性和有效性研究的IDE申请的基础。第二阶段的目标如下：目标1。研制用于犬功能和安全性测试的无线脑电记录仪。目标2.设计和测试用于犬研究的外部硬件和软件。目标3.评价犬体内无线ECoG器械29天的功能和稳定性。目标4。评价犬体内29天植入物的生物相容性和安全性。第二阶段计划是EIC实验室（诺伍德，MA）、Sigenics（芝加哥，IL）、伊利诺伊理工学院（芝加哥，IL）和芝加哥大学之间的合作。阵列 制造和测试将在EIC进行。ASIC设计和采购将由Sigenics管理。IIT将监督遥测系统和电气接口的开发。动物研究将在芝加哥大学进行。我们估计，在美国，用于切除性癫痫手术颅内监测的无线设备市场每年将达到1200万至1900万美元。将寻求扩大市场，以包括提供基于刺激的治疗的其他临床监测应用和设备。预计研究设备的市场也将不大。

DESCRIPTION (provided by applicant): Surgical resection of epileptogenic foci is a commonly practiced and often beneficial treatment for patients suffering debilitating seizures arising from otherwise intractable epilepsy. The success of this procedure depends on the ability of the medical team to precisely locate the epileptogenic zones in the patient's brain and to identify important cortical regions that must be avoided during resection. The accepted best method for locating the epileptogenic zones is to record seizure activity with subdural electrodes implanted chronically for up to seven days. The electrodes are connected by cables to external recording equipment for the duration of the monitoring period. This invasive procedure has disadvantages: (a) A lengthy and costly hospital stay is required. (b) Long-duration implantations increase the likelihood of serious and potentially lethal infection. (c) A family member or sitter must be with the patient at all times. (d) Being in bed and tethered to the wall by numerous cables makes it difficult for some patients to cope. (e) There is a risk of intracerebral hemorrhage if the cables are accidentally pulled and the grids move. (f) Ten to twenty percent of patients do not have enough seizures during the hospitalization period to identify the epileptic zone with certainty. We propose to develop wireless subdural electrodes that will avoid these disadvantages. Wireless electrodes will allow complete closure of the craniotomy used for surgical placement and will avoid the use of the transcranial multiwire cables that connect the electrodes to data processing hardware. The ability to close the dura and skull, avoiding wired conduits to the brain, will reduce the risk of morbidity due to infection and reduce cost by allowing the patient to leave the hospital for the majority of the monitoring phase. A potentially significant benefit of wireless outpatient monitoring is the ability to provide longer monitoring periods, up to 29 days, which allows the recording of habitual seizure activity while the patient is on their full regimen of ant-seizure medication. Localization based on habitual seizure activity will improve outcomes of the resective surgery and expand the population of patients for whom surgery is an option. The Phase II objective is to establish the diagnostic capabilities and safety of wireless devices over 29-day implantation period in dog using a side-by-side comparison to clinical, hardwired subdural grids and recording systems as a basis for the assessment. Program success is defined as achieving clinically equivalent seizure localization data to conventional grids and equivalent or reduced pathology. These data will serve as the basis for an IDE application for a safety and efficacy study in patients under the direction of our clinical collaborators at the University of Chicago. The Phase II Aims are as follows: Aim 1. To develop wireless ECoG devices for functional and safety testing in dog. Aim 2. To design and test external hardware and software for dog studies. Aim 3. To evaluate wireless ECoG device function and stability over 29 days in dog. Aim 4. To evaluate biocompatibility and safety of 29 day implants in dog. The Phase II program is a collaboration between EIC Laboratories (Norwood, MA), Sigenics (Chicago, IL), Illinois Institute of Technology (Chicago, IL), and the University of Chicago. Array fabrication and testing will be conducted at EIC. ASIC design and procurement will be managed by Sigenics. IIT will oversee the telemetry system and electrical interface development. Animal studies will be conducted at the University of Chicago. We estimate the market for wireless devices used in intracranial monitoring for resective epilepsy surgery will be $12-19M annually in the United States. Expansion of the market to include other clinical monitoring applications and devices that provide stimulation-based therapies will be sought. A modest market for research devices is also anticipated.