Wireless ECoG Recording for Epilepsy Monitoring

用于癫痫监测的无线 ECoG 记录

• 批准号: 8524363
• 负责人: Stuart F Cogan
• 金额: $ 96.72万
• 依托单位: EIC LABORATORIES, INC.
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-08-15 至 2015-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8524363
• 关键词: Adverse effects; Ambulatory Monitoring; Animals; Ants; Beds; Biological Sciences; Brain; Brain Part; Canis familiaris; Caring; Cerebral hemisphere hemorrhage; Chicago; Clinical; Collaborations; Computer software; Coupling; Craniotomy; Data; Development; Devices; Diagnostic; Disadvantaged; Disease Management; Distress; Dura Mater; Electrocorticogram; Electrodes; Electroencephalography; Epilepsy; Equipment; Excision; Family member; Freedom; Funding; Head; Histology; Hospitalization; Hospitals; Illinois; Implant; Implanted Electrodes; In Vitro; Infarction; Infection; Institutes; Intractable Epilepsy; Knowledge; Laboratories; Left; Length of Stay; Letters; Location; Maps; Market Research; Marketing; Measurement; Medical; Meningeal; Meninges; Methods; Modeling; Monitor; Morbidity - disease rate; Neurologic; Operative Surgical Procedures; Osteomyelitis; Outcome; Pathology; Patient Monitoring; Patients; Pharmaceutical Preparations; Phase; Physiologic pulse; Procedures; Regimen; Risk; Safety; Seizures; Side; Stimulus; System; Technology; Telemetry; Testing; Time; Tissues; United States; Universities; Wireless Technology; base; biomaterial compatibility; burden of illness; commercialization; computerized data processing; coping; cost; cranium; data acquisition; design; implantation; improved; innovation; patient population; performance site; programs; public health relevance; safety testing; success; transmission process

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.

描述（由申请人提供）：手术切除致癫痫灶是一种常用的治疗方法，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。手术的成功取决于医疗团队精确定位患者大脑中癫痫发生区域的能力，以及确定切除过程中必须避免的重要皮质区域的能力。定位癫痫区公认的最佳方法是用长期植入长达7天的硬膜下电极记录癫痫发作活动。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)住院时间长，费用高。(b)长时间植入增加了严重和潜在致命感染的可能性。(c)必须有一名家庭成员或保姆一直陪伴在病人身边。(d)躺在床上，用许多电缆拴在墙上，使一些病人难以应付。(e)如果电缆不小心被拉扯，网格移动，有脑出血的危险。10%至20%的病人在住院期间没有足够的癫痫发作，无法确定癫痫区。我们