Advancing epilepsy diagnosis with flexible, high-resolution thin-film electrodes

利用灵活的高分辨率薄膜电极推进癫痫诊断

基本信息

批准号：
10297290
负责人：
Robert Kyle Franklin
金额：
$ 183.89万
依托单位：
NEW YORK UNIVERSITY SCHOOL OF MEDICINE
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-03-01 至 2025-11-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10297290
关键词：
Advanced Development Affect American Animal Model Area Biology Brain Clinical Clinical Trials Collaborations Communities Computers Data Development Device Approval Device Designs Device Safety Devices Diagnosis Diagnostic Disease Drug resistance Edema Effectiveness Electrodes Engineering Enrollment Epilepsy Excision FDA approved Face Failure Film Freedom Frequencies Future Hemorrhage Human Individual Industrialization Inflammation Infrastructure Intervention Intractable Epilepsy Length of Stay Location Measurement Measures Medical Microelectrodes Modernization Monitor Morbidity - disease rate Morphologic artifacts Multi-Institutional Clinical Trial Neocortex Neurologic Neurosurgical Procedures New York Noise Notification Operative Surgical Procedures Outcome Pain Partial Epilepsies Patients Pattern Performance Phase Play Preclinical Testing Randomized Records Resistance Resolution Risk Rodent Role Safety Sales Sampling Scientific Advances and Accomplishments Scientist Seizures Signal Transduction Site Statistical Data Interpretation Sterilization Surveys Swelling System Technology Testing Therapeutic Thick Thinness Tissues Translating Universities Utah Work base biomaterial compatibility computerized data processing cost data acquisition data visualization density diagnostic value flexibility implantable device implantation improved interest large scale data liquid crystal polymer medical schools microstimulation microsystems miniaturize mortality neocortical nervous system disorder neuroinflammation neurotransmission next generation nonhuman primate novel patient safety patient tolerability personalized approach personalized medicine prototype relating to nervous system research clinical testing retina implantation safety study standard of care success

项目摘要

Project Summary To advance the development of next-generation personalized therapies for long-term seizure freedom, we urgently need technologies that improve seizure diagnostics while reducing risks associated with invasive neurosurgical procedures. Among the more than 1,000,000 Americans with uncontrolled focal epilepsy, many have poorly localized seizure foci. These individuals face the highest rates of ‘failure’ (i.e., ongoing seizures) after epilepsy surgery. That failure reflects the biology of their epilepsy as well as the overlap of seizure foci with essential cortical areas. However, limits of current technologies also play a critical role in the high failure rate as we are currently limited in our ability to sample wide regions of the neocortex (i.e., stereoEEG) or to record broad neocortical regions without inducing pain, swelling, and neuroinflammatory tissue damage (i.e., subdural grid and strip recordings). To meet this need for safer, more effective invasive electrode studies and simultaneously enable discovery to advance next-generation therapies, this UG3/UH3 clinical trial project leverages a successful, long-term collaboration between clinicians, engineers, material scientists, neuroscientists and industrial partners at New York University School of Medicine, New York University, Duke University, the University of Utah, Blackrock Microsystems, and Dyconex to translate modern thin-film technology into next generation FDA-approved implantable neurological devices. We have developed and extensively tested a novel electrode array based on liquid crystal polymer thin-film (LCP-TF) technology with partner Dyconex, AG. When combined with large-scale data acquisition systems, LCP-TF electrodes will provide higher quality neural recordings than existing FDA- approved electrode arrays, with improved safely and at an affordable cost. We propose to obtain traditional 510(k) approval from the FDA for short-term implantation (<30 days) of LCP-TF electrodes to (1) improve surgical tolerability for patients with neocortical, focal, drug-resistant epilepsy undergoing invasive electrode studies and (2) advance diagnostic capabilities to determine the location of seizure foci. Our preliminary work in a non-human primate animal model led to a prototype device nearly identical to the final device design planned for clinical testing. This work establishes supporting data for entry into preclinical testing in the 3-year UG3 phase (Aims 1-3) that will lead to 510(k)-approved devices (Aim 4) for a single-site, randomized-controlled pilot clinical trial in the 2-year UH3 phase (Aim 5) that will test the hypothesis that performing epilepsy diagnostic studies with LCP-TF electrodes, compared to CG electrodes, improves both surgical tolerability and diagnostic effectiveness. These efforts will advance the development of next-generation precision approaches to treating epilepsy as well as support future development of LCP-TF electrodes for other neurological disorders. Low-cost, FDA-approved LCP-TF electrodes have the potential to revolutionize the treatment of a wide range of neurological disorders

项目概要为了推进下一代个性化疗法的开发，以实现长期无癫痫发作，我们迫切需要改进癫痫诊断的技术，同时降低与侵入性相关的风险在超过 1,000,000 名患有不受控制的局灶性癫痫的美国人中，有许多人接受了神经外科手术。这些人的癫痫病灶定位不佳，“失败”率最高（即持续癫痫发作）。癫痫手术后的失败反映了他们癫痫的生物学特性以及癫痫病灶的重叠。然而，当前技术的局限性也在高失败率中发挥着关键作用。目前，我们对新皮质广泛区域（即立体脑电图）进行采样或记录广泛区域的能力受到限制。新皮质区域不会引起疼痛、肿胀和神经炎性组织损伤（即硬膜下网格和条带录音）。为了满足对更安全、更有效的侵入式电极研究的需求，同时使发现能够下一代疗法，这个先进的 UG3/UH3 临床试验项目利用了成功的、长期的 New 的上级、工程师、材料科学家、神经科学家和工业合作伙伴之间的合作约克大学医学院、纽约大学、杜克大学、犹他大学、贝莱德大学 Microsystems 和 Dyconex 将现代薄膜技术转化为 FDA 批准的下一代技术我们开发并广泛测试了一种基于植入式神经设备的新型电极阵列。与合作伙伴 Dyconex, AG 大规模结合液晶聚合物薄膜 (LCP-TF) 技术。数据采集系统，LCP-TF 电极将提供比现有 FDA 更高质量的神经记录经批准的电极阵列，经过安全改进且成本可承受。我们建议获得 FDA 对 LCP-TF 短期植入（<30 天）的传统 510(k) 批准电极 (1) 提高新皮质、局灶性、耐药性癫痫患者的手术耐受性进行侵入性电极研究，以及 (2) 先进的诊断能力以确定电极的位置我们在非人类灵长类动物模型中的初步工作产生了几乎相同的原型设备。这项工作为进入临床测试的最终设备设计建立了支持数据。 3 年 UG3 阶段（目标 1-3）的临床前测试将导致 510(k) 批准的设备（目标 4）为期 2 年的 UH3 阶段（目标 5）的单中心、随机对照试点临床试验将检验该假设与 CG 电极相比，使用 LCP-TF 电极进行癫痫诊断研究可以改善两者这些努力将促进下一代的发展。治疗癫痫的精确方法，并支持 LCP-TF 电极在其他领域的未来开发经 FDA 批准的低成本 LCP-TF 电极有可能彻底改变神经系统疾病。治疗多种神经系统疾病