Bridging bench to bedside with aneurotechnology cross-development platform

通过神经技术交叉开发平台将工作台与床边桥接起来

• 批准号: 10640424
• 负责人: David Allenson Borton
• 金额: --
• 依托单位: PROVIDENCE VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-02-01 至 2027-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10640424
• 关键词: Acceleration; Address; Affect; Age; Algorithm Design; Algorithms; American; Amplifiers; Architecture; Brain; Capital; Caring; Chronic; Clinical Research; Collaborations; Communication; Communities; Complex; Computer software; Computers; Custom; Data; Detection; Development; Device or Instrument Development; Devices; Disease; Drug Costs; Economic Burden; Ecosystem; Electrodes; Electronics; Electrophysiology (science); Evaluation; Feedback; Future; Goals; Growth; Health Care Costs; Human Resources; Implant; Injury; Intellectual Property; Intervention; Investigation; Investments; Knowledge; Laws; Liquid substance; Logic; Longitudinal Studies; Manufacturer; Marketing; Medical; Medical Device; Mission; Nervous System; Nervous System Trauma; Neurologic; Neurology; Neurostimulation procedures of spinal cord tissue; Operating System; Parkinson Disease; Patients; Persons; Pharmaceutical Preparations; Pharmacologic Substance; Phase; Research; Resources; Risk; Sensorimotor functions; Services; Shapes; Sheep; Spinal; Spinal Cord; Spinal cord injury; System; Technology; Telemetry; Testing; Textiles; Therapeutic; Thinness; Time; Transistors; Translations; Tremor; United States Department of Veterans Affairs; United States Food and Drug Administration; Vertebral column; Veterans; Writing; bench to bedside; bioelectronics; chronic pain; cost; data acquisition; deep brain stimulator; density; design; first-in-human; flexibility; human study; implantable device; improved; in vivo; innovation; instrument; manufacture; medical implant; microchip; nervous system disorder; neural; neuroregulation; neurotechnology; new technology; next generation; novel; novel therapeutics; pharmacologic; pre-clinical; preclinical evaluation; preclinical study; premature; programs; research and development; research clinical testing; restoration; socioeconomics; spinal cord and brain injury; success; timeline; tool; wireless

Advancements in neurotechnology are shaping the future of medical care for those suffering from neurological illness, disease, and injury. Unfortunately, it can take decades to bring such advances from the benchtop to the bedside in service of our Veterans. The development, evaluation, optimization, and deployment of each subcomponent of a medical device is complex, and combinations of technologies are required to address the complex needs of Veterans with, for example, traumatic brain and spinal cord injuries. In fact, the last major neurotechnology translational success was arguably the deep brain stimulator (DBS) developed in the 1980’s, delivering electrical neuromodulation to the brain to reduce Essential and Parkinson’s Disease-related tremor, but were not approved by the Food and Drug Administration until 2002. While impressive technologies are on the horizon, including those supported by the Department of Veterans Affairs, the time, money, and scientific divide between benchtop successes and bedside therapeutic application is exceptionally vast. Bioelectronics are hyped as an alternative to drug interventions, but the reality is that the translation timelines for medical devices—and their success rates as therapeutic tools—mirror the slow and costly development of new pharmaceuticals rather than mirroring the lean, accelerated development of new electronics for the consumer market. This issue matters because the socioeconomic burden of neurological injury and disorders is significant. Spinal cord injuries (SCIs) alone are estimated to affect between 249,000 and 363,000 Americans (NSCISC), and roughly 42,000 people with SCIs are Veterans, an estimated $5M/patient over their lifetime in health care costs. Nearly half of all SCIs occur in people between the ages of 16 and 30, leaving many to live with the injuries for decades. The inefficiency of bringing new drugs to market is dubbed “Eroom’s” law, given the exponentially increasing cost of drug release—in contrast to Moore’s law, originally referring to the number of transistors on a microchip doubling every 2 years though the cost of computers is halved, but more generally illustrating the exponential growth for technologies over time. From a translational perspective, the efficiency of medical device innovation still has much more in common with pharmacological research and development (R&D) than it does with Moore’s law and consumer electronics. We propose the development of a hardware and software accelerator platform (“cross-development”, or xDev) for electrophysiology research and neurotechnology creation. Development of this platform would enable new research into spinal cord stimulation for sensorimotor restoration in SCI, as well as for continued investigation of spinal electrophysiology in closed-loop devices for chronic pain. The new tool will be used to accelerate design, development and deployment of neurotechnology by smoothing the transition between design phases, allowing rapid redesign and re-verification of neurotechnology components. The xDev platform maximizes the ability of neurotechnology device developers to test their tools with versatile interfaces, algorithms, and underlying chipsets, improving compatibility, cross-functionality, and inspiring new collaborations between technology developers. Strategic platform organization protects neurotechnology developers’ intellectual property, while improving modularity with tools from other manufacturers. Leveraging the xDev platform, we will demonstrate a new neurotechnology enabling chronic recording of spinal electrophysiology and fill a neuroscientific knowledge gap, connecting the fields of Restorative Neurology and therapeutic spinal cord neuromodulation.

神经技术的进步正在塑造神经系统疾病患者医疗保健的未来 不幸的是，这些进步从实验室到实际应用可能需要几十年的时间。 为我们的退伍军人提供床边服务的开发、评估、优化和部署。 医疗设备的子组件很复杂，需要结合多种技术来解决 退伍军人的复杂需求，例如，脑部和脊髓损伤实际上是最后一个主要损伤。 神经技术的成功转化可以说是 20 世纪 80 年代开发的深部脑刺激器 (DBS)， 电神经调节传递大脑以减少特发性和帕金森病相关的震颤， 但直到 2002 年才获得美国食品和药物管理局的批准。虽然令人印象深刻的技术正在出现 地平线，包括退伍军人事务部支持的那些，时间、金钱和科学 实验室成功与临床治疗应用之间的差距异常巨大。 被大肆宣传为药物干预的替代方案，但现实是医疗的转化时间表 设备及其作为治疗工具的成功率反映了新疗法的缓慢且昂贵的开发 药品，而不是反映消费者新电子产品的精益、加速开发 市场。 这个问题很重要，因为神经损伤和疾病的社会负担很大。 据估计，仅脊髓损伤 (SCI) 就会影响 249,000 至 363,000 名美国人 (NSCISC)，并且 大约 42,000 名 SCI 患者是退伍军人，估计每位患者一生的医疗保健费用为 500 万美元 近一半的 SCI 发生在 16 岁至 30 岁之间的人群中，导致许多人不得不忍受这种痛苦。 几十年来，新药上市的效率低下，被称为“埃鲁姆”定律。 药物释放成本呈指数级增加——与摩尔定律相反，摩尔定律最初指的是药物的数量 微芯片上的晶体管每两年增加一倍，尽管计算机的成本减半，但更普遍的是 从转化的角度来看，技术的效率随着时间的推移呈指数级增长。 医疗器械创新与药理学研究和开发仍有很多共同点 （研发）比摩尔定律和消费电子产品更重要。 我们建议开发硬件和软件加速器平台（“交叉开发”，或 xDev） 该平台的开发将实现新的电生理学研究和神经技术创建。 脊髓刺激用于 SCI 感觉运动恢复的研究以及后续研究 新工具将用于加速慢性疼痛闭环装置中脊柱电生理学的研究。 通过平滑设计阶段之间的过渡来设计、开发和部署神经技术， xDev 平台允许快速重新设计和重新验证神经技术组件。 神经技术设备开发人员使用多功能接口、算法和功能来测试其工具的能力 底层芯片组，提高兼容性、跨功能并激发之间的新合作 技术开发人员的战略平台组织保护神经技术开发人员的智力。 财产，同时利用其他制造商的工具提高模块化程度，我们将 展示一种新的神经技术，能够长期记录脊髓电生理学并填补 神经科学知识差距，连接恢复神经病学和治疗脊髓领域 神经调节。