NeuroMAP System for Clinical Research

运动神经元是连接大脑和骨骼肌的最终神经回路，使身体能够运动。 控制运动的能力受损目前影响着5000多万美国人 各种神经或肌肉骨骼疾病。然而，在运动神经元控制方面的缺陷是许多 这些情况很难辨别，因为目前的研究工具用于测量运动神经元的活动 来自骨骼肌的仅限于针状肌电(EMG)记录，这是有创性的，产生 只有几个运动神经元被解雇，而且只适用于高度受限的肌肉收缩。虽然 最近开发的表面肌电技术提供了一种非侵入性的替代方案，目前的系统仅提供 肌肉激活的粗略测量，很少或根本没有关于潜在运动神经元放电的信息 包括该信号。因此，需要先进的评估工具为临床研究人员提供 运动神经元控制潜在缺陷的测量，以更好地理解、评估和治疗 限制运动功能的残疾。我们最近的第二阶段SBIR原型已经准备好满足这一需求。我们有 开发了一种独特的、非侵入性的后处理系统，可以准确地测量 在步态、锻炼和日常生活活动中，来自身体佩戴的感应器的单个运动神经元。穿过 在这个阶段IIB SBIR，我们现在提议将我们基于实验室的复杂原型推进到交钥匙、真正的- 满足商业化通用性、可用性和可行性要求的Time NeuroMAP™系统 在临床研究市场上。我们将把现有的多组件系统集成到一个可用的、 可穿戴和移动兼容的无线传感器系统，具有可整合的皮肤传感器接口以支持 跨多个肌肉、运动和临床测试程序的用例。目前的后处理 软件架构将重新设计，采用实时算法、高级用户界面和自动化 报告运动神经元测量，实现直观、用户友好的操作。的可用性和可行性。 我们的设备将在成人和儿科领域的五个领先的临床研究合作伙伴中进行测试 神经学、物理治疗、运动康复和生物医学工程。通过这些努力，以及 通过战略投资支持监管战略、制造流程和营销计划 通过我们的行业合作伙伴Delsys，Inc.，我们将提供有效、可用和经过验证的NeuroMAP™ 系统在完成此奖项后1年内准备好生产、营销和销售。 1

Motoneurons are the final neural circuits that link the brain with skeletal muscles to enable the body to move. Impairments in the ability to regulate movement currently affect over 50 million Americans suffering from various neurological or musculoskeletal conditions. Yet the deficits in motoneuron control that underlie many of these conditions are difficult to discern because current research tools used to measure motoneuron activity from skeletal muscles are limited to needle electromyography (EMG) recordings, which are invasive, yield the firings of just a few motoneurons, and are only applicable to highly constrained muscle contractions. Although recently developed surface EMG techniques present a noninvasive alternative, current systems provide only gross measures of muscle activation with little to no information about the underlying motoneuron firings that comprise the signal. Advanced assessment tools are therefore needed to provide clinical researchers with measurements of underlying deficits in motoneuron control to better understand, evaluate, and treat disabilities that limit motor function. Our recent Phase II SBIR prototype is poised to meet this need. We have developed a unique, non-invasive, post-processing system that accurately measures the firing behavior of individual motoneurons from body-worn sensors during gait, exercise and activities of daily living. Through this Phase IIB SBIR, we now propose to advance our complex laboratory-based prototype into a turn-key, real- time NeuroMAP™ system that meets versatility, usability and feasibility requirements for commercialization in the clinical research marketplace. We will integrate the existing multi-component system into a usable, wearable and mobile compatible system of wireless sensors with conformable skin-sensor interfaces to support use-cases across multiple muscles, movements, and clinical test procedures. The present post-processing software architecture will be redesigned with real-time algorithms, advanced user-interfaces and automated reporting of motoneuron measurements for intuitive, user-friendly operation. The usability and feasibility of our device will be tested among five leading clinical research partners across the fields of adult and pediatric neurology, physical therapy, sports rehabilitation and biomedical engineering. Through these efforts, and through strategic investments to support the regulatory strategy, manufacturing process and marketing plan from our industry partner, Delsys, Inc, we will deliver an impactful, usable and validated NeuroMAP™ system ready for production, marketing and sales within 1 year of completing this award. 1