NeuroMAP System for Clinical Research

用于临床研究的 NeuroMAP 系统

• 批准号: 9924671
• 负责人: Gianluca De Luca
• 金额: $ 53.59万
• 依托单位: ALTEC, INC.
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-12-01 至 2022-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9924671
• 关键词: Activities of Daily Living; Address; Adult; Affect; Algorithms; American; Amplifiers; Architecture; Assessment tool; Award; Behavior; Biomedical Engineering; Brain; Caring; Child; Clinical; Clinical Research; Complex; Computer software; Data Analyses; Development; Devices; Disease Progression; Electromyography; Environment; Equilibrium; Evidence based intervention; Exercise; Feasibility Studies; Gait; Gel; Health Resources; Healthcare; Hospitals; Impairment; Individual; Intervention; Intuition; Investigation; Investments; Involuntary Movements; Knowledge; Laboratories; Lead; Link; Market Research; Marketing; Measurement; Measures; Mission; Monitor; Motor; Motor Neurons; Movement; Muscle; Muscle Contraction; Musculoskeletal; National Institute of Neurological Disorders and Stroke; Needles; Nervous System Trauma; Nervous system structure; Neurologic; Neurologic Effect; Neurologist; Neuromuscular Diseases; Outcome; Outcome Measure; Parkinson Disease; Patients; Pediatric Neurology; Performance; Phase; Physical therapy; Procedures; Production; Rehabilitation therapy; Reporting; Research; Research Personnel; Sales; Signal Transduction; Skeletal Muscle; Skin; Small Business Innovation Research Grant; Specialist; Sports; Surface; Symptoms; System; Techniques; Technology; Testing; Time; Visualization; Wireless Technology; age related; base; clinical application; commercialization; data acquisition; data exchange; design; dexterity; disability; handheld mobile device; improved mobility; industry partner; manufacturing process; motor control; motor impairment; muscle strength; nervous system disorder; neural circuit; new technology; operation; patient population; peer; physical therapist; prevent; prototype; rehabilitation engineering; relating to nervous system; research clinical testing; sensor; tool; usability; user-friendly; wearable sensor technology; wireless fidelity

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

运动神经元是连接大脑和骨骼肌的最后一个神经回路，使身体能够运动。 调节运动能力的障碍目前影响着5000多万患有糖尿病的美国人。 各种神经或肌肉骨骼疾病。然而，运动神经元控制的缺陷， 这些条件很难辨别，因为目前的研究工具用于测量运动神经元活动 从骨骼肌中提取的信息仅限于针式肌电图（EMG）记录，这是侵入性的， 仅激发少数运动神经元，并且仅适用于高度受限的肌肉收缩。虽然 最近开发的表面EMG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，几乎没有关于潜在运动神经元放电的信息， 包括信号。因此，需要先进的评估工具，为临床研究人员提供 测量运动神经元控制的潜在缺陷，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原型准备满足这一需求。我们有 开发了一种独特的，非侵入性的后处理系统，可以准确测量 在步态、运动和日常生活活动期间，从身体佩戴的传感器获得个体运动神经元。通过 在第二B阶段SBIR中，我们现在建议将我们复杂的基于实验室的原型推进到一个交钥匙的、真实的- NeuroMAP™系统，满足商业化的多功能性、可用性和可行性要求 临床研究市场。我们将把现有的多组件系统整合成一个可用的， 无线传感器的可穿戴和移动的兼容系统 多种肌肉、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结果，以实现直观、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， 神经病学、物理治疗、运动康复和生物医学工程。通过这些努力， 通过战略投资，支持监管策略、制造流程和营销计划 从我们的行业合作伙伴Delsys公司，我们将提供一个有影响力的，可用的和验证的NeuroMAP™ 系统准备生产，营销和销售在1年内完成这一奖项。 1