SBIR Phase II: A Patient-Centered Wearable System To Enable Data-Driven Decisions In Neuromuscular Disorders

这个小企业创新研究第二阶段项目将为神经肌肉市场提供一种新的辅助技术。在全国范围内，超过2万名美国人患有ALS，这是一种进行性神经退行性疾病。虽然存在增强和替代通信(AAC)工具来帮助这些患者控制计算机和其他设备，但对于运动或说话能力极其有限的用户来说，当前的解决方案都有明显的缺点。我们已经开发了非侵入性的神经肌肉传感技术，它可以检测肌肉的微小、有意的运动，并允许将微运动无线传输到计算机等设备上。虽然这项技术是为肌萎缩侧索硬化症患者开发的，但也可以在其他市场(如企业增强现实、消费电子产品、电脑游戏)中进行重新调整，只需最小的改动。大型科技公司对人机交互(HCI)的兴趣表明了对不疲劳、沉默和免提输入法的需求。该公司计划通过渠道合作伙伴向ALS市场销售，并将技术微型化，并为其他市场许可电路设计和软件，以实现数亿用户的采用。这个项目的智力优势来自于一种创新的方法，即使用专有的硬件/软件神经肌肉人机接口(HCI)系统来提高个人的增强和替代通信(AAC)的可用性。待开发的设备可以检测和传输皮肤表面肌电/神经电(EMG/ENG)电压信号。第二阶段的研究目标是：1)开发一个软件/固件机器学习(ML)平台，以增强现有设备，允许将EMG/ENG信号(神经肌肉激活数据)作为计算机命令进行可靠的检测/分类，以及2)在ALS患者的基于任务的(例如，网络浏览)协议中，对该设备的商业AAC集成进行用户测试。目标2中的测试将验证作为目标1的一部分开发的ML模型的准确性(使用在人类受试者中收集的数据)。目标2测试将包括对ALS参与者与AAC工具交互的准确性/错误率和性能时间的测量，包括设备的集成。预计第二阶段的软件/固件开发和其他增强将提高设备的准确性和延迟，与第一阶段生产的模型相比，并在真实世界的用户测试中显示可用性效果，作为全面AAC解决方案的一部分，以改善ALS患者的沟通能力。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。

This Small Business Innovation Research Phase II project will provide a novel assistive technology to the neuromuscular market. Nationwide, more than 20,000 Americans suffer from ALS, a progressive neurodegenerative disease. While augmentative and alternative communication (AAC) tools exist to aid these patients to control computers and other devices, current solutions all have significant shortcomings for users with extremely limited movement or speaking ability. We have developed non-invasive neuromuscular sensing technology which detects small, intentional movements of muscles, and allows micro-movements to be transmitted wirelessly to devices such as computers. While developed for ALS patients, this technology can be repurposed for other markets (e.g. enterprise augmented-reality, consumer electronics, computer gaming) with minimal alterations. The interest of large technology companies in human-computer interaction (HCI) demonstrates demand for nonfatiguing, silent, hands-free input methods. The company plans for sales to the ALS market through channel partners, and for miniaturizing the technology and licensing circuit design and software for other markets, to achieve adoption by hundreds of millions of users. This pathway enables worldwide distribution to ALS users through partner companies.The intellectual merit of this project results from an innovative approach to improve augmentative and alternative communication (AAC) usability for individuals, using a proprietary hardware/software neuromuscular human-computer interface (HCI) system. The device to-be-developed detects and transmits skin-surface electromyography/electroneurography (EMG/ENG) voltage signals. Phase II research objectives are to: 1) develop a software/firmware Machine Learning (ML) platform to enhance the existing device, to allow robust detection/classification of EMG/ENG signals (neuromuscular activation data) as computer commands, and 2) conduct user testing of a commercial AAC integration of the device, in a task-based (e.g. web-browsing) protocol for ALS patients. Testing in Objective 2 will validate accuracy of the ML models developed as part of Objective 1 (with data collected in human subjects). Objective 2 testing will include measurement of accuracy/error rates and performance-time, for participants with ALS interacting with AAC tools including integration of the device. It is anticipated that software/firmware developments and other enhancements in Phase II will improve accuracy and latency of the device, in comparison to models produced in Phase I, and show usability effect in real-world user testing as part of a full AAC solution to improve communication capabilities for ALS patients.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.