FitMi VNS: The First Automated Home Therapy System for Exercise-Paired Vagus Nerve Stimulation After Stroke

FitMi VNS：首个用于中风后运动配对迷走神经刺激的自动化家庭治疗系统

• 批准号: 10413806
• 负责人: Nizan Friedman
• 金额: $ 84.54万
• 依托单位: FLINT REHABILITATION DEVICES
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-06-01 至 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10413806
• 关键词: Activities of Daily Living; Adverse event; Automobile Driving; Chronic; Clinic; Clinical Trials; Computer software; Data; Development; Devices; Event; Exercise; Feasibility Studies; Feedback; Funding; Goals; Hand; Health Insurance Portability and Accountability Act; Home; Impairment; Implant; Individual; Intervention; Leg; Life; Living Standards; Manuals; Measures; Methods; Motor; Movement; Nervous System Trauma; Neuronal Plasticity; Outcome Measure; Participant; Pathway interactions; Patients; Performance; Persons; Phase; Physiological Processes; Pilot Projects; Protocols documentation; Public Health; Randomized; Recovery; Rehabilitation therapy; Research; Risk; Rotation; Safety; Small Business Innovation Research Grant; Societies; Stroke; Supervision; System; Testing; Texas; Therapeutic; Therapeutic Effect; Touch sensation; Training; Translations; United States National Institutes of Health; Universities; Upper Extremity; Vagus nerve structure; arm; base; chronic stroke; clinically significant; cohort; commercialization; design; disability; efficacy study; experience; feasibility testing; functional restoration; improved; improved outcome; in vivo; in vivo evaluation; motor impairment; motor recovery; neurological rehabilitation; neurotransmitter release; novel; post stroke; primary outcome; recruit; remote monitoring; remote patient monitoring; risk mitigation; safety and feasibility; safety study; safety testing; sensor; software systems; stroke rehabilitation; usability; vagus nerve stimulation; verification and validation; wireless

It is estimated that 1 in 6 people worldwide will experience a stroke, with 50-70% experiencing chronic movement impairment. While intensive motor training can partially restore motor function in these individuals, the improvement is often incomplete, as the physiological processes driving recovery through motor training alone are insufficient to fully restore function. Vagus Nerve Stimulation (VNS) paired with motor training has recently emerged as a promising method to improve movement recovery by increasing neuroplasticity through targeted release of neurotransmitters. In a recent pilot study with individuals with chronic stroke, Kimberley et al. found large, clinically significant improvements in upper extremity movement ability following an intervention of manually-triggered exercise-paired VNS compared to control, also confirming that it was safe to deliver this stimulation at home. However, a manually triggered VNS system has critical limitations. First, motor recovery is sensitive to stimulation timing but it is impractical to optimize stimulation timing with a manually-triggered system in the clinic, and impossible to do so at home. Second, operating a manually triggered system distracts therapists from optimally supporting patients during therapy. An automated, closed-loop VNS delivery system could improve both the practicality and therapeutic effects of exercise-paired VNS. Thus, for this Direct-to-Phase II SBIR, we propose to complete development of a robust, FDA compliant, automatically triggered exercise-paired VNS system called FitMi VNS system and to test the safety and usability of this system in the clinic and at home in an exploratory clinical trial with individuals with chronic stroke. Our specific aims for this Phase II project are to: Aim 1) Complete an integrated FitMi VNS software system to mitigate potential risks and develop a HIPAA compliant remote monitoring platform; Aim 2) Complete bench-top verification and validation testing and supervised, in-vivo safety testing of FitMi VNS in individuals with chronic stroke (n = 10). Here, our goal is for >99% of stimulations to be delivered with optimal timing and no adverse events or safety-related issues; and Aim 3) Complete an at-home safety and feasibility study of FitMi VNS in individuals with chronic stroke (n = 20). Our hypothesis is that FitMi VNS will safely provide closed-loop, exercise-paired VNS both in the clinic and at home. We will evaluate the therapeutic benefit of FitiMi VNS in a large scale randomized controlled efficacy study in Phase III. At the end of this project, we will have rigorously refined the FitMi VNS system and performed initial safety and feasibility testing in the clinic and at home. If successful, FitMi VNS will be the first system to provide automated, closed-loop exercise- paired VNS for stroke rehabilitation, leading to a step change in motor recovery for individuals with stroke.

据估计，全球六分之一的人会中风，其中50-70％的人经历了慢性 运动障碍。虽然强化运动训练可以部分恢复运动功能 个人，改进通常是不完整的，因为生理过程通过 仅运动训练就不足以完全恢复功能。迷走神经刺激（VNS）与 运动训练最近已成为一种有前途的方法，可以通过增加运动来改善运动恢复 神经塑性通过靶向释放神经递质的释放。在最近的一项试点研究中 慢性中风，金伯利等。发现上肢大大，临床上显着改善 与手动触发的锻炼能力VN进行干预后的运动能力与 控制，还确认在家里提供这种刺激是安全的。但是，手动触发 VNS系统有关键的局限性。首先，运动恢复对刺激时机敏感，但它是 在诊所中使用手动触发的系统优化刺激时间不切实际，而不可能 在家做。其次，操作手动触发的系统会分散治疗师的注意力 在治疗过程中支持患者。自动闭环VNS交付系统可以改善两者 运动配对VN的实用性和治疗作用。因此，对于这个直接到相的II SBIR，我们 建议完成稳健，符合FDA的，自动触发锻炼的发展 VNS系统称为FITMI VNS系统，并在诊所和AT中测试该系统的安全性和可用性 在探索性临床试验中与患有慢性中风的个体进行了回家。我们在此阶段的具体目标 II项目是：AIM 1）完成一个集成的FITMI VNS软件系统，以减轻潜在风险和 开发符合HIPAA的远程监控平台；目标2）完成台面验证和 验证测试和监督，体内安全测试对患有慢性中风的人的FITMI VNS（n = 10）。在这里，我们的目标是以> 99％的刺激来提供最佳时机，没有不良事件 或与安全有关的问题；目标3）在fitmi vns中完成家庭安全性和可行性研究 慢性中风的个体（n = 20）。我们的假设是FITMI VNS将安全提供闭环， 在诊所和家里进行运动配对的VNS。我们将评估Fitimi VNS的治疗益处 在第三阶段的大规模随机对照疗效研究中。在这个项目结束时，我们将拥有 严格完善了FITMI VNS系统，并在诊所进行了初始安全性和可行性测试 在家里。如果成功，FITMI VNS将是第一个提供自动闭环运动的系统 - 配对的VN进行中风康复，导致中风患者的运动恢复逐步变化。