Personalized tVNS device for research and treatment of PTSD

项目总结/摘要 创伤后应激障碍（PTSD）困扰着多达8%的美国人，并且正在迅速增长， 包括自2005年以来因创伤后应激障碍而领取残疾福利的退伍军人增加了400%， 在COVID-19大流行的患者和临床医生的病例中。仅在退伍军人事务部， 超过150亿美元。不幸的是，创伤后应激障碍的治疗往往是无效的，有副作用，和高发病率。 辍学生经皮迷走神经刺激（tVNS）已显示出治疗症状的希望， PTSD，但目前还没有商业化的tVNS设备，以满足研究人员的需求， 临床可用的解决方案。问题包括器械形状因素（接口）、给药策略以及 根据患者需要调整刺激滴定。这个项目建立在我们团队的早期原型之上， 创建一个临床研究工具，将加速社区（和我们）的能力，以确定最 有效使用tVNS改善PTSD患者的生活质量。 非侵入性迷走神经刺激的当前实施方式不满足患者或研究人员对神经刺激的需求。 创伤后应激障碍患者需要改进的设备来将这种有前途的技术转化为商业产品， 灵活、舒适、便携，有效地满足了这一人群的需求。临床科学家 需要一种满足tVNS研究复杂需求的系统，包括高质量刺激， 可编程刺激参数控制，以及生理反应和患者使用的记录;同时 还提供了供患者在家使用的简单用户界面。 在这个项目中，我们将开发埃夫伦的凤凰实验室，这将是第一个tVNS设备能够满足 研究人员和患者的复杂需求。在第一阶段，我们将开发刺激器和传感器 硬件（Aim 1A），既可作为患者家庭使用系统，也可作为系留研究员 刺激器接下来，我们开发了基于PC的研究人员界面（Aim 1B），该界面提供了完全 优化和配置刺激器以供临床使用，并安全地集成来自其他系统的数据， 将数据存储/传输到安全的数据库中。最后，我们将实现可用性测试（目标2）， 研究人员和志愿者获得反馈的性能和舒适的系统。

Project Summary/Abstract Post-Traumatic Stress Disorder (PTSD) afflicts as many as 8% of Americans and is growing rapidly, including a 400% increase in veterans receiving disability benefits for PTSD since 2005 and an expected uptick in cases for patients and clinicians from the COVID-19 pandemic. In the VA alone, the cost of treating veterans is over $15B. Unfortunately, treatments for PTSD are often ineffective, have side effects, and high rates of dropout. Transcutaneous Vagal Nerve Stimulation (tVNS) has shown promise in treatment of symptoms of PTSD but there are no commercially available tVNS devices that meet the needs of researchers to develop clinically usable solutions. Problems include device form factors (interface), dosing strategy, and the ability to adjust stimulation titration based on patient need. This project builds on our team’s early stage prototypes to create a clinical research tool that will accelerate the community’s (and our) ability to determine the most efficacious use of tVNS to improve quality of life for patients with PTSD. Current implementations of non-invasive vagal nerve stimulation do not meet patient or researcher needs for PTSD patients. Improved devices are needed to move this promising technology to a commercial product that is flexible, comfortable, portable, and effectively addresses the needs of this population. Clinician-scientists require a system which meets the complex needs for tVNS research, including high quality stimulation, programmable stimulation parameter control, and logging of physiologic response and patient usage; while also presenting a simple user interface for home use by patients. In this project we will develop Evren’s Phoenix Laboratory, which will be the first tVNS device able to meet these complex needs for both researchers and patients. In Phase I we will develop the stimulator and sensor hardware (Aim 1A) that serves both as the patient home-use system and also as the tethered researcher stimulator. Next we develop the PC-based researcher interface (Aim 1B) that provides the ability to fully optimize and configure the stimulator for clinical use, as well as securely integrate data from other systems and store/transfer the data into secure databases. Lastly, we will implement usability testing (Aim 2) with researchers and volunteers to obtain feedback on the performance and comfort of the system.