Personalized tVNS device for research and treatment of PTSD

项目摘要/摘要 创伤后应激障碍(PTSD)困扰着多达8%的美国人，而且还在迅速增长， 包括自2005年以来领取创伤后应激障碍伤残津贴的退伍军人人数增加了400%，预计将出现上升 针对新冠肺炎大流行的患者和临床医生的病例。仅在退伍军人管理局，治疗退伍军人的费用 超过150亿美元。不幸的是，创伤后应激障碍的治疗通常是无效的，有副作用，而且 辍学。经皮迷走神经刺激(TVNS)在治疗慢性阻塞性肺疾病症状方面显示出良好的前景。 创伤后应激障碍，但目前还没有商业化的tVNS设备来满足研究人员开发的需求 临床可用的解决方案。问题包括设备外形因素(接口)、给药策略和 根据患者需要调整刺激性滴定。这个项目建立在我们团队的早期原型之上，以 创建一个临床研究工具，以加速社区(和我们)确定最 有效使用tVNS改善PTSD患者的生活质量。 目前实施的非侵入性迷走神经刺激不能满足患者或研究人员对 创伤后应激障碍患者。需要改进的设备才能将这项前景光明的技术转化为商业产品 灵活、舒适、便携，并有效地满足了这一人群的需求。临床医生-科学家 需要一个满足TVNS研究的复杂需求的系统，包括高质量的刺激， 可编程刺激参数控制，并记录生理反应和患者使用情况； 还提供了供患者在家中使用的简单用户界面。 在这个项目中，我们将开发Evren的凤凰实验室，这将是第一个能够满足 这些复杂的需求对研究人员和患者都是如此。在第一阶段，我们将开发刺激器和传感器 既充当患者家庭使用系统又充当受困研究人员的硬件(目标1A) 刺激器。接下来，我们开发基于PC的研究人员界面(Aim 1B)，该界面提供完全 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和 将数据存储/传输到安全数据库。最后，我们将通过以下方式实现可用性测试(目标2 研究人员和志愿者获得关于系统性能和舒适度的反馈。

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.