Using Mobile Devices for Neurofeedback to Reduce Opioid Use in Chronic Pain

摘要 五分之一的美国人患有慢性疼痛。存在许多药理疼痛干预措施，但会增加 阿片使用障碍(OUD)。因此，迫切需要非成瘾性疼痛治疗。一个非- 上瘾的疼痛治疗是神经反馈，或脑电(EEG)生物反馈，训练患者 来调节与生理放松相关的大脑状态。神经反馈已被用来治疗疼痛 多种疾病，但传统上需要前往诊所。在过去的十年中，便携式脑电图仪 耳机已经上市，可以读取脑电波，并通过蓝牙向移动设备发送信号。这 技术为创建新的移动平台提供了机会，使疼痛患者能够进行 家里的神经反馈。移动神经反馈的原型是由杜克大学试行的：在使用三个月后， 慢性疼痛的患者报告说疼痛更少，愤怒更少，压力更小，抑郁更少，睡眠更好。 CrossComm是一家总部位于北卡罗来纳州的小企业，拥有20多年的成功构建人类- 计算机接口，并将其生产成商业可用。在这个STTRI期项目中， CrossComm和Duke将合作开发一款商业化的移动神经反馈应用程序，并测试其 使用阿片类药物治疗慢性疼痛的患者的可行性。目标1是开发一种商业化的移动设备 神经反馈应用程序通过提炼高效、直观的移动应用程序用户体验，识别更有效的 提供听觉反馈和改善端到端用户体验的方式。该应用程序将被构建 根据健壮性和可维护性的商业标准，移动应用会议证明了这一点 人机界面(HCI)标准。目标2是测试这款新的商业化移动应用的可行性 N=30例慢性疼痛患者服用阿片类药物。他们将获得新的移动神经反馈应用程序 和EEG耳机，并被指导练习10分钟的神经反馈课程，每周4次，共12次 几周。之后，将对移动应用程序的使用率、满意度和可用性进行衡量，以确定 商业就绪的移动神经反馈应用程序，用于慢性疼痛患者的处方阿片类药物。如果出现上述情况 STTR第一阶段的目标已经实现，这将支持在 STTRII期双盲随机临床试验，纳入慢性疼痛患者的处方阿片类药物。 这项研究具有创新性，因为它开发了数字技术疗法(移动医疗应用) 这使得能够执行神经调节(神经反馈)方法来进行疼痛管理 随时随地被慢性疼痛患者轻松、安全地使用。预期的结果是发展一种 便携式、低成本、非上瘾治疗开创了一种使用外部平移设备的新框架 为有效的疼痛管理提供临床环境，以帮助对抗美国的阿片类药物危机。我们的最终目标是创造 移动应用平台处于有利地位，可以获得利益相关者/投资者对商业化的支持 并通过减少慢性疼痛患者的疼痛症状和阿片类药物的使用来减轻OUD的负担。

Abstract One in five Americans has chronic pain. Many pharmacological pain interventions exist but increase risk of opioid use disorder (OUD). As a result, there is an urgent need for non-addictive pain treatments. One non- addictive pain treatments is neurofeedback, or electroencephalogram (EEG) biofeedback, which trains patients to regulate brain states linked to physiological relaxation. Neurofeedback has been used to treat pain in multiple medical conditions, but traditionally has required travel to clinics. In the past decade, portable EEG headsets have arrived to market that read brainwaves and send signals to mobile devices via Bluetooth. This technology affords an opportunity to create a novel mobile platform to enable patients with pain to conduct neurofeedback at home. A prototype of mobile neurofeedback was piloted by Duke: after three months of use, patients with chronic pain reported less pain, less anger, less stress, less depression, and better sleep. CrossComm, a North Carolina-based small business, has a 20+ year history of successfully building human- computer interfaces and producing them to be commercially available. In this STTR Phase I project, CrossComm and Duke will collaborate to develop a commercial-ready mobile neurofeedback app and test its feasibility among patients using opioids to treat chronic pain. Aim 1 is to develop a commercially-ready mobile neurofeedback app by refining an efficient, intuitive mobile app user experience, identifying more effective ways of providing auditory feedback, and improving the end-to-end user experience. The app will be built according to commercial standards of robustness and maintainability, as evidenced by the mobile app meeting Human Computer Interface (HCI) criteria. Aim 2 is to test feasibility of the new commercially-ready mobile app with N=30 patients with chronic pain prescribed opioids. They will be given the new mobile neurofeedback app and an EEG headset and be instructed to practice 10-minute neurofeedback sessions, 4 times a week, for 12 weeks. After, mobile app usage, satisfaction, and usability will be measured to determine feasibility of the commercial-ready mobile neurofeedback app for patients with chronic pain prescribed opioids. If the above STTR Phase I aims are met, this will support testing the commercial-ready mobile neurofeedback app in an STTR Phase II double-blind randomized clinical trial enrolling patients with chronic pain prescribed opioids. This research is innovative because it develops digital technology therapeutics (mobile medical applications) that uniquely enable neuromodulatory (neurofeedback) approaches to pain management to be performed easily and safely by patients with chronic pain anytime, anyplace. The expected outcome is development of a portable, low-cost, non-addictive treatment pioneering a new framework using translational devices outside the clinic setting for effective pain management to help combat the opioid crisis in the US. Our end goal is to create a mobile app platform that is well-positioned to gain stakeholder/investor support towards commercialization and alleviates the burden of OUD by reducing pain symptoms and opioid use in patients with chronic pain.