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。存在许多药物疼痛干预措施，但会增加 阿片类药物使用障碍（OUD）。因此，迫切需要非成瘾性疼痛治疗。一个非- 成瘾性疼痛治疗是神经反馈，或脑电图（EEG）生物反馈， 来调节与生理放松相关的大脑状态。神经反馈已被用于治疗疼痛， 多种医疗条件，但传统上需要前往诊所。在过去的十年里，便携式脑电图 头戴式耳机已经进入市场，可以读取脑电波，并通过蓝牙向移动的设备发送信号。这 技术提供了一个机会，创造一个新的移动的平台，使病人的痛苦， 在家的神经反馈移动的神经反馈的原型由杜克进行了试点：在使用三个月后， 患有慢性疼痛的患者报告疼痛更少，愤怒更少，压力更小，抑郁更少，睡眠更好。 CrossComm是一家位于北卡罗来纳州的小型企业，拥有20多年成功构建人类- 计算机接口并将其生产为商业可用。在这个STTR第一阶段项目中， CrossComm和杜克将合作开发一个商业化的移动的神经反馈应用程序，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是开发一个商业化的移动的 神经反馈应用程序通过完善一个高效，直观的移动的应用程序的用户体验，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，正如移动的应用程序会议所证明的那样， 人机界面（HCI）标准。目标2是测试新的商业化移动的应用程序的可行性 N=30例慢性疼痛患者处方阿片类药物。他们将获得新的移动的神经反馈应用程序 和一个脑电图耳机，并被指示练习10分钟的神经反馈课程，每周4次，持续12 周之后，将测量移动的应用程序的使用情况、满意度和可用性，以确定 商业化的移动的神经反馈应用程序，用于慢性疼痛患者处方阿片类药物。如果上述 STTR第一阶段的目标得到满足，这将支持在一个商业环境中测试商业就绪的移动的神经反馈应用程序。 STTR II期双盲随机临床试验，入组阿片类药物治疗慢性疼痛患者。 这项研究具有创新性，因为它开发了数字技术疗法（移动的医疗应用） 其独特地使神经调节（神经反馈）方法能够进行疼痛管理， 方便、安全地让慢性疼痛患者随时随地使用。预期成果是制定一项 便携式，低成本，非成瘾性治疗开创了一个新的框架，使用平移设备以外的 临床设置有效的疼痛管理，以帮助打击阿片类药物危机在美国。我们的最终目标是创造 一个移动的应用平台，能够获得利益相关者/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.