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

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.PROJECT NARRATIVE To combat the opioid crisis, there is a critical need to develop a non-addictive pain treatment that is safe, effective, low-cost, and accessible for patients with chronic pain, a group at elevated risk of opioid use disorder. The current proposal is innovative because it develops and tests feasibility of a commercial-ready mobile application interface using digital health technologies that uniquely enables a neuromodulatory (neurofeedback) approach to pain management than can be performed easily by patients with chronic pain anytime, anyplace. If this research is successful, it will enable commercialization of a mobile pain management application that will fundamentally change patients’ ability to manage pain effectively on their own without reliance on opioids.