Interaxon, along with Celéri Health and pain expert Dr. Ronald D. Siegel, is testing a therapeutic intervention to help people better manage their chronic and acute pain. With the prevalence of pain and its multidimensional repercussions, this non-opioid alternative consisting of mindfulness tools, EEG biofeedback and psychoeducation, could offer an accessible and safer option to alleviate both patients' symptoms and economic burden.

A recent study uncovered that over 50 million adults experience chronic pain in the US alone. According to the National Institute of Health on Drug Abuse, 21 to 29% of patients who are prescribed opioids for their pain end up misusing them, with 8 to 12% developing an opioid use disorder. With more than 70% of overdose deaths being opioid-involved, Congress has recently put forth the Non-Opioids Prevent Addiction in the Nation (NOPAIN) Act—legislation to increase access to non-opioid pain management alternatives. Interaxon and Celéri Health, a leader in chronic pain care data and data analytics, have launched a study on the effectiveness of an affordable, drug-free digital intervention that pain patients can easily access and complete from the comfort of home.

"In collaboration with our partners at Celéri Health and with Dr. Ronald Siegel, Interaxon has developed a sophisticated system that can be used to treat chronic pain," says Dr. Walter Greenleaf, Interaxon's Chief Science Officer. "Our system combines next-generation wearable sensor technology with a sophisticated pain-reduction therapeutic program. Our mobile app-based system is affordable and practical, opening up the possibility of dramatically improving the health and wellbeing of those who are burdened by chronic pain."

Over a 7-week period, the pain management of fifty study participants suffering from chronic pain will be tested as they undergo programming including the Transforming Pain eCourse and biofeedback meditation training, both by Muse?, Interaxon's consumer product brand. Celéri Health co-founders Michael Fishman, MD, and Jason Pope, MD, will assess participants using a cold pressor test and patient reported outcomes measures, including the clinically-validated PROMIS-29 multidimensional pain scale to detect changes in pain, anxiety, depression, physical function, sleep and quality of life.

"Chronic pain is the least data-driven chronic condition in the world, and we at Celéri Health are changing this," states Jon Brilliant, CEO of Celéri Heath. "We are thrilled to be partnering with Interaxon and using Muse? to bring objective data, along with our extensive patient reported outcomes data, to how we measure outcomes and make treatment decisions for people living with pain."

The Transforming Pain eCourse, currently available on a Muse? iOS app, was created in partnership with Ronald D. Siegel, PsyD, a mindfulness practitioner, chronic pain expert and part-time Assistant Professor of Psychology, at Harvard Medical School. The 65 sessions led by Dr. Siegel explore pain education, behavioural therapy techniques and pain-oriented mindfulness tools designed to transform one's perception and relationship with pain to improve quality of life.

"The course is designed to simultaneously address several aspects of chronic pain disorder," explains Dr. Siegel. "It uses mindfulness practices to increase distress tolerance, gain perspective on pain-amplifying thoughts, and interrupt the natural tendency to amplify pain sensations through hypervigilance and accompanying muscle tension. It also includes a program of incremental rehabilitation to help participants re-engage in meaningful life activities."

Throughout the study, each participant will also have access to a Muse? brain-sensing headband, a focused attention meditation tool. Using biofeedback technology, the Muse? headband and app will help participants identify in real-time when their mind is wandering towards thoughts about their pain and coach them back to a neutral stimulus.

"A cornerstone treatment of pain is self-management of mood, sleep, comfort, and function. Muse biofeedback combined with pain education is a key component to a multimodal treatment plan that engages the patient in their own care and builds healthy habits and coping skills," adds Dr. Fishman. "As an interventional pain care expert, I take great care to emphasize the importance of self-management for all my patients. Through our biosignal research with Interaxon, I hope to be able to further understand the different pain phenotypes so as to inform treatment decisions to help our patients get better and stay better."

The study is expected to demonstrate an improvement in the experience of pain, behavioural health issues, depression, anxiety and sleep. Once results are available later this year, Interaxon hopes to bring the Muse? Transforming Pain Course and Mind Meditation intervention to market as a valuable low-barrier alternative to prescription pain relievers. With one in five American adults living with pain, it's important to consider the overarching costs on quality of life, medical expenditure, the economy, and the opioid crisis. With chronic pain's damaging ramifications, Interaxon's pain program has the potential of offering an effective, non-addictive strategy to pain management.

About the MUSE-PAIN Study

This study is a prospective, open-label, non-randomized study to assess the use of the Muse-S meditation system in patients with chronic pain based on clinical follow-up data and exploratory cold pressor testing. Patients will be followed for seven weeks for main study endpoints and will continue to be followed for 12 months during a study extension period.  The first patient was enrolled on July 19, 2021 at the Center for Interventional Pain and Spine in Lancaster, Pennsylvania by Dr. Michael Fishman.  Please refer to www.clinicaltrials.gov (NCT04944459) for additional clinical trial details.

About Celéri Health

The mission of Celéri Health is to make pain a data driven disease by treating every encounter like a clinical study visit and capture of real-world evidence and data streams (Patient-reported Outcomes, diagnoses, drug history, procedure registry, wearables, and physiologic data).  Our Real World Outcomes? platform operationalizes the consensus expert recommendations and we are building the largest most comprehensive real world outcomes data set in pain, including procedure and device registries, medical history, physiological data, and pharmaceutical usage. 

About Interaxon Inc. (aka Muse?)

Our team of neuroscientists, meditation teachers, and engineers develop state-of-the-art experiences using research-grade EEG technology. Our goal is to help individuals build rewarding meditation and sleep practices to lead healthier, happier, and more connected lives through human-centered technology. Our award-winning biofeedback devices provide EEG-powered meditation and sleep tracking to help users tap into calm with real-time audio feedback on their internal state through the Muse? companion app. Deepen your practice with our premium offering of guided meditations and courses led by expert instructors. We make the intangible, tangible.