Spark Biomedical receives funding from the National Institute on Drug Abuse to develop an AI algorithm to detect opioid withdrawal and cravings

Spark Biomedical is collaborating with Battelle Memorial Institute and Hazelden Betty Ford Foundation to develop an AI-powered, wearable, closed-loop neurostimulation system to improve treatment retention in opioid withdrawal and reduce relapse and overdose rates.

Dallas, TX, Sept. 12, 2024 (GLOBE NEWSWIRE) — Spark Biomedical, a leader in wearable neurostimulation technology, is collaborating with renowned research and behavioral health institutes, Battelle Memorial Institute and the Hazelden Betty Ford Foundation, to revolutionize the treatment of opioid use disorder (OUD). The joint effort will explore the development of an artificial intelligence (AI) algorithm designed to proactively detect and treat opioid withdrawal symptoms and cravings.

Phase I: A proactive approach to symptom detection

Spark Biomedical's clinical trial is funded by a $318,875 Small Business Innovation Research (SBIR) grant from the National Institute on Drug Abuse (NIDA) and will focus exclusively on data collection and development of a novel AI algorithm to proactively detect opioid withdrawal symptoms and cravings in the first phase.

Patients enrolled in the study at Hazelden Betty Ford will use two wearable devices equipped with sophisticated sensors that measure digital (e.g., heart rate, accelerometer, skin temperature, etc.) and physical biomarkers from sweat (cortisol, melatonin, etc.). Patients will also complete gold standard clinical tests for opioid withdrawal and cravings: Clinical Opiate Withdrawal Scale, Short Opioid Withdrawal Scale-Gossop, and the Opioid Cravings Visual Analog Scale. Battelle's team will combine the physiological sensor and clinical test data into an automated algorithm that detects opioid withdrawal symptoms and cravings.

Phase II: Further development towards closed-loop neurostimulation

After completing Phase I, the primary goal of Phase II is to apply the algorithm to initiate closed loop neurostimulation using Spark Biomedical's FDA-approved transcutaneous auricular neurostimulation (tAN®) device, Sparrow® Ascent. By leveraging the algorithm and closing the loop with Sparrow Ascent, treatment can be initiated at a specific time, eliminating withdrawal symptoms or cravings before they are felt by the patient. This proactive approach to treating opioid withdrawal symptoms and cravings is expected to make treatment more effective and efficient, enable patients to more easily adhere to their treatment plans, and reduce the likelihood of relapse and overdose.

Dr. Navid Khodaparast, Ph.D., principal investigator and co-founder and chief science officer at Spark, noted, “By leveraging Battelle's AI expertise and Hazelden Betty Ford's treatment expertise in substance use disorder, we are in a strong position to advance our understanding of opioid withdrawal and craving. For years, paper-and-pencil assessment has been the gold standard for assessing OUD symptoms. Unfortunately, these methods are limited due to subjectivity and lack of physiological markers. A transformative solution that includes AI early detection combined with wearable neurostimulation treatment could significantly increase patient treatment retention rates, thereby improving treatment outcomes. This is a huge step forward in the fight against the opioid epidemic.”

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About Spark Biomedical

Spark Biomedical, Inc. is a leading U.S. medical device developer dedicated to unlocking the potential of bioelectrical medicine and bringing to market novel wearable neurostimulation treatment options in the areas of mental health, women's health, hemostasis, pediatrics and chronic pain.

Spark receives funding from federal agencies, NIH, and DoD, and continues to collaborate with private and academic institutions. Spark uses its neuroscience and engineering expertise to provide healthcare providers and researchers with innovative, evidence-based tools designed to address complex care situations that exceed the capabilities of existing treatment options. Spark Biomedical is paving a better path for the future of patient care and medical technology. For more information, visit sparkbiomedical.com.

About Battelle

Every day, Battelle employees apply science and technology to solve the problems that matter most. In major technology centers and national laboratories around the world, Battelle conducts research and development, designs and manufactures products, and provides critical services to government and commercial customers. Headquartered in Columbus, Ohio, since its founding in 1929, Battelle serves the national security, healthcare and life sciences, and energy and environmental industries. For more information, visit www.battelle.org.

About the Hazelden Betty Ford Foundation

Utilizing science, love and the wisdom of lived experience, the Hazelden Betty Ford Foundation is a force of healing and hope for individuals, families and communities affected by substance abuse and mental illness. As the nation's leading nonprofit provider of comprehensive behavioral health care, the Foundation is a leader in helping society overcome stigma and overcome addiction. With a legacy that began in 1949 and includes the founding of the Betty Ford Center in 1982, the Foundation today has treatment centers and telehealth services nationwide and a network of collaborators across the health care system. Philanthropic support and a commitment to innovation drive continuous advances in care, research, programs and services to impact more lives. In addition to clinical care, Hazelden Betty Ford includes a graduate school, publishing division, research center, thought leadership and advocacy, professional and medical education programs, school-based prevention resources and a special program for children – with a commitment to diversity, equity and inclusion in all its endeavors. Learn more at HazeldenBettyFord.org.

For more information about this clinical trial and its impact, please contact Udim Obot at [email protected]

CONTACT: Udim Obot Spark Biomedical 682-336-0535 [email protected]