Spark Biomedical Awarded National Institute on Drug Abuse Funding to Develop AI-Algorithm for Opioid Withdrawal and Cravings Detection

Dallas, TX (Sept. 16, 2024) – Spark Biomedical, a leader in wearable neurostimulation technology, is partnering with prestigious research and behavioral health institutes, Battelle Memorial Institute and Hazelden Betty Ford Foundation, to revolutionize opioid use disorder (OUD) recovery treatment. The joint effort will explore the development of an artificial intelligence (AI) algorithm designed to proactively detect and manage opioid withdrawal symptoms and cravings.

Phase I: A Proactive Approach to Symptom Detection

Funded by a $318,875 Small Business Innovation Research (SBIR) grant from the National Institute on Drug Abuse (NIDA), the initial phase of their clinical trial will focus solely on data collection and development of a novel AI algorithm to proactively detect opioid withdrawal symptoms and cravings.

Patients participating in the trial at Hazelden Betty Ford will use two wearable devices equipped with advanced sensors that measure digital (i.e., heart rate, accelerometer, skin temperature, etc.) and physical biomarkers from sweat (cortisol, melatonin, etc.). Patients will also be completing gold-standard clinical assessments 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 compile the physiological sensor and clinical assessment data into an automated algorithm that detects opioid withdrawal symptoms and cravings.

Phase II: Advancing to Closed-loop Neurostimulation 

Upon completion of Phase I, the primary objective for Phase II is to apply the algorithm to initiate closed-loop neurostimulation using Spark Biomedical's FDA-cleared Transcutaneous Auricular Neurostimulation (tAN®) device, Sparrow® Ascent. Leveraging the algorithm and closing the loop with Sparrow Ascent allows for treatment to be triggered at a precise moment, eliminating withdrawal symptoms or cravings even before they are noticeable to the patient. This proactive approach to treating opioid withdrawal symptoms and cravings is designed to make treatment more effective and efficient, empowering patients to more easily comply with their treatment plans and reducing the likelihood of returning to use and overdose.

Dr. Navid Khodaparast, Ph.D., study Principal Investigator and Co-founder & Chief Science Officer at Spark, noted, "By leveraging the AI expertise of Battelle and substance use disorder treatment expertise of Hazelden Betty Ford, we are strongly positioned to advance our understanding of opioid withdrawal and cravings management. For years, the gold standard for assessing OUD symptoms has been 'paper & pencil' assessments. Unfortunately, these methods are limited due to subjectivity and lack of physiological markers. A transformative solution encompassing AI early detection paired with wearable neurostimulation treatment could significantly enhance patient treatment retention rates for improved patient outcomes. It's a big step forward in the fight to end the opioid epidemic."

About Spark Biomedical

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

Spark has received funding from federal institutions, NIH and DoD, and continues to partner with private and academic institutes. Spark leverages its neuroscience and engineering expertise to empower healthcare providers and researchers with innovative, evidence-based tools designed to address complex care situations which exceed the capabilities of existing treatment options. Spark Biomedical is paving a better way forward for the future of patient care and medical technology. For more information, visit sparkbiomedical.com.

About Battelle

Every day, the people of Battelle apply science and technology to solving what matters most. At major technology centers and national laboratories around the world, Battelle conducts research and development, designs and manufactures products, and delivers critical services for government and commercial customers. Headquartered in Columbus, Ohio since its founding in 1929, Battelle serves the national security, health and life sciences, and energy and environmental industries. For more information, visit www.battelle.org.

For more information about this clinical trial and its impact please contact Udim Obot at udim.obot@sparkbiomedical.com.