Spark Biomedical is partnering with Battelle Memorial Institute and Hazelden Betty Ford Foundation to develop an artificial intelligence (AI) algorithm designed to proactively detect and manage opioid withdrawal symptoms and cravings. The initiative is funded by a $318,875 Small Business Innovation Research (SBIR) grant from the National Institute on Drug Abuse (NIDA).
Proactive Symptom Detection
The initial phase of the clinical trial will focus 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 complete clinical assessments, including the 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.
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.
Dr. Navid Khodaparast, Ph.D., study Principal Investigator and Co-founder & Chief Science Officer at Spark, stated, "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... 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."
