Spark Biomedical, a leader in wearable neurostimulation technology, has completed enrollment for its pivotal phase II clinical trial, offering hope to newborns with Neonatal Opioid Withdrawal Syndrome (NOWS). This trial investigated how non-invasive transcutaneous auricular neurostimulation (tAN®) therapy could reduce the need for prolonged opioid treatment for NOWS. Funded by the National Institute on Drug Abuse (NIDA) under the HEAL Initiative, the trial was conducted at The Medical University of South Carolina, UT Southwestern Medical Center, and the University of Texas Health Science Center at San Antonio.

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The study focused on infants over 33 weeks gestational age, many of whom endured severe withdrawal symptoms such as tremors, irritability, and difficulty feeding as a result of in-utero opioid exposure. It examined how transcutaneous auricular neurostimulation (tAN) therapy, when combined with current morphine treatments, affected the time required for medical readiness for discharge. Participants are now being monitored for two years to assess long-term neurodevelopmental outcomes.  
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About the study Chief Science Officer Dr. Navid Khodaparast shared,

“Following FDA Breakthrough Device Designation, the SPROUT trial was the next step in moving us closer towards an FDA approval of a non-invasive neurostimulation treatment for NOWS infants. Spark extends our gratitude to all our university partners, and NIDA for funding this important clinical trial.”

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Each year, thousands of infants begin life in the grips of NOWS. Spark Biomedical's CEO, Daniel Powell, emphasized how this clinical trial aimed to provide these newborns with a better start:

"Since the first days of Spark, we've had the vision to create a version of our neurostimulation platform designed specifically for the most vulnerable victims of the opioid epidemic. I am immensely proud of the work this team has done to advance our novel treatment for Neonatal Opioid Withdrawal Syndrome and look forward to getting the Sparrow Fledgling into the hands of Neonatologists across the country as fast as possible."

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