Neurostimulation Clinical Trial Shows Promising Initial Results in Easing Opioid Withdrawal Symptoms in Newborns

Dr. Dorothea Jenkins, M.D and assistant adjusting neurostimulation settings on the Spark Biomedical Roo gadget to alleviate withdrawal signs in infants born with Neonatal Opioid Withdrawal Syndrome.

The Roo Transcutaneous Auricular Neurostimulation (tAN) earpiece delivers stimulation in and across the ear to activate nerve branches that launch endogenous opioids (endorphins) which bind to the vacant opioid receptors and ease the withdrawal signs.

Dallas, Texas, Aug. 05, 2020 (GLOBE NEWSWIRE) — Whereas situations of Neonatal Opioid Withdrawal Syndrome (NOWS) are nonetheless on the rise, and the eyes of the nation stay targeted on a pandemic, the Medical College of South Carolina (MUSC) and Spark Biomedical, Inc. are tackling opioid withdrawal in newborns — probably the most harmless victims of the still-looming opioid disaster. This groundbreaking scientific trial pairs Spark’s Transcutaneous Auricular Neurostimulation (tAN™) gadget for newborns — the Roo — with the pediatric neurostimulation experience and amenities of MUSC to develop a secure and simpler withdrawal aid resolution for NOWS.

In most situations, newborns present process NOWS expertise tremors, high-pitched crying, seizures, feeding difficulties, gastric discomfort, and temperature instability. To alleviate signs, oral morphine, an opioid with further side-effects, is run. The morphine remedy is then step by step weaned down over a two to four-week interval, with the typical hospital keep lasting 21 days —all spent in a NICU setting at a mean price of $53,000 per new child, based on a research revealed within the US Nationwide Library of Drugs, Nationwide Institutes of Well being.

“This neurostimulation is giving the mind slightly little bit of a lift of its personal endogenous opioids to maybe scale back the necessity for exogenous morphine, which has all these harmful negative effects when delivered for extended durations of time on this crucial neurodevelopmental window,” stated Bashar Badran, Ph.D., an assistant professor within the Faculty of Drugs Division of Psychiatry and Behavioral Sciences who makes a speciality of mind stimulation. 

Within the Spark/MUSC NOWS trial, tAN remedy delivers mild electrical stimulation to cranial nerve branches on and across the new child’s ear. It’s believed that tAN prompts particular mind areas to sign the discharge of endogenous opioids (endorphins), which bind to the vacant opioid receptors and ease the withdrawal signs. This research was designed to ship tAN earlier than every scheduled morphine dose, permitting for the endorphins to supplant the necessity for morphine. The method successfully reduces complete morphine administration and, finally, days spent within the NICU.

Scientific outcomes up to now:

  • Since April 2020, three newborns have enrolled in and accomplished the scientific trial.
  • From the beginning of tAN remedy administration, all newborns had been safely weaned off morphine inside a mean of 10 days — sooner than the 21-day nationwide common.

“Whenever you see infants who’re withdrawing from opioids, you instantly really feel horrible for them. They are in quite a lot of misery. They’re jittery, crying continuously, laborious to appease and console, and will have quick respiration and vomiting,” stated Dorothea Jenkins, M.D., a professor of pediatrics who makes a speciality of newborns. “This open-label scientific trial is designed to indicate {that a} seven- to 10-day morphine wean is secure and achievable with tAN, which might be a major enchancment over commonplace of care,” Jenkins stated. “With three infants efficiently finishing the protocol, we’re inspired that this remedy might provide profit.”

Principal Investigator, Dr. Navid Khodaparast, Ph.D., Spark Biomedical’s Chief Science Officer, stated, “Whereas we now have seen success with tAN™ remedy in our grownup opioid withdrawal scientific trial, we weren’t certain how this remedy strategy would generalize to newborns with NOWS. Now that the trial is underway, the outcomes are past our expectations, and most significantly, have improved the lives of the newborns and their households.”

The MUSC/Spark NOWS scientific trial is funded by a $217,690 SBIR grant from the Nationwide Institutes of Well being HEAL initiative (1R43DA050360-01).

About Spark Biomedical, Inc. 

Spark Biomedical, Inc. is a Texas-based medical gadget firm creating wearable neurostimulation options for opioid withdrawal aid. The Spark crew is devoted to serving to the world overcome, heal, and obtain by way of the usage of wearable neurostimulation.

About MUSC Kids’s Well being

MUSC Kids’s Well being is altering what’s doable for youngsters and their households by offering the pediatric scientific and analysis experience each youngster deserves and wishes. From selling wholesome life to providing life-saving therapies, Kids’s Well being delivers complete and compassionate care to kids all through South Carolina and past.

Our built-in kids’s well being care system consists of the MUSC Shawn Jenkins Kids’s Hospital and Pearl Tourville Ladies’s Pavilion  l positioned on the Charleston peninsula, which is without doubt one of the most patient- and family-centered and technologically superior hospitals for youngsters and their households in america; the Charles P. Darby Research Institute, the place pediatric analysis groups conduct vital and ongoing efforts; the R. Keith Summey Medical Pavilion in North Charleston, which presents ambulatory care, a surgical procedure heart, specialty care, and after-hours clinics; and eventually, expanded depth and breadth of experience in a number of neighborhood places all through the Lowcountry, providing main, pressing and specialty care in particular person or through telehealth.  For extra data go to

The analysis reported on this publication is supported by the Nationwide Institute on Drug Abuse of the Nationwide Institutes of Well being below award quantity 1R43DA050360-01. The content material is solely the accountability of the authors and doesn’t essentially symbolize the official views of the Nationwide Institutes of Well being.

Jackie Powell
Spark Biomedical

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