UNC School of Medicine researchers will lead a $3.4 million clinical trial to examine how a non-medication treatment, like a one-of-a-kind wearable device, can calm the body after a traumatic event.
Each year, about 40-million people in the United States go to emergency departments after traumatic events like car crashes or sexual assault. In the days and weeks afterward, many develop acute stress reaction (ASR) symptoms—such as anxiety, trouble sleeping, difficulty concentrating, pain, dizziness, and lightheadedness. If these symptoms don’t improve, longer‑term problems can develop, including ongoing pain, post traumatic stress, and depression.
To address this major health problem, the UNC Institute for Trauma Recovery at the UNC School of Medicine will lead a clinical trial in collaboration with Spark Biomedical, a wearable neurostimulation company, to test how the lightweight, innovative device can calm the body’s stress response soon after a traumatic event.
The Sparrow Link tAN System is worn on a patient’s ear and gently stimulates nerves involved in the body’s natural rest and recovery processes. The device is designed to help calm the body after a traumatic event, reduce early stress symptoms, and lower the risk of longer-term stress-related problems.
The US Department of Defense has invested $3.4 million for this Phase 2 clinical trial, led by principal investigator Samuel McLean, MD, MPH, director of the UNC Institute for Trauma Recovery and professor of psychiatry and emergency medicine at the UNC School of Medicine.
“There is an urgent need for effective interventions to prevent the development of these ‘invisible wounds,” McLean said. “Fortunately, advances in research methods and technology have created an opportunity to develop interventions to prevent symptoms associated with ASR. We look forward to initiating this important study of this lightweight, portable, easy-to-use non-invasive neurostimulation system, which could potentially be administered to patients in the early aftermath of severe trauma to reduce acute stress symptoms and prevent the transition to chronic symptoms.”
This double-blind, sham-controlled trial is expected to enroll 120 patients experiencing ASR resulting from motor vehicle collisions, beginning late 2026. Participants will be prescribed the Sparrow Link tAN System which attaches to the skin by the ear via a small earpiece. They will be wearing the device twice a day for 30-minutes over the course of a 2-week period. Spark Biomedical will provide the neurostimulators for the 2.5 year study.
“Traumatic events that lead to acute stress reaction require quick intervention to help prevent maladaptive neurological changes that could manifest into PTSD,” said Navid Khodaparast, PhD, co-founder & Chief Science Officer at Spark Biomedical. “This collaboration with the UNC Institute for Trauma Recovery reflects our long-standing focus on translating neuroscience into practical, safe, treatment solutions. We are committed to developing noninvasive neurostimulation approaches to those suffering from ASR and other stress-related neurological disorders.”
This trial is part of a broader effort at the UNC Institute for Trauma Recovery to develop both medication and non-medication interventions that reduce acute stress symptoms and prevent chronic posttraumatic stress and related disorders.
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About UNC Health:
UNC Health is a state entity and an affiliated enterprise of the University of North Carolina system, comprised of nearly 20 hospitals and more than 900 clinics along with the clinical patient care programs of the UNC School of Medicine (SOM). It exists to improve the health and well-being of North Carolinians and others we serve and to further the teaching mission of the University of North Carolina SOM. UNC Health provided more than $800 million in Uncompensated Charity Care during the past five years. Our hospitals have received numerous awards and recognition for quality care, patient safety, and the overall patient experience.
About Spark Biomedical:
Spark Biomedical, Inc. is a leading U.S.-based medical device developer, committed to unlocking the potential of bioelectronic medicine and bringing to market novel wearable neurostimulation treatment options in neurological health, women’s health, and hemostasis. 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 has received funding from federal institutions, such as the NIH and DoD, and continues to partner with private and academic institutions. Spark Biomedical is empowering a better way forward for the future of patient care and medical technology. For more information, visit www.sparkbiomedical.com
This ASR research is supported by the DoD under award number HT9425-24-1-1108. The content presented in this release is solely the responsibility of the authors and does not necessarily represent the official views of the DoD.
UNC School of Medicine contact: Brittany Phillips, communications specialist for UNC Health | UNC School of Medicine