electroCore, Inc. announced the publication of a peer-reviewed study in Frontiers in Neurology demonstrating that gammaCore non-invasive vagus nerve stimulation (nVNS) significantly reduces persistent symptoms associated with mild traumatic brain injury (mTBI). The observational study represents the first relatively large prospective investigation showing the potential benefits of nVNS as an adjunctive treatment for post-concussion symptoms.
Study Design and Patient Population
The study, entitled "Non-invasive vagus nerve stimulation is associated with the reduction in persistent post-concussion symptoms: an observational study," included 102 patients with persistent symptoms following mTBI. Researchers evaluated the adjunctive use of gammaCore with standard care, measuring outcomes across multiple domains of the Neurobehavioral Symptom Inventory (NSI).
Clinical Outcomes and Efficacy
Patients demonstrated significant reductions in 16 of 22 symptom categories measured by the NSI. The improvements encompassed key areas including post-traumatic headache, dizziness, difficulty concentrating, and depression. Approximately 34% of patients reported meaningful improvement in at least half of their persistent symptoms.
"This is the first relatively large, prospective study showing that non-invasive vagus nerve stimulation in conjunction with standard of care may improve multiple persistent symptoms of traumatic brain injury," said Michael Ament, MD, principal investigator and lead author of the study.
Treatment Timing and Safety Profile
The study revealed that improvements occurred regardless of treatment timing relative to injury. Benefits were observed both in patients treated within three months of injury and in those whose symptoms had persisted for over a year, suggesting that nVNS may be beneficial regardless of time since injury. Importantly, no device-related adverse events were reported during the study period.
Clinical Context and Unmet Need
The findings address a significant clinical gap in mTBI treatment. According to the CDC, approximately 2.5 million emergency department visits occur annually in the United States for traumatic brain injury, with 70-90% classified as mild.
"Until now, treatment has largely been limited to supportive care," said Peter Staats, MD, MBA, Chief Medical Officer of electroCore. "These findings highlight an important potential advance—not only for the general population, but also for the U.S. military, where 1-2% of service members experience a mild TBI annually."
Technology and Mechanism
gammaCore utilizes non-invasive vagus nerve stimulation technology to deliver targeted neuromodulation. The device represents part of electroCore's bioelectronic medicine portfolio, which includes both prescription and consumer wellness products utilizing non-invasive neuromodulation approaches.
