electroCore said on April 7, 2026 that the first eight patients have been enrolled in an investigator-led study testing its gammaCore non-invasive vagus nerve stimulation (nVNS) device as an adjunctive treatment for PTSD.
The trial, run by Acacia Clinics in collaboration with the Vagus Nerve Society and sponsored by the society, plans to enroll up to 40 adults and will follow participants over a 12-week treatment period. electroCore provided an educational grant and supplied gammaCore devices for the study.
The protocol lists the primary safety endpoint as the incidence of treatment-related serious adverse events. The primary efficacy endpoint is the change from baseline in the Clinician-Administered PTSD Scale (CAPS-5) total score at 12 weeks. Secondary measures include the PTSD Checklist (PCL-5) and Clinical Global Impression (CGI) ratings.
Study leadership is credited to Danielle DeSouza, MSc, PhD, Vice President of Research at Acacia Clinics, and Noah DeGaetano, MD. Acacia Clinics, founded in 2018 and known for fMRI-guided TMS, is positioning this investigator-led trial to generate preliminary safety and effectiveness data to inform further research in neuropsychiatric uses of nVNS.
"The enrollment of the first eight patients marks an important milestone in advancing research into non-invasive neuromodulation as a potential adjunctive treatment for PTSD," said Dr. Peter Staats, electroCore's chief medical officer and president of the Vagus Nerve Society.
Dr. DeSouza added, "There remains a significant unmet need for effective adjunctive therapies, and this research will help further our understanding of the role vagus nerve stimulation may play in addressing both the neurological and physiological components of PTSD."
The company said the study is expected to run for about 10 months and will produce preliminary data to guide future trials. No results have been released yet.
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Tags: gammaCore, vagus nerve stimulation (nVNS), PTSD, clinical trial, Acacia Clinics
Topics: Non-invasive brain stimulation, Neuromodulation, Vagus nerve & taVNS