The initiative will enroll up to 40 adults with PTSD for 12 weeks of adjunctive treatment with gammaCore Sapphire, a handheld non-invasive vagus nerve stimulator. Safety will be tracked by the incidence of significant adverse events attributed to nVNS. The primary efficacy outcome is change from baseline in CAPS-5 total score at week 12 after a four-week run-in. Secondary outcomes include changes in PCL-5 and Clinical Global Impression at week 12.
Acacia Clinics and the Vagus Nerve Society have launched the study to evaluate gammaCore Sapphire as an add-on to standard PTSD care. The investigator-led program, anticipated to run about 10 months, is sponsored by the Vagus Nerve Society, with electroCore providing an educational grant and devices. The study will be led by Acacia’s VP of Research and is positioned to generate early safety and effectiveness data on a prescription nVNS device already commercialized in other indications.
Strategically, this is a low-capital, signal-seeking move that probes psychiatric use cases without committing to a registrational pathway. The small sample size, 12-week horizon, and reliance on a pre-post design suggest an evidence-building step to de-risk a future randomized, sham-controlled study. Outsourcing sponsorship to a professional society adds clinical credibility and buffers perceptions of direct commercial influence, while embedding the work at a neuromodulation-focused clinic aligns with the likely early adopters if the signal is positive. The tension is clear: neuromodulation in PTSD is attractive as an adjunctive, non-pharmacologic option, but durable efficacy in heterogeneous populations has been hard to show without rigorous controls. CAPS-5 is an appropriate anchor but susceptible to rater drift and expectancy effects in open-label settings, underscoring the importance of methodology if this is to inform regulatory dialogue.
For sites, the operational lift is modest relative to device implants or biologics: patient training on a handheld device, adherence monitoring, and rater-standardized CAPS-5 administration. That makes this attractive to TMS and behavioral health centers looking to broaden device-based offerings. The assessment burden is nontrivial, though; consistent rater training and blinded outcome review would meaningfully strengthen interpretability. For sponsors and CROs, this is a template for lean device pilots in behavioral health, with potential to layer in remote data capture and adherence telemetry. For regulators, any positive signal will raise predictable questions about durability, generalizability across trauma subtypes, and the need for sham control to address placebo and engagement effects inherent to patient-operated neuromodulation. Payers will look for magnitude of benefit relative to established psychotherapies and pharmacotherapies, and whether an adjunctive device improves remission rates or accelerates response.
What to watch next is less the topline from this pilot than the design of the follow-on trial. A multicenter, sham-controlled study with centralized rating and predefined concomitant therapy management will be necessary to support labeling discussions. Adherence and dosing fidelity data will be critical, as will safety in real-world use outside tightly supervised settings. If the signal is directionally positive, expect electroCore and partners to engage FDA on an IDE-supported pathway and to define clinically meaningful changes on CAPS-5 tied to functional outcomes. The risk is a modest open-label effect that fails to translate under sham control, or operational variability that obscures a true signal. The opportunity is a scalable, clinic-friendly adjunct that could be slotted into existing neuromodulation workflows if efficacy and tolerability hold up under scrutiny.
