Vagus nerve stimulation (VNS) has gained attention in recent years as a promising tool for supporting everything from mood and sleep to pain and inflammation. But as interest grows, so do questions, especially around safety.
In this article, we’ll take a closer look at non-invasive, transcutaneous cervical VNS devices like Truvaga and gammaCore, developed by electroCore. These devices are applied to the neck and work by gently stimulating the vagus nerve, an essential nerve that influences heart rate, digestion, immune response, and more.
While the benefits of vagus nerve stimulation continue to be explored, it’s important to understand the safety profile of these technologies. Clinical research has evaluated these devices for a range of conditions, including migraines, cluster headaches, PTSD, sleep disturbances, and breathing issues, providing valuable insight into both their effectiveness and safety. Let’s dive into what the science says.
Are Vagus Nerve Stimulation Devices Safe?
One of the most reassuring aspects of electroCore’s non-invasive VNS devices, such as Truvaga and gammaCore, is their well-established safety profile. In a clinical study by Silberstein et al. (2016) involving patients with chronic cluster headaches, the device was shown to be well-tolerated, with no serious device-related adverse events reported.[1] This finding is particularly significant given the severity and intensity of cluster headache symptoms.
A larger study conducted by Tassorelli et al. (2018) focused on migraine treatment, also demonstrated a favorable safety profile.[2] Reported side effects were rare, mild, short-lived, occurred in only a small percentage of users, and did not lead to treatment discontinuation. The most commonly observed effects included:[3]
- Application site discomfort (reported by 9% of patients)
- Nasopharyngitis, or the common cold (6%)
- Dizziness (2%)
These results reinforce that non-invasive vagus nerve stimulation devices are generally safe and well-tolerated across diverse populations.
Is Vagus Nerve Stimulation Safe for Your Heart?
A common question around vagus nerve stimulation is its potential impact on the heart and whether it may affect cardiovascular function. Since the vagus nerve plays a key role in regulating parasympathetic signals to the heart, helping slow the heart rate from an elevated state to a more efficient rhythm[4], this is an understandable area of concern.
A study by Rubenstein Engel et al. (2015) specifically examined the cardiovascular safety of electroCore’s non-invasive VNS devices.[5] The findings showed no clinically meaningful cardiovascular adverse effects associated with the use of these devices, providing reassurance even for individuals with pre-existing heart conditions.
In fact, emerging research suggests that VNS may help normalize arrhythmias by supporting autonomic balance. However, it’s important to note that this particular use is not yet FDA-cleared or approved.
Does Vagus Nerve Stimulation Affect the Carotid Artery?
Another question sometimes raised about cervical vagus nerve stimulation is whether it could negatively impact the carotid artery, particularly in individuals with existing plaque buildup. Given the close anatomical relationship between the vagus nerve, carotid artery, and jugular vein within the carotid sheath on both sides of the neck, it’s a reasonable question to consider.
In all of electroCore’s clinical studies, spanning over 1,000 subjects, they have not observed any adverse vascular effects or local complications, even though the stimulation is delivered directly over the carotid artery region. While it’s always wise to speak with your healthcare provider about any pre-existing cardiovascular conditions, current evidence continues to support the safety of non-invasive VNS devices with no negative impact on carotid artery health.
Is Vagus Nerve Stimulation Safe for Long-Term Use?
While many studies focus on the short-term safety and effectiveness of vagus nerve stimulation, it’s equally important to consider its long-term impact. A review by Silberstein et al. (2020) evaluated the clinical use of electroCore’s non-invasive VNS devices over an extended period and found no new safety concerns associated with prolonged use.[6]
These findings suggest that VNS remains well-tolerated and safe, even with continued, long-term treatment. In fact, consistent use over time may enhance the benefits, as vagus nerve stimulation can help support ongoing improvements in nervous system regulation, stress resilience, and overall well-being.
Is Vagus Nerve Stimulation Effective?
While safety is paramount, effectiveness is equally important when evaluating any therapeutic intervention. Numerous clinical studies have demonstrated the benefits of non-invasive vagus nerve stimulation (VNS) across a variety of conditions, including migraines, cluster headaches, sleep disturbances, and symptoms related to stress and mood regulation.
If you’re interested in a deeper dive into the clinical research supporting the effectiveness of VNS devices, both industry-wide and through specific electroCore studies on Truvaga and gammaCore, please refer to my detailed post on this topic here.
Personal Insights from a Healthcare Professional and Parent
As both a healthcare professional and a parent, I approach any new treatment with careful consideration. After thoroughly reviewing the clinical research on electroCore’s non-invasive VNS devices, both gammaCore and Truvaga, I feel confident in their safety and potential benefits. In fact, I’ve personally chosen to use the device with my 7-year-old daughter to support her sleep and vision challenges. The combination of a strong safety profile and non-invasive technology helped guide that decision.
That said, it’s important to clarify that Truvaga products are wellness devices recommended for adults 18 and older. gammaCore, on the other hand, is FDA-cleared for specific conditions in adults and adolescents and requires a prescription from your healthcare provider.[7] Any use of these devices in younger children or for off-label purposes should always be discussed with a qualified healthcare provider.
Overall, the research continues to support the safety and tolerability of transcutaneous cervical VNS devices, with most reported side effects being mild and temporary.[3] As with any treatment, individual responses may vary, so it’s important to work with a healthcare professional to determine what’s right for your needs or those of your loved ones.
For those seeking a safe, non-invasive way to feel calmer, think clearer, and sleep better, electroCore’s Truvaga products offer an accessible wellness solution backed by science and trusted technology. With a user-friendly design and strong safety profile, Truvaga makes it easier to incorporate the benefits of vagus nerve stimulation into your daily routine, safely and naturally.
Sources
[1] Silberstein, S. D., Mechtler, L. L., Kudrow, D. B., Calhoun, A. H., McClure, C., Saper, J. R., Liebler, E. J., & Rubenstein Engel, E. (2016). Non-invasive vagus nerve stimulation for the acute treatment of cluster headache: Findings from the randomized, double-blind, sham-controlled ACT1 study. Headache: The Journal of Head and Face Pain, 56(8), 1317–1332. https://doi.org/10.1111/head.12896
[2] Tassorelli, C., Grazzi, L., de Tommaso, M., Pierangeli, G., Martelletti, P., Rainero, I., Dorlas, S., Liebler, E., & Barbanti, P. (2018). Noninvasive vagus nerve stimulation as acute therapy for migraine: The randomized PRESTO study. Neurology, 91(4), e364–e373. https://doi.org/10.1212/WNL.0000000000005857
[3] Goadsby, P. J., de Coo, I. F., Silver, N., Tyagi, A., Ahmed, F., Gaul, C., Liebler, E., & Barbanti, P. (2018). Non-invasive vagus nerve stimulation for the acute treatment of episodic and chronic cluster headache: A randomized, double-blind, sham-controlled ACT2 study. Cephalalgia, 38(5), 959–969.
[4] Ng, G. A., Brack, K. E., & Coote, J. H. (2001). Effects of direct sympathetic and vagus nerve stimulation on the physiology of the whole heart: A novel model of isolated Langendorff perfused rabbit heart with intact dual autonomic innervation. Experimental Physiology, 86(3), 319–329.
[5] Engel, E. R., Blake, J., & Liebler, E. (2015). Non-invasive vagus nerve stimulator (gammaCore®) was not associated with meaningful cardiovascular adverse effects (P1.292). Neurology, 84(14 Supplement), P1.292. https://n.neurology.org/content/84/14_Supplement/P1.292
[6] Silberstein, S. D., Mechtler, L., Kudrow, D. B., Calhoun, A. H., McClure, C., Saper, J. R., Liebler, E., & Engel, E. R. (2020). Non-invasive vagus nerve stimulation for primary headache: A clinical update. Cephalalgia, 40(12), 1370–1384. https://journals.sagepub.com/doi/10.1177/0333102420941864
[7] U.S. Food and Drug Administration. (2020, March 26). 510(k) premarket notification for gammaCore Sapphire. https://www.accessdata.fda.gov/cdrh_docs/pdf19/K193260.pdf
Author bio:
Dr. Navaz Habib, is the bestselling author of “Activate Your Vagus Nerve,” and the newly released “Upgrade Your Vagus Nerve.” He is also the host of “The Health Upgrade Podcast.”
After graduating as class valedictorian from Canadian Memorial Chiropractic College in 2010 and went on to practice traditional chiropractic for years, until he utilized the power of functional medicine to transform his own health. Dr. Habib is the founder of “Health Upgraded” an online functional health consulting clinic, supporting optimal health by elevating the awareness and function of the vagus nerve.
