In 1997, the FDA approved implanted vagus nerve stimulation (VNS) devices as an adjunctive therapy for reducing the frequency and severity of epileptic seizures in pharmaco-resistant epilepsy patients who did not respond to medications. VNS therapy sends mild pulses to the vagus nerve at regular intervals throughout the day at a personalized dosage level of frequency and amplitude depending on the patient's specific needs.
By 1999, doctors began noticing a surprising range of unexpected positive side effects of VNS therapy such as fewer depressive symptoms, less systemic inflammation, and a reduction in severe headaches. In 2002, researchers published their initial observations about migraine headaches and VNS in a paper, “Vagal Nerve Stimulation Aborts Migraine in Patient with Intractable Epilepsy.”
Vagus nerve stimulation is part of a burgeoning field called “bioelectronics” or “electroceuticals” that uses clinically-tested devices to “hack” into the body’s nervous system to improve psychological and physical well-being.
Over the past two decades, vagus nerve stimulation therapy has been FDA approved to treat a variety of maladies. For example, in 2005, the FDA approved the use of VNS for the treatment of severe and recurrent unipolar and bipolar depression.
Historically, vagus nerve stimulation therapy has required a minimally invasive outpatient surgical procedure (which takes about an hour) to implant a small and discrete VNS gizmo under the skin below the collarbone that attaches to the vagus nerve.
On April 18, 2017, the FDA approved a first-of-its-kind noninvasive vagus nerve stimulator called the “gammaCore” for the acute treatment of pain associated with episodic cluster headaches for adult patients in the United States. The gammaCore is a hand-held device that is gently pressed against the neck by a patient who self-administers a prescriptive dose of VNS therapy through the skin to stimulate his or her vagus nerve.
This week, researchers orally presented a new paper, "Non-invasive Vagus Nerve Stimulation (nVNS) for the Acute Treatment of Migraine: A Randomized Controlled Trial," at the 18th Congress of the International Headache Society (IHC 2017) in Vancouver.
The latest study on non-invasive vagus nerve stimulation was a multicenter, double-blind, randomized, sham-controlled trial that evaluated the efficacy, safety and tolerability of nVNS using the gammaCore device in 243 patients with episodic migraines. The researchers found that non-invasive vagus nerve stimulation was a rapidly effective, well tolerated, and practical treatment for episodic migraine headaches.
In a statement about these findings, Cristina Tassorelli, director of the Headache Science Centre, National Neurological Institute C. Mondino Foundation and professor at the University of Pavia in Italy, who was the principal investigator of this clinical study, said: "Migraine is the third most common disease in the world, and one of the 10 most disabling diseases, which highlights a need for novel treatment options. The data supports the use of gammaCore to successfully treat a migraine, making the device a potentially valuable treatment for the millions of people who suffer from migraine."
The results from this randomized trial are clinically significant and corroborate other findings that non-invasive vagus nerve stimulation is well tolerated and has a low incidence of adverse side effects. There is one important caveat: Non-invasive VNS therapy is not yet approved by the FDA for the treatment of migraine headaches. However, this could happen sometime soon.
In the meantime, based on a groundswell of empirical evidence that stimulating the vagus nerve has a myriad of benefits, I’ve been curating a variety of holistic ways people can engage their vagus nerves without the use of any type of device. Of course, in treatment-resistant medical situations, VNS therapy offers an unbeatable and reliable prescriptive dose of clinically proven vagus nerve stimulation that will always require either an implanted or non-invasive device.
Nevertheless, there are a variety of everyday vagal maneuvers you can do just about any time or any place that will engage your vagus and increase your calming parasympathetic nervous system responses. To read more on this topic, check out my nine-part series “Vagus Nerve Survival Guide to Combat Fight-or-Flight Urges.”
Barbanti, Piero, Licia Grazzi, Gabriella Egeo, Anna Maria Padovan, Eric Liebler, and Gennaro Bussone. "Non-invasive vagus nerve stimulation for acute treatment of high-frequency and chronic migraine: an open-label study." The Journal of Headache and Pain 16, no. 1 (2015): 61. DOI: 10.1186/s10194-015-0542-4
Goadsby, P. J., B. M. Grosberg, A. Mauskop, R. Cady, and K. A. Simmons. "Effect of noninvasive vagus nerve stimulation on acute migraine: an open-label pilot study." Nature Reviews Neurology (2014): 986-993. DOI: 10.1038/nrneurol.2014.53
Hord, E. Daniela, M. Steven Evans, Sajjad Mueed, Bola Adamolekun, and Dean K. Naritoku. "The effect of vagus nerve stimulation on migraines." The Journal of Pain 4, no. 9 (2003): 530-534. DOI: 10.1016/j.jpain.2003.08.001