Handheld Vagus Nerve Stimulator Gets Emergency Approval for COVID-19 Use

Electric pulses open airways and could combat deadly “cytokine storm”

By Samuel K. Moore

The U.S. Food and Drug Administration has granted an emergency use authorization for treating suspected COVID-19 patients with a non-invasive vagus stimulator. The handheld device, made by electroCore, in Basking Ridge, N.J., sends a train of electrical pulses through the skin to a nerve within the neck. Research has shown this pulse train causes airways within the lungs to open and should even have a more general anti-inflammatory effect.

According to FDA’s authorization, the gammaCore Sapphire CV device are often used either reception or during a clinic or hospital to “acutely treat adult patients with known or suspected COVID-19 who are experiencing exacerbation of asthma-related [shortness of breath] and reduced airflow, and for whom approved drug therapies aren’t tolerated or provide insufficient symptom relief.”

The vagus nerves line either side of the neck and connect structures deep within the brain with the body’s internal organs. (See “The Vagus Nerve: A Back Door For Brain Hacking,” June 2015.) Medical device makers have been taking advantage of this brain-organ highway to treat epilepsy, depression, postpartum bleeding, and more. ElectroCore’s device is already approved for both acute and long-term treatment of migraine and cluster headaches.

However, the corporate was founded on the rear of research into the vagus stimulations’ effect on airways, says Dr. Peter Staats, electroCore’s chief medical officer. “Early on, once we were studying airway activity, we asked patients if they experienced anything ,” he recalls. “An early patient said ‘My headache went away.’” Once the company was established, headache became the initial focus. Conveniently, an equivalent set of stimuli used for migraine and headache—two minutes of 25 pulses per second of a 5000 Hz signal—also work for the lungs. “We’ve kind of come full circle,” says Staats.

With reference to the lungs and COVID-19, the device appears to possess a two-pronged effect. The first, opening up the top terminals of the lung’s airways, is mediated by signals rising the nerve into the brain, says Staat. The second, a separate anti-inflammatory effect, appears to be caused by signals traveling down the nerve into the body. The working theory is that this second signal has an impact on cytokine production. Cytokines are a broad class of small proteins that cells use to signal to every other, a number of which play a task in inflammation. Their overproduction can cause a “cytokine storm syndrome” that’s been seen in some COVID-19 patients, where an immune reaction spins out of control and may pack up the lungs and other organs.

Under the FDA authorization, the device is merely approved to be used during the COVID-19 national emergency. However, researchers have several ongoing clinical trials and FDA has invited the corporate to hunt more permanent approval, consistent with electroCore CEO Dan Goldberg. And he expects the corporate to continue exploring the utilization of noninvasive vagus stimulation (nVNS) for other maladies, he says. “Under the pandemic circumstances we’re laser focused, but we still believe that nVNS may be a broad platform for a spread of clinical indications,” he says.