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

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

2 min read
A man holds the gammaCore Sapphire CV, a non-invasive vagus nerve stimulator, up to his neck.
Photo: electroCore

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

According to FDA’s authorization, the gammaCore Sapphire CV device can be used either at home or in 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 are not tolerated or provide insufficient symptom relief.”

The vagus nerves run along either side of the neck and connect structures deep in 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 company was founded on the back of research into the vagus nerve stimulations’ effect on airways, says Dr. Peter Staats, electroCore’s chief medical officer. “Early on, when we were studying airway activity, we asked patients if they experienced anything else,” he recalls. “An early patient said ‘My headache went away.’” Once the company was established, headache became the initial focus. Conveniently, the same 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 respect to the lungs and COVID-19, the device appears to have a two-pronged effect. The first, opening up the end terminals of the lung’s airways, is mediated by signals going up 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 effect on cytokine production. Cytokines are a broad class of small proteins that cells use to signal to each other, some of which play a role in inflammation. Their overproduction can cause a “cytokine storm syndrome” that’s been seen in some COVID-19 patients, where an immune response spins out of control and can shut down the lungs and other organs.

Under the FDA authorization, the device is only approved for use during the COVID-19 national emergency. However, researchers have several ongoing clinical trials and FDA has invited the company to seek more permanent approval, according to electroCore CEO Dan Goldberg. And he expects the company to continue exploring the use of noninvasive vagus nerve stimulation (nVNS) for other maladies, he says. “Under the pandemic circumstances we’re laser focused, but we continue to believe that nVNS is a broad platform for a variety of clinical indications,” he says.

The Conversation (0)
A photo showing machinery in a lab

Foundries such as the Edinburgh Genome Foundry assemble fragments of synthetic DNA and send them to labs for testing in cells.

Edinburgh Genome Foundry, University of Edinburgh

In the next decade, medical science may finally advance cures for some of the most complex diseases that plague humanity. Many diseases are caused by mutations in the human genome, which can either be inherited from our parents (such as in cystic fibrosis), or acquired during life, such as most types of cancer. For some of these conditions, medical researchers have identified the exact mutations that lead to disease; but in many more, they're still seeking answers. And without understanding the cause of a problem, it's pretty tough to find a cure.

We believe that a key enabling technology in this quest is a computer-aided design (CAD) program for genome editing, which our organization is launching this week at the Genome Project-write (GP-write) conference.

With this CAD program, medical researchers will be able to quickly design hundreds of different genomes with any combination of mutations and send the genetic code to a company that manufactures strings of DNA. Those fragments of synthesized DNA can then be sent to a foundry for assembly, and finally to a lab where the designed genomes can be tested in cells. Based on how the cells grow, researchers can use the CAD program to iterate with a new batch of redesigned genomes, sharing data for collaborative efforts. Enabling fast redesign of thousands of variants can only be achieved through automation; at that scale, researchers just might identify the combinations of mutations that are causing genetic diseases. This is the first critical R&D step toward finding cures.

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