A Hand-Held Device Is Helping COVID-19 Patients Breathe Again

Marshall Bedder, MD, FRCPC, was isolated in a hospital room with COVID-19 when he received the call in August. It was Peter Staats, MD, a fellow clinician scientist and an old colleague, calling to check in. Staats had no idea that Bedder was infected with the virus, or that he was struggling with severe shortness of breath despite receiving oxygen, steroids, and antivirals. So it was pure coincidence that a treatment Staats co-invented, gammaCore Sapphire CV, had just received Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA) to treat patients with COVID-19 and reduced airflow. Staats mailed his friend a device immediately. 

The next day, Bedder took the small, hand-held vagus nerve stimulator (VNS) and placed it on his neck. He stared at the pulse oximeter on his finger, its blinking numbers revealing a blood oxygen level of 91—quite a low number given the amount of supplemental oxygen he was receiving. He says he watched in awe as that number rose to 95 within minutes. For the first time since his diagnosis, Bedder was able to breathe. Three days later, he was discharged from the hospital. 

Bedder credits the device with saving his life.

“When you go into the hospital and they tell you’ve got bilateral COVID pneumonia, and they put you on oxygen, and nothing is helping, it’s very worrying,” Bedder, a clinical associate professor at the Medical College of Georgia, tells Verywell. “I think gammaCore was a very important part of my success in recovering from COVID. Not only did it make me feel better, but watching my stats go up like that gave me great hope and was just mind-blowing. It completely relieved my anxiety.” 

The gammaCore Sapphire CV was granted EUA in July for patients with suspected or confirmed COVID-19 who have asthma-related dyspnea (shortness of breath) and decreased airflow. It can be used at home or in a healthcare setting. However, the benefits of vagus nerve stimulation can extend far beyond the breath, and far beyond the acute phase of COVID-19. Research shows that VNS treatment can affect almost every organ, potentially easing more systemic and/or long-term COVID-19 symptoms. 

VNS and COVID-19

The gammaCore Sapphire CV sends electrical stimulation to the vagus nerve, which serves as the body’s command center and plays a crucial role in regulating signals throughout the body. 

Staats, the Chief Medical Officer of the National Spine and Pain Centers and the co-founder and Chief Medical Officer of electroCore, the company behind this device, tells Verywell that gammaCore was initially developed for and studied on asthmatic patients. That's why he immediately advocated for its use in COVID-19 treatment when New York was experiencing a shortage of ventilators last winter. 

“At the time, I knew three things: I knew we were running out of ventilators, I knew that this virus was going to completely swoop through the country, and I knew that we had already demonstrated we could safely improve breathing with our device,” Staats says.

Staats, who is a former president of the North American Neuromodulation Society, adds that the biggest benefit of this device may be its role in stopping the cytokine storm seen in severe COVID-19 cases. In a cytokine storm, a person’s immune system responds to the virus by going on overdrive and sending out a stream of inflammatory molecules that can lead to deteriorating conditions, organ damage, or death.

“It turns out that your body has to learn to recognize and fight off these foreign invaders, and the way that it does that is through an inflammatory response. However, sometimes that can go wrong," Staats says. "Think of a kid with a peanut allergy: You can give peanuts to a hundred people and have nothing happen, but if you give it to the wrong person, they get this unbelievably robust response.”

Staats says that because our body is able to create this response, it also has to have a mechanism to dampen it, which is what tapping into the vagus nerve can do. The vagus nerve trails down to the spleen, where inflammatory mediators are made. By stimulating the vagus nerve, you can block the production of these pro-inflammatory cytokines, Staats says. 

He isn't the first to suggest this. A 2016 study demonstrated that stimulating the vagus nerve can deregulate the production of pro-inflammatory cytokines in patients with rheumatoid arthritis (RA), an inflammatory-based autoimmune disease. Researchers achieved this using a surgical implant in the neck that sends out electrical impulses and quells the inflammation associated with RA. However, Staats and his team at electroCore are the first to create a non-invasive device that is able to influence the electrical language of nerves without requiring surgery. 

“The gammaCore modulates neurotransmitters involved in pain and modifies the ratio of parasympathetic versus sympathetic activity,” Staats says. “After you’ve had a production of these elevated cytokines, you can have pain and issues in blood flow and blood clotting. If there’s persistent inflammation, [the device] might be able to help some of the symptoms that people are experiencing, improving their quality of life and maybe even changing the direction and course of the disease.” 

How To Use the Device

According to the FDA Emergency Use Authorization letter, a user applies the gammaCore Sapphire CV over the vagus nerve by holding it against the skin of the side of the neck after applying the included conductive gel. Each treatment is two minutes long.

Patients can receive/administer themselves multiple treatments per day; the device is programmed to allow for up to 30 stimulations in a 24-hour period. However, the FDA says more than 24 stimulations per day has not been evaluated in controlled clinical trials.

Bedder says he used the gammaCore Sapphire CV a few times a day whenever he felt like he was struggling to breathe for about a week.

Treatment Potential for Long-Term COVID-19 

Before COVID-19, electroCore focused its efforts on a version of the device called the gammaCore Sapphire (not CV, which stands for "coronavirus"), which reduces and prevents pain from migraines and cluster headaches. While both the gammaCore Sapphire and the gammaCore Sapphire CV operate using the same frequencies and the same number of pulses, the former can be programmed for one to three years of use, while the latter can only be programmed for three months of use. After that, it dies. Staats says that three-month cutoff was a contingency of FDA clearance.

"The FDA wanted to be able to end the authorization when the pandemic ends," Staats says.

Still, even three months of use may benefit some patients with long-term COVID-19 who are unable to shed all their symptoms in the weeks after the virus clears.

Staats believes cytokine storm may be at least partially responsible for the symptoms of patients who develop long-term COVID-19 ("long-haulers").

“My hypothesis with long-haulers is that if your body is exposed to COVID-19, you can have persistent chronic infection and that can be manifested by cytokines," he says. "I’m not talking about having a virus still in your bloodstream or testing positive for antibodies, but about cytokines being continuously released."

In other words, long-haulers may be cleared of the virus and its antibodies, but not of the influx of cytokines caused by the virus.

"Since vagus nerve stimulation can broadly decrease cytokines, it might reduce long-haul symptoms,” Staats says. “For example, many long-haulers complain of headaches, and there’s a tremendous amount of data supporting gammaCore’s use for migraines, so that would actually be an on-label use of the original gammaCore device.”  

Previous studies for headaches and post-traumatic stress disorder have found an elevation of cytokines like Interleukin 6 and Tumor Necrosis Factor-alpha in both. Staats believes these are some of the pro-inflammatory cytokines involved with long-term COVID. 

“I suspect that some long-haulers may have continued local elevation in cytokines or continued sensitivity of nervous tissue that’s causing either headache, gastrointestinal symptoms, fatigue, airway symptoms, or neurological symptoms such as brain fog,” he says. 

The earlier this device is given in the course of treatment, the better. With COVID-19, Staats says halting inflammation immediately is essential and could potentially prevent post-viral complications. For Bedder, 65, it's been over two months since his recovery, and he has not exhibited any long-term COVID-19 symptoms.

Making a Case for a Hand-Held Treatment

Despite its EUA from the FDA, the gammaCore Sapphire CV has failed to capture medical and media attention like other treatments—including convalescent plasma or remdesivir. According to Bedder, who founded the North American Neuromodulation Society alongside Staats, that needs to change immediately. 

“I think when there’s a new treatment like this, hospital systems should be looking at it because it may be hard for individual doctors to order it and get it," Bedder says. "This should be in stock in all hospitals the same way oxygen and steroids are. You should have these devices on the shelf whether they be for asthmatics or COVID-19 patients."

The device is available with a prescription whether you use it at home or in a healthcare facility, and can be used for either suspected or confirmed cases of COVID-19. Staats says its covered by most insurance.

“This could actually save [insurance companies] a lot of money if it keeps people out of the ICU as it did me; it could save the system tens of thousands of dollars," Bedder says.

Diana Berrent, the founder of Survivor Corps, the largest grassroots movement for COVID-19 survivors, tells Verywell that the gammaCore Sapphire CV could have a tremendous impact on COVID-19 long-haulers like herself. 

“It blows my mind that this device hasn't gotten any attention—I only found out about it recently, and I said, ‘Surely there's a misunderstanding, this can’t exist, I would know about it,'' she says. "Decades ago, Peter Staats founded the pain department at Johns Hopkins University, and he has a lot of experience in the field of neuromodulation. He developed this and it really works. Long-haulers are looking for anything that people can use at home, and this can be it."

In the meantime, Staats and his team are collecting more data and running different studies on gammaCore’s efficacy in relieving the discomfort in multiple conditions. 

“I don’t have all the answers, but what I would say is that when I look at this, it's striking to me that not everybody in the world knows about gammaCore sapphire CV,” Staats says. “It’s the best-kept secret out there, and I’m trying my best not to keep it a secret.”

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