In September 2017, 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 in Vancouver. This clinical study on the benefits 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 concluded that non-invasive vagus nerve stimulation was a rapidly effective, well tolerated, and practical treatment for episodic migraine headaches. However, gammaCore has not yet been approved by the FDA for treatment of migraines. (I reported on these findings in a Psychology Today blog post “Non-Invasive Vagus Nerve Stimulation May Relieve Migraines.”)
Courtesy of BioSelf Technology
“Sensate” is a patent-pending, non-invasive vagus nerve stimulation device that is expected to be available to consumers sometime in 2018.Source: Courtesy of BioSelf Technology
As part of this timeline: In June 2017, a UK-based company, BioSelf Technology, unveiled another non-invasive vagus nerve stimulation gadget called “Sensate.” This palm-sized device is worn or placed close to the sternum and uses sub-audible sound waves to stimulate the vagus nerve.
Sensate triggers the “relaxation response” and lowers fight-or-flight stress responses in the autonomic nervous system.
Sensate users can also wear headphones and listen to auditory tracks that augment the sub-audible sound waves and guide brain activity towards specific frequencies. Binaural sounds heard through headphones can activate a parasympathetic vagus nerve response.
Sensate interfaces with a smartphone app that uses an algorithm to continuously monitor stress biomarkers and fine-tunes the device for optimal therapeutic response. This non-invasive VNS device is still patent pending and won’t be available for sale in the UK until sometime in 2018.
Stefan Chmelik is the founder and CEO of BioSelf Technology. He also directs the UK’s leading integrated healthcare center. In a statement, Chmelik said, “Stress has a huge and growing impact on the daily lives of people all over the world, and we have developed Sensate to directly combat the negative effect that it is having on society.”
Although more clinical studies are needed, the makers of the Sensate device say that more than 100 volunteers have used their pioneering gadget for 10-minutes per day over a six week period.
Based on changes in their heart rate variability (HRV), the researchers speculate that up to 86 percent of participants showed increased stress resiliency and parasympathetic vagus nerve activity.
Anecdotally, a freelance writer for the Daily Mail, Victoria Woodhall, recently tried a prototype of the Sensate device. She gave it glowing reviews.
“After ten minutes, I feel as rejuvenated as after a long hot bath. What I’ve just experienced is ‘vagal toning,’ a term that you’ll be hearing more and more. Looking back, 2017 was the year of gut health; 2018, however, is set to be the year that we’re all talking about the vagus nerve—the latest scientific weapon in the battle against stress.”
Earlier this year, the American Psychological Association published a “Stress in America: Coping With Change” annual report which identified the first significant uptick in anxiety levels since the survey began 10 years ago. In June 2017, the New York Times corroborated these finding in an article, “Prozac Nation Is Now the United States of Xanax,” which chronicles the epidemic of anxiety sweeping our nation.
Along this same line, in November 2017, the most recent “Stress in America: The State of Our Nation” report indicated that chronic stress is increasingly gnawing away at people’s sense of coherence. The latest APA survey found that 75 percent of Americans had experienced at least one symptom of acute stress in the month prior to the survey.
“Regular meditation is well-established as one of the most effective ways to self-manage stress, however, few people have the time to learn or practice this important skill,” Jacob Skinner, CTO of BioSelf Technology said in a statement. “Sensate provides a solution to the growing stress epidemic in a time-poor generation.”
For the record: I have no conflict of interest or affiliation with any of the aforementioned vagus nerve stimulation manufacturers. As always, I encourage people to seek gadget-free ways to improve vagal tone and vagus nerve function on a daily basis whenever possible. Nevertheless, the latest technological advances regarding implanted VNS devices and non-invasive vagus nerve stimulation gadgetry appear to have tremendous potential.
As mentioned earlier, more rigorous clinical research is needed to empirically support the stress-busting claims being made by Chmelik and Skinner. That said, based on what we know about the vagus nerve, there appears to be a very good chance that non-invasive VNS devices could be a game changer when it comes to tackling the global stress epidemic on a psychophysiological level.
Tracey, Kevin J. “The Inflammatory Reflex.” Nature (2002) DOI: 10.1038/nature01321
Koopman, Frieda A., Sangeeta S. Chavan, Sanda Miljko, Simeon Grazio, Sekib Sokolovic, P. Richard Schuurman, Ashesh D. Mehta, Yaakov A. Levineh, Michael Faltysh, Ralph Zitnikh, Kevin J. Tracey, and Paul P. Tak. “Vagus nerve stimulation inhibits cytokine production and attenuates disease severity in rheumatoid arthritis.” Proceedings of the National Academy of Sciences (2016) DOI: 10.1073/pnas.1605635113
Fight Or Flight
A fear of flying creates something of a problem when your job requires frequent international travel. Here, Vogue jewellery editor Carol Woolton attempts to overcome her misgivings once and for all.
By Carol Woolton
Friday 30 March 2018
Photo by Helmut Newton
Is it my paranoia or have there been more plane crashes than usual recently? For someone terrified of turbulence this was playing on my mind as I planned my flight to the Basel watch and jewellery fair this week. You see, I’ve had some scary flights to Basel over the years.
Once a pilot threatened that we were flying straight into the “eye of a storm”, another time a stewardess shouted over the tannoy system: “Sit down, this is a very dangerous flight” and with a thumping heart I imagined the entire British jewellery industry plummeting into the snow-capped Alps where we’d freeze to death before anyone could find us.
Mindful that I could be in for another nerve-racking flight I investigated a new stress-busting tool, which works in tandem with your smartphone. The smooth pebble shaped device called Sensate vibrates on the vagus nerve lying underneath your breast bone, which holds the key to keeping calm as it wends its way from the brain to the gut, controlling the rapid breath, increased heart rate and blood pressure of flight or flight responses.
The weather report at 5am was promising gale force winds over Western waters – I’ve no idea where those are exactly but I wasn’t taking any chances and grabbed the Sensate before heading to Heathrow.
to order go to Sensate: http://www.Getsensate.com
We all know fear of flying is unscientific and illogical, but the conscious mind doesn’t communicate this to the body to prevent it releasing stress hormones. On a flight to New York recently I eavesdropped as the pilot, who’d emerged from the cockpit, was reassuring the terrified woman seated behind me taking her first flight over 30 years. It was going to be choppy for the next couple of hours.
“Don’t be frightened it’s just the weather,” his calm voice said, “think of it as a boat bobbing up and down on the water in the wind”. I stopped listening; he’d pinpointed the reason for my nervousness. There are thousands of boats littering the seabed due to adverse weather conditions.
On board the Basel flight I take my aisle seat, having paid extra to move in case I needed a quick getaway, and they start the safety video, which the comedian Ricky Gervais described as “a bit of a downer” during his recent Humanity tour. “If you do go into the side of a mountain at 500 miles an hour,” he quipped, “the brace position does f*** all.”
I plug the Sensate into my phone, and the low-frequency sound waves begin to pulse gently through my chest, with the Forest music that I’d chosen from the app to channel through my earphones, and soon the combination distracts my mind. When the vagus nerve is activated apparently it puts the brakes on the stress response and I do begin to notice that I am feeling calmer than usual.
When the seat belts sign pings on, the plane shakes and rattles, and my exit is blocked by the drinks trolley (always a panicky moment), so I turn up the volume of the music and the vibration intensity on my phone. This small decision makes me imagine that I have some control over my anxiety and immediately I start to relax again.
“Our cross cultural instinct level is so intense,” explains integrated healthcare physician Stefan Chmelik, whose company Bioself Technology have developed Sensate, “But it’s primitive, like that of a 500 million-year-old lizard which goes into flight, fright or freeze mode.
The problem is that the brain stem is powerful, but not smart, and can’t differentiate between real and imagined threats.” Which means the same life or death response is applied for anything – even too many e-mails in your inbox is classed as a physical danger.
I arrive in Basel with a clearer mind and feeling more at ease than I have before, grateful that I didn’t succumb to gin and tonics like the nervous couple sitting in front of me as I glance in my diary at the daunting schedule of back-to-back meetings. My vagal toning may not be over quite yet.