Bioelectric Device Shows Promise for RA, Small Study Shows

Bioelectric Device Shows Promise for RA, Small Study Shows

By Staff

A small study published in the July issue of Proceedings of the National Academy of Sciences (PNAS), showed that the delivery of electrical stimulation to the vagus nerve significantly improved measures of disease activity in patients with rheumatoid arthritis (RA). RA is a chronic inflammatory disease that affects 1.3 million people in the United States and costs tens of billions of dollars annually to treat.

The publication, titled “Vagus nerve stimulation inhibits cytokine production and attenuates disease severity in rheumatoid arthritis,” highlights a human study designed to reduce symptoms of RA, cytokine levels and inflammation by stimulating the vagus nerve with a small implanted device, which manufacturer, SetPoint Medical, calls a bioelectric device.

Seventeen patients with RA participated in the study. Seven were in the early stages of RA and had not responded to methotrexate. The others had more advanced disease and no improvements after taking biologic drugs.

Six weeks after being implanted, most patients noted improvement with 71.4 percent having at least a 20 percent improvement in their symptoms. In the group with early-stage RA, 57.1 percent had at least a 50 percent improvement.  For the latter group with more advanced presentation of RA, 28.6 percent had at least a 50 percent improvement.

“This is the first study to evaluate whether stimulating the inflammatory reflex directly with an implanted electronic device can treat RA in humans,” said Professor Paul-Peter Tak, MD, PhD, FMedSci, the international principal investigator and lead author of the paper at the Division of Clinical Immunology & Rheumatology of the Academic Medical Center/University of Amsterdam.

“We have previously shown that targeting the inflammatory reflex may reduce inflammation in animal models and in vitro models of RA. The direct correlation between vagus nerve stimulation and the suppression of several key cytokines like TNF as well as reduced RA signs and symptoms demonstrates proof of mechanism, which might be relevant for other immune-mediated inflammatory diseases as well,” Dr. Tak added.

“This is a real breakthrough in our ability to help people suffering from inflammatory diseases,” said co-author Kevin J. Tracey, MD, president and CEO of the Feinstein Institute for Medical Research, discoverer of the inflammatory reflex and co-founder of SetPoint Medical.

“While we’ve previously studied animal models of inflammation, until now we had no proof that electrical stimulation of the vagus nerve can indeed inhibit cytokine production and reduce disease severity in humans. I believe this study will change the way we see modern medicine, helping us understand that our nerves can, with a little help, make the drugs that we need to help our body heal itself,” Dr. Tracey added.

The bioelectric device is surgically implanted in the body and delivers doses of electrical current to the vagus nerve.  These electrical signals that travel through the vagus nerve and splenic nerve trigger reduction in activation of T Cells and microphages in the spleen. This results in a reduced production of systemic inflammatory mediators and reduced activation of circulating immune cells.  The result is decreased inflammation, decreased joint damage and reduction in joint pain.

According to SetPoint Medical, co-founder Kevin Tracey and his colleagues discovered and characterized the Inflammatory Reflex, which is a neurophysiological mechanism that regulates the body’s immune system. The Inflammatory Reflex senses infection, tissue injury and inflammation and relays this information to the central nervous system, which then reflexively increases neural signaling peripherally through the vagus nerve and splenic nerve that extensively innervate the spleen and other visceral organs. The signal is transmitted to a novel population of T cells in the spleen, which in turn direct effector cells including monocytes and macrophages to reduce their production of the mediators that initiate and perpetuate inflammation.

Dr. Tracey published his findings in Nature in May 2000. Since then, the Inflammatory Reflex has been characterized by his group and others in more than 100 peer-reviewed papers in leading scientific journals, exploring the potential of activating the Inflammatory Reflex to alleviate inflammation.

The Wall Street Journal reports that SetPoint Medical plans broader human studies in the next six to nine months.

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Authored by: Staff

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Linda Shaw

I have Mixed Connective Tissue Disease which, for me, consists of RA, Sjogren’s, Scleroderma, Vasculitis, dermatomyositis, with “hands and feet” on fire neuropathy, pleurisy/serositis. I came into contact with an over the counter “tens” unit vendor at an RV fair a few months ago. I wasn’t much one for all the gatchets and “California grape-nut” therapies until the pain got so bad I was desperate enough to try anything. I have to say, this unit is the BOMB as an adjunct. It can be sooo gentle or it can act like a Thai woman jumping up and down on you. It literally moves your body as if you have an invisible masseuse standing behind you LOL. I would definitely stick with my electrode attachments vs invasive implant as long as I could. I like that I can move it from place to place too. It came with a lumbar pad and long belt, and two rubber flip flops to do your feet. High quality item, I’m not a sales rep just a happy customer :).

Tim Mason

Neuromodulation Market worth $6.20 Billion by 2020
So this is why everyone is trying to get people onboard with these things.
The major players are Medtronic, Boston Scientific, St. Jude Medical, Synapse Biomedical, Nevro Corporation, Neurosigma, Neuropace, Neuronetics, Cyberonics and BioControl Medical.
I can’t help but believe this is all about the money. If you look at the FDA medical device recalls you will find the recalled ones and a massive list of problems that you will not find in any of the brochures that I received from my doctor. I did not bite on the Low Frequency one so they gave me on HF 10 by Nevro.
There is simply not enough information available to make an informed decision to get one of these.
If you follow the link and read the article you will feel like you are being had!!
These things are nothing but a marketing scheme.
Oh sure these are the hottest thing since slice bread.
Only for those making the money.

Jean Price

How can we find out if these broader studies are available in our areas?! I have a lot of vagus nerve generated symptoms and this looks interesting! Of course with pain, if someone said the dust of moth wings would help if we put it in our ears…I would start searching for moths!! The human body is so complex, and we have so few answers in light of nutrition, nerve involvement, and hormonal responses..I often wonder if some small change could be dramatically effective. Invasive procedures are no ones’s first choice, yet if they have better than average results, I consider the alternatives…and there seems to be a shortage of those, except medications that alter so much body chemistry it’s anyone’s guess as to why or how they work!!

Tony Smith

My doctor keeps pushing this on me ( after having done 3 back surgeries on me)
98 percent of the people who get the implant have it taken out within a short period of time. The Doctor gets $60,000 to put it in with no gaurantee that it will work. My physiatrist is against it. If I need electrical stimulation I’ll use my tens unit and that will work just as well.. It’s more snake oil. I live everyday with severe and debilitating pain. I’m at a point now where I walk with a walker and shuffle my feet. There are far too many issues to list here.
I need my opioids to live. I’m not a junkie and don’t ever over do it with my pain medication. I live on SS/D and live in NYC.
I support my family and can not even enjoy my baby.
Where I live heroin is big, I’ve lost many people to that drug.i would not go near it. I can understand if they cut people off of their opioid where does the powers that be think these people who suffer CPS are going to go? I’d rather be dead than on heroin. Thanks for listening!

Chronic Pain Sufferer

I’d like to see a NON invasive option to surgically implanted device. I think more patients would be receptive to non invasive alternatives. Have any non-invasive alternates been effective and tested?


Hopefully this offers relief to some and hopefully it’s not forced upon pain patients who must try in order to continue to receive the medication that’s been proven effective. It’s a sad state of affairs when relatively new treatment options bring stress instead of relief for patients.

scott michaels

more snake oil.
I have a item that will reduce your pain, in some cases eliminate it. The thing is you must take it exactly as directed. If you dont you could get sick or even die if you take to much thinkink you will get high on it. This item has been proven to work already with millions of people. Its called opioid pain medication. ITS NOT BROKEN, THE PEOPLE THAT USE IT RECREATIONALLY ARE BROKEN. DONT BUY INTO THESE NEW BIOFEEDBACK ELECTRO WHOZITSWHATS. EVERY COMPANY IS TRYING TO MAKE MONEY ON OUR MISERY.

Jan Kane

Would this help neuropathy of feet (and hands)? It is so incredibly painful! I have an implanted SCS which is for back pain and is programed into one foot. Doesn’t really cover the neuropathy. Just wondered if they have considered multiple modalities?