vagus nerve stimulation

Posted on autoimmune conditions, Rheumatoid arthritis

Nerve stimulation promotes the resolution of inflammation

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The nervous system is known to communicate with the immune system and regulate inflammation in the body. Researchers at Karolinska Institutet in Sweden now show how the electrical activation of a specific nerve can promote healing in acute inflammation. The finding, which is published in the journal PNAS, opens new ways to accelerate the resolution of inflammation.

The way the body regulates inflammation is only partly understood. Previous research by Peder Olofsson’s group at Karolinska Institutet and other research groups has shown that electrical stimulation of the vagus nerve can reduce inflammation. Such nerve stimulation has been used with encouraging results in clinical studies of patients with inflammatory bowel disease and rheumatoid arthritis. However, how nerve signals regulate the active resolution of inflammation was unclear.

“We have now studied the effects of signals between nerves and immune cells at the molecular level,” says April S. Caravaca, a researcher in Peder Olofsson’s group at the Department of Medicine, Solna, Karolinska Institutet and the Stockholm Center for Bioelectronic Medicine at MedTechLabs. “A better understanding of these mechanisms will allow for more precise applications that harness the nervous system to regulate inflammation.”


The researchers showed that electrical stimulation of the vagus nerve in inflammation shifts the balance between inflammatory and specialised anti-inflammatory molecules, which promotes healing.

“Inflammation and its resolution play a key role in a wide range of common diseases, including autoimmune diseases and cardiovascular diseases,” says Peder Olofsson. “Our findings provide insights on how the nervous system can accelerate the resolution of inflammation by activating defined signalling pathways.”

The researchers will continue to study how nerves regulate the healing of inflammation in more detail.

“The vagus nerve is only one of many nerves that regulate the immune system. We will continue to map the networks of nerves that regulate inflammation at the molecular level and study how these signals are involved in disease development,” says Dr Olofsson. “We hope that this research will provide a better understanding of how pathological inflammation can resolve, and contribute to more effective treatments of the many inflammatory diseases, such as atherosclerosis and rheumatism.”

Posted on Rheumatoid arthritis

Study shows vagus nerve stimulation significantly reduces rheumatoid arthritis symptoms

What Is The Vagus Nerve? | The Art Of Living - YouTube


Clinical trial data published in the Proceedings of the National Academy of Sciences (PNAS) demonstrates stimulating the vagus nerve with an implantable bioelectronic device 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 findings, announced by the Academic Medical Center/University of Amsterdam, the Feinstein Institute for Medical Research and SetPoint Medical, appear online in PNAS Early Edition and will appear in an upcoming print issue.

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.

“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.”

“Our findings suggest a new approach to fighting diseases with bioelectronic medicines, which use electrical pulses to treat diseases currently treated with potent and relatively expensive drugs,” said Anthony Arnold, Chief Executive Officer of SetPoint Medical. “These results support our ongoing development of bioelectronic medicines designed to improve the lives of people suffering from chronic inflammatory diseases and give healthcare providers new and potentially safer treatment alternatives at a much lower total cost for the healthcare system.”

“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.”

While focused on rheumatoid arthritis, the trial’s results may have implications for patients suffering from other inflammatory diseases, including Crohn’s, Parkinson’s, Alzheimer’s and others.

Study Methodology and Results

In the study, a stimulation device was implanted on the vagus nerve during a surgical procedure, then activated and deactivated based on a set schedule to measure response over 84 days, with primary endpoints measured at day 42 using DAS28-CRP, a standard disease activity composite score for RA that includes counts of tender and swollen joints, patient’s and physician’s assessment of disease activity and serum C-reactive protein (CRP) levels.

Of 17 patients with active RA in the study, several patients that had failed to respond to multiple therapies, including biologicals with different mechanisms of action, demonstrated robust responses. The findings indicate that active electrical stimulation of the vagus nerve inhibits TNF production in RA patients and significantly attenuates RA disease severity.

Several patients reported significant improvements, including some who had previously failed to respond to any other form of pharmaceutical treatment. In addition, no serious adverse side effects were reported.

The emerging field of bioelectronic medicine aims to target disorders traditionally treated with drugs and instead uses advanced neuromodulation devices that may offer significant advantages. SetPoint is developing a novel proprietary bioelectronic medicine platform to treat a variety of immune-mediated inflammatory diseases, using an implanted device to stimulate the vagus nerve.

Posted on Autism

Vagus nerve stimulation study shows significant reduction in rheumatoid arthritis symptoms

Initial pilot data support the use of new neurostimulation treatment in a larger study in patients who have failed current standard of care

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The results of a pilot study presented at the Annual European Congress of Rheumatology suggest that electro stimulation of one of the nerves connecting the brain to the body (the vagus nerve), could provide a novel treatment approach for patients with rheumatoid arthritis.1

“This is a really exciting development. For many patients suffering from rheumatoid arthritis, current treatments don’t work, or aren’t tolerated,” said Professor Thomas Dörner, Chairperson of the Scientific Programme Committee, EULAR. “These results open the door to a novel approach to treating not only rheumatoid arthritis, but other chronic inflammatory diseases. This is certainly an area for further study.”

The vagus nerve is the longest and the most complex of the 12 pairs of cranial nerves that originate from the brain. The name ‘vagus’ comes from the latin word for ‘wandering’. This is because the vagus nerve wanders from the brain into the organs of the neck, chest and abdomen.

Recent advances in neuroscience and immunology have mapped circuits in the brain that regulate immune responses. In one of the circuits, the ‘inflammatory reflex’, signals are transmitted in the vagus nerve that inhibit the production of cytokines including tumor necrosis factor (TNF), an inflammatory molecule that is a major therapeutic target in rheumatoid arthritis. It is thought that, by stimulating the activity of this inflammatory reflex, innate immune responses can be modulated without abolishing them or producing significant immunosuppression.

In this pilot study, a novel miniaturised neurostimulator called a MicroRegulator was implanted into 14 patients with rheumatoid arthritis who had failed on at least two biologics or targeted oral therapies with different mechanisms of action. Patients were randomised to three groups who were either placebo, stimulated once daily, or stimulated four times a day for 12 weeks. At the end of the study, the patients who received once-daily stimulation were shown to have a better response than those on four-times-daily stimulation with two thirds meeting the EULAR good or moderate response criteria and a mean change in DAS28-CRP of -1.24. The mean change in DAS28-CRP* in the placebo group was 0.16.1

Cytokines (a broad and loose category of small proteins that are important in cell signalling) were also measured in the study with the actively stimulated groups showing a decrease of more than 30% in levels of Interleukin (IL) 1β, IL-6, and TNF-α. Implantation and stimulation were generally well tolerated with no device or treatment-related SAEs and two surgery-related adverse events that resolved without clinically significant effects.1

“Our pilot study suggests this novel MicroRegulator device is well tolerated and reduces signs and symptoms of rheumatoid arthritis,” said Mark Genovese, M.D., James W. Raitt Endowed Professor of Medicine, Stanford University, Stanford, California, USA. “These data support the study of this device in a larger placebo-controlled study as a novel treatment approach for rheumatoid arthritis and possibly other chronic inflammatory diseases.”

This study follows a proof-of-concept study which used reprogrammed epilepsy stimulators on the vagus nerve to demonstrate reduced systemic inflammation and improved disease activity in 17 patients with rheumatoid arthritis.3

The study included 14 patients with active rheumatoid arthritis who had had an insufficient response to more than two biological disease modifying anti-rheumatic drugs (bDMARDs) or JAK inhibitors with more than two modes of action. All patients remained on stable background of methotrexate. The first three patients were implanted and stimulated after three weeks, following safety review board approval, the remaining 11 patients were implanted and randomised to one minute of stimulation once-daily, one minute of stimulation four times daily, or one minute of placebo stimulation.1