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A Coin Size Neuromodulation Device Prevent Symptoms of Rheumatoid Arthritis

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According to a clinical trial results published in Proceeding of National Academy of Science (PNAS) stimulation of vagus nerve by an implantable bioelectronic device significantly reduced the symptoms of rheumatoid arthritis (RA) in patients and could be an alternative to costly immunosuppressive drugs.

SetPoint Medical IncTeam of Researchers from Academic Medical Centre, University of Amsterdam jointly with New York based Feinstein Institute for Medical Research and SetPoint Medical Inc. evaluated whether stimulation of inflammatory reflex by an implanted electronic device can reduce the symptoms of RA in patients.

inflammatory reflex

Figure 1. The Inflammatory Reflex (photo credit: SetPoint Medical).

This was the first-of-its-kind, human study designed to evaluate the inflammatory reflex after implantation of the bio-electronic device. The minimal non-invasive device was designed to stimulate the vagus nerve which in turn reduces RA symptoms, cytokine level and thereby reduces inflammation.

The tiny coin sized gadget works by giving electric shocks (4 times daily) which prevent the initial symptoms and slows the damage that can result in long term complications.

setpoint neuromodulation device

Figure 2. Neuromodulation for Inflammation (photo credit: SetPoint Medical).

The work started when co-author Kevin J. Tracey, MD, president and CEO of the Feinstein Institute for Medical Research, discovered the inflammatory reflex pathway and published his findings. Since then the trials have been demonstrated in multiple animal models and finally on humans.

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. “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.”

 

Methodology

A coin sized bio-electronic stimulation device was implanted in the vagus nerve through surgical procedure. The stimulation response of the device was evaluated for 84 days in a set schedule of activation and deactivation. The end point was measured in Day 42 using DAS28-CRP. DAS28-CRP is a standard measurement procedure of giving score for RA by counting of tender and swollen joints by the assessment of the disease activity by patient’s and physician’s serum C-reactive protein (CRP) levels.

 

Results

According to the researchers, results obtained showed positive and robust responses. In the study, out of 17 patients suffering from active RA showed positive response that the other medical procedures and multiple therapies including biologicals with different mechanisms failed to do. The findings thus revealed that the stimulation of vagus nerve inhibit the production of cytokine- TNF in RA patients thus decreasing the symptoms and reducing the effect of RA. The best part of the relatively low cost device is that the adverse effect was found to be negligible and few.

This novel and innovative technique not only reported significant improvements in the patients suffering from RA better than any other pharmaceutical treatments but it may also have implications and use in the treatment of other inflammatory diseases Crohn’s, Parkinson’s, Alzheimer’s.

Rheumatoid arthritis is an autoimmune chronic inflammatory disease characterized by severe synovial inflammation in the muscular joints resulting in degradation of bones and cartilage thus severely impacting day to day life of the patients and decreasing their life span. Several millions of dollars are spent treating this disease without any significant improvements in the adults.

This low cost, small, coin sized device definitely brought hope for millions of patients who were spending their money on various therapies without any relief and opened a whole new different level of treatment.

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.”

Featured image credit: Human Bone Structure Diagram © kentoh (Stock Photo ID: 125588201)

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