Inflammation is at the root of so many chronic diseases: cancer, heart disease, Alzheimer's, Parkinson's, diabetes and obesity — not to mention myriad potentially debilitating autoimmune diseases such as rheumatoid arthritis, multiple sclerosis and inflammatory bowel diseases. A computer chip implanted in the neck may be all that stands between patients with these diseases and a lifetime of relief.
Twenty-five years ago, Kevin Tracey, MD, President and CEO of Feinstein Institutes for Medical Research at Northwell Health, discovered a new biological pathway called the "inflammatory reflex." This advance ushered in the era of vagus nerve stimulation to treat chronic inflammation. The inflammatory reflex signals along the vagus nerve, which has a large role in the autonomic nervous system controlling involuntary body functions including maintaining homeostasis of the immune system.
Tracey co-founded SetPoint Medical, the manufacturer of a tiny vagus nerve stimulation device driven by a programmable computer chip. Clinical trials have shown that the device can relieve symptoms in people with chronic inflammatory diseases. The FDA is reviewing the device for potential approval.
Cure spoke with Tracey about his invention and its promise to relieve inflammation, improve quality of life for those with chronic conditions…and, maybe, even enable people to live longer.
This interview has been edited for length and clarity.
Cure: How did you discover that the vagus nerve is involved in regulating inflammation?
Tracey: Some years ago, my colleagues and I discovered that the brain can turn off inflammation in the body. In the lab, we noticed that putting a particular molecule in the brains of mice and rats stopped inflammation in those animals. We also observed that if you electronically stimulated the vagus nerve, it stopped inflammation.
There's a critically important group of nerve fibers in the neck that turn off inflammation, and we learned we could control those fibers with a computer chip. I knew if we could stop the production of [inflammatory] cytokines like TNF and IL-1, we should be able to treat diseases like rheumatoid arthritis and Crohn's disease.
Cure: How does the device work?
Tracey: The device is a vagus nerve stimulator that contains a computer chip and delivers an electric current to the vagus nerve. It is about the size of a Tylenol capsule.
During an outpatient surgical procedure of about a half hour, the surgeon makes a small 1.5-inch incision in the left side of the neck and places the capsule next to the carotid artery.
Cure: How is the device controlled?
Tracey: The doctor controls the activity of the vagus nerve stimulator via an iPad. The patient comes to the doctor in the office every six to eight weeks to have the settings adjusted.
We have found that just a minute or so a day of nerve stimulation is sufficient to alleviate symptoms in most patients. Patients recharge the device at their convenience using a wireless charger.
Cure: What have you learned from clinical trials assessing this device?
Tracey: The initial clinical trials were performed in Europe in people with rheumatoid arthritis and Crohn's disease. The [phase 3] RESET-RA clinical trial in the United States is assessing the safety and efficacy of the device to treat adults with active moderate to severe rheumatoid arthritis who have had an inadequate response or intolerance to disease-modifying drugs. Some people have experienced relief of symptoms that enabled them to stop taking their drugs. Others have had better clinical responses when they combined their drug therapies with the device. Some people didn't respond. These early results are really striking and important.
We hope this will lead to approval by the FDA in the coming months to treat patients with debilitating rheumatoid arthritis. The FDA has granted us a Breakthrough designation for this indication. They also gave us a Breakthrough designation to perform clinical trials of the device in people with multiple sclerosis.
[SetPoint Medical announced late-breaking data from the RESET-RA study at the American College of Rheumatology Convergence 2024 meeting on Nov. 18, 2024. The new positive data demonstrated promising clinical benefits of the neuroimmune modulation platform among certain adults living with moderate-to-severe rheumatoid arthritis through 24-week follow-up.]
Cure: Two indications now — rheumatoid arthritis and multiple sclerosis — that's exciting!
Tracey: Yes, it is! If you're debilitated by or at risk of death from an inflammatory condition, do you continue taking expensive drugs with side effects, or do you try a 30-minute outpatient procedure that provides a lifetime of therapy? I know what I'd sign up for.
Cure: What does the word "cure" mean to you?
Tracey: "Cure" is a word that doctors don't use or tend almost never to use. But when I see patients today who've spent sometimes half of their adult life on powerful medications that did not alleviate their symptoms — who are now walking around with a computer chip in their neck, taking no medications, having no symptoms and living a normal full life — that's my new definition of a cure
