If you live in Denver, Colorado (or anywhere), and have rheumatoid arthritis (RA), you know how frustrating and painful it is when medicines don’t work—or when you have to live with the side effects, including high infection risk. There’s exciting news: the U.S. Food & Drug Administration (FDA) recently approved vagus nerve stimulation (VNS) as a new treatment for rheumatoid arthritis.
At Neurosurgery One, we have performed thousands of VNS procedures to treat people with epilepsy with high success rates and very low risks. We are now performing the procedure to treat patients with rheumatoid arthritis and treatment-resistant depression. I am also working with the stroke team at AdventHealth Porter to develop the protocol for using VNS for patients to make further improvements after immediate post-stroke rehabilitation has plateaued.
If you’re interested in learning more about this new treatment for rheumatoid arthritis, I’ve put together this guide in everyday language: what VNS is, how it works to treat rheumatoid arthritis, how well it works, who might be a candidate, plus benefits and risks.
If you’d like to talk to someone about whether this is right for you, please call our main number at 720-638-7500. At Neurosurgery One, we have neurosurgeons throughout the Denver metro area who perform VNS and physician assistants with VNS expertise who are happy to answer your questions.
What is vagus nerve stimulation?
The vagus nerve is a long nerve that starts in your brain and runs down through your neck and chest. It’s part of your nervous system that helps control things like heart rate, and digestion. It also plays an important role in your immune response, which is how your body fights disease or handles inflammation—and this is key when it comes to treating rheumatoid arthritis.
Vagus nerve stimulation (VNS) uses a small implanted device to deliver small electrical signals to the vagus nerve to change how it works — in this case, to reduce inflammation. VNS is not new. It was approved in the US in 1997 and has been used since that time to treat epilepsy. It is also approved to be used in patients with whose depression isn’t helped with medications.
In recent years, scientists have been studying its use in autoimmune or inflammatory diseases, including RA. The FDA approval is the first time a device has been cleared specifically for treating RA via the neuroimmune modulation pathway.
How does VNS treat rheumatoid arthritis?
RA is a disease where your immune system is overactive and attacks joint tissues, causing swelling, pain, stiffness, and eventually joint damage. Traditional treatments often use drugs that suppress parts of the immune system. These can be biologic drugs or targeted synthetic disease-modifying antirheumatic drugs (DMARDs).
VNS works differently:
- When the vagus nerve is stimulated, it acts through the inflammatory reflex to release signals that help reduce the release of molecules that cause inflammation and drive much of the joint damage. Two primary pro-inflammatory chemicals affected are TNF (Tumor Necrosis Factor) and IL-6.
- Instead of suppressing the entire immune system, which can leave you vulnerable to infections, VNS helps your immune system to “reset” or calm down the parts that are too active.
In simpler terms, we’re using your nervous system to turn down the inflammation that causes RA.
How is vagus nerve stimulation for rheumatoid arthritis performed?
Vagus nerve stimulation (VNS) is a fairly simple procedure. If medications have been failing to control your pain or are causing intolerable side effects, we will work with your rheumatologist to determine if you are a good candidate for VNS. This procedure is a minimally invasive procedure that is often performed as an outpatient procedure, meaning you will go home the same day.
During the procedure, we will:
- Insert a one-inch device through your neck and place it in a pod that is wrapped around your vagus nerve.
- Once the device is in place, we program it for how often it will stimulate the nerve. Typically, the device will stimulate your vagus nerve for about one minute every day. However, the device can be tuned to your needs and re-adjusted without further surgery.
- Your rheumatologist or primary care provider will do a blood test periodically to track the level of inflammatory markers. Your provider also will monitor you level of joint pain and swelling and any side effects from the procedure.
How well does VNS for RA work?
What we know so far is promising. In a clinical study known as the RESET-AR trial, 240 patients with moderate to severe RA that was not controlled by medication were followed after having VNS. The results included
- At 3 months, many participants reported at least a 20% improvement in symptoms.
- Joint swelling and pain reduction continued to improve through 12 months, with some participants able to reduce or stop medications.
- The VNS device was generally well tolerated, with only 1.7% of participants reporting serious side effects.
VNS isn’t right for every patient with rheumatoid arthritis, but it can provide significant relief to people whose RA is not responding to medications.
Who is a candidate for VNS for rheumatoid arthritis?
You might be a candidate for VNS if:
- You are an adult with moderate to severely active rheumatoid arthritis. That means your RA is causing enough symptoms (pain, swelling, joint damage risk) that simpler treatments aren’t enough.
- You have already tried one or more biologic or targeted synthetic DMARDs, and those either didn’t work well enough, stopped working, you couldn’t tolerate them, or they put you at high risk for significant infections.
- You have not had a previous surgery to cut part of your vagus nerve (a procedure called vagotomy) or to remove your spleen.
- You do not have a medical condition that makes surgery risky.
What are the benefits and risks of VNS for rheumatoid arthritis?
In my opinion, the benefits of this procedure IF you are an appropriate candidate far outweigh the risks, especially since VNS is not new.
The benefits include:
- Reduced pain, swelling, stiffness, and improved joint function
- Potential to reduce or stop RA medications
- Reduction in immune suppression, which can lower the risk for viruses and infections
- Improved mobility and ability to take part in daily activities
Risks / Side Effects:
VNS is a minimally invasive procedure that uses very small incisions to place the implant. The most common side effect is hoarseness of voice that typically goes away within a few days or weeks. Some people notice their voice gets hoarse during the stimulation, which is usually just for 1 minute a day.
Risks associated with the procedure are very low but include pain and bruising at the incision site, and, very rarely, nerve or nerve-adjacent tissue injury. The biggest serious risk is surgical site infection, but that is very rare. In fact, I surveyed my 10 neurosurgeon partners and among us, we can only recall one case of an infection and it was with a patient who had their initial procedure performed elsewhere.
However, it’s important to note that while VNS has been around for 30 years, its use in treating RA is new so we don’t yet have long-term data. We are still learning exactly how long the effects last, or if there are very late complications.
Should I consider VNS for my rheumatoid arthritis?
If you have rheumatoid arthritis in Denver, Colorado, or elsewhere, and standard treatments aren’t fully helping, vagus nerve stimulation may be a promising new treatment for rheumatoid arthritis. It offers a different approach—using the body’s nerve and immune system to reduce inflammation — rather than relying only on strong immune-suppressing drugs.
At Neurosurgery One, we believe in staying up to date with these advances. If you think VNS might be right for you, talk to your rheumatologist or call us directly to assess if you’re a candidate. We can help you weigh benefits, risks, and whether this device could help you live more comfortably and freely.
