Baptist Health Brain & Spine Care is Taking Part in U.S. Study of Nerve Stimulation Device to Treat Rheumatoid Arthritis

People suffering from moderate-to-severe rheumatoid arthritis manage their painful condition with medication that may produce negative side effects -- which is why there is a need for new and different treatments. A research team at Baptist Health Brain & Spine Care is participating in a clinical trial to test the effectiveness of a new device that stimulates the vagus nerve in patients with rheumatoid arthritis (RA).

The vagus nerve is the longest cranial nerve in the body, overseeing an array of crucial bodily functions, including control of mood, immune response, digestion, and heart rate. Researchers believe that when stimulated, the vagus nerve also plays a key role in reducing the inflammation linked to RA.

Justin Sporrer, M.D., director of functional neurosurgery at Baptist Health Miami Neuroscience Institute.

The study, named Vagus Nerve Stimulation for Moderate to Severe Rheumatoid Arthritis (RESET-RA), is a multi-institution trial that includes co-investigators Justin Sporrer, M.D., director of functional neurosurgery at Baptist Health Miami Neuroscience Institute, and Frank Vrionis, M.D., director of Marcus Neuroscience Institute at Boca Raton Regional Hospital, a part of Baptist Health.

The device that is the focus of the study on vagus nerve stimulation, or VNS, is called the SetPoint System.

Stimulating the vagus nerve to reduce inflammation is emerged as a possible alternative to current medication options, with one study conducted in Europe yielding promising results. VNS has been approved by the U.S. Food and Drug Administration for other conditions, such as epilepsy and depression. However, the vagus nerve remains an enigma. Researchers know it affects various parts of the body, though it isn’t entirely clear how it does so.

Frank Vrionis, M.D., director of Marcus Neuroscience Institute at Boca Raton Regional Hospital.

Currently, patients manage their RA with a range of available medications such as steroids, TNF inhibitors, biologics and disease-modifying agents.

“For several reasons, some people just won’t respond or respond inadequately to these medications,” said Dr. Sporrer. “Other people who maybe do get a good response can’t stand the side effects of existing medications, such as opportunistic infections that affect their quality of life.”

Prior research has shown that even small amounts of VNS can significantly reduce cytokine production.

Overproduction or inappropriate production of certain cytokines by the body can result in disease. Cytokines are proteins produced by cells in the body. Some are produced in excess in rheumatoid arthritis, where they're involved in inflammation and tissue destruction.

“The vagus nerve is a big mystery nerve. It controls a lot of bodily functions, such as the heart, stomach, bowels and so on,” said Dr. Vrionis. “The thinking behind this study is that stimulating the vagus nerve affects certain pathways in the body that contribute to the production of cytokines, which lead to inflammatory conditions like RA.”

During the study, Dr. Sporrer and Dr. Vrionis will implant the SetPoint System device for participants enrolled in South Florida. Half of the participants will have their devices turned on, while the other half will not (the control group). After 12 weeks, all participants will have their devices turned on and be followed for about six months to measure whether the device can help reduce inflammation.

“We’ve found that stimulating the vagus nerve for even 60 seconds at a time can create a cytokine-reducing effect that lasts anywhere from 24 to 48 hours,” said Dr. Sporrer.

Many existing VNS devices have two separate parts: a small coil that wraps around the nerve and an external battery connected to the coil that powers the device. However, these devices are complex to implant, and the external power source makes them relatively large.

“The SetPoint System is much smaller than current devices, about the size of a pill. And it includes an internal rechargeable battery instead of an external battery source,” says Dr. Sporrer. “These features make the device easier and quicker to implant.”

The study is currently enrolling, with plans to enroll about 250 patients with RA over the next two years. For more information, visit clinicaltrials.gov (NCT04539964) or https://reset-ra.study.