A research team at Baptist Health, located in south Florida, is participating in a randomized-controlled, parallel-assignment clinical trial. This trial explores a new vagus nerve stimulation (VNS) device called the SetPoint System. The device is designed to treat moderate to severe rheumatoid arthritis (RA).
The study, named the Vagus Nerve Stimulation for Moderate to Severe Rheumatoid Arthritis (RESET-RA) study, 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.
Currently, patients manage their RA with medications such as steroids, TNF inhibitors, biologics and disease-modifying agents. However, not everyone responds to these medications. And those who do may also experience negative side effects, highlighting a need for new treatments.
“For several reasons, some people just won’t respond or respond inadequately to these medications. 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,” said Dr. Sporrer.
Stimulating the vagus nerve to reduce inflammation in the body has emerged as a possible alternative to current medication options, with one study conducted in Europe yielding promising results. VNS has even been FDA-approved 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 how isn’t entirely clear.
“The vagus nerve is a big mystery nerve. It controls a lot of bodily functions, such as the heart, stomach, bowels and so on. 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,” said Dr. Vrionis.
Prior research has shown that even a little bit of VNS can significantly reduce cytokine production.
“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.
Getting the best results, however, requires an effective VNS device. 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.”
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.
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