X-ray image of joint damage from rheumatoid arthritis (Camazine Scott, National Institutes of Health)
26 March 2018. A device sending electrical pulses through a main nerve pathway is starting a clinical trial to test the device in people with rheumatoid arthritis, an autoimmune disease affecting joints and surrounding tissue. The study is testing the safety and effectiveness of the device, made by SetPoint Medical in Valencia, California among a small group of participants with the disorder.
Rheumatoid arthritis is an autoimmune disease, where the immune system is tricked into attacking healthy cells, that leads to inflammation of joints — in wrists, fingers, feet, and ankles — and surrounding tissue, affecting some 1.3 million people in the U.S., making it the most prevalent autoimmune disease. In addition, a large proportion of people with the disease, as many as half, do not respond to biologic treatments, making other treatment options necessary, according to the company.
SetPoint’s system is an implanted device that stimulates the vagus nerve to treat autoimmune disorders. The vagus nerve pathway extends from the brain stem to the abdomen, connecting other major organs including the heart, esophagus, and lungs. Research by SetPoint’s scientific co-founder Kevin Tracey, now president of Feinstein Institute for Medical Research, revealed a neurophysical mechanism called inflammatory reflex that senses problems such as infections and inflammation. That reflex, says Tracey, sends signals through the nervous system, including the vagus nerve, affecting the different organs in its path. In the spleen, those signals are received by T-cells, white blood cells in the immune system, which in turn reduce production of proteins preventing inflammation, allowing inflammation-causing enzymes to operate unchecked.
The system made by SetPoint implants a device near the vagus nerve that sends electrical pulses along the nerve pathway to activate the inflammatory reflex, and thus restore production of proteins protecting against inflammation in the joints of people with rheumatoid arthritis. In a proof-of-concept study reported in 2016, Tracey and colleagues show most people using the device — 11 of 17 — produced fewer inflammatory enzymes, as well as experienced less inflammation in their joints. In addition, no severe adverse effects were reported.
The new clinical trial is enrolling 15 individuals, age 22 to 75 with rheumatoid arthritis who do not respond or are not able to tolerate available treatments. In the first part of the study, looking particularly at the system’s safety, 3 participants will test the device for 12 weeks, with stimulation to the vagus nerve 4 times a day. In the second part of the study, the remaining 12 participants will be implanted with a device, but be randomized to receive stimulation to the nerve 4 times a day from the SetPoint system, or no stimulation with a sham device. In both parts of the trial, researchers will look primarily for evidence of adverse events from any source, but also track occurrence of rheumatoid arthritis, evaluated by a series of standard assessment scales, as well as MRI images of participants’ hands.
In addition to Kevin Tracey, SetPoint Medical was founded by Shaw Warren, an inflammation and infectious disease specialist at Harvard Medical School, Massachusetts General Hospital, and Wyss Institute, a biomedical engineering center at Harvard. As reported by Science & Enterprise in 2013, SetPoint Medical was the first recipient of financing from a venture fund established by drug maker GlaxoSmithKline to back companies developing treatments harnessing the body’s electrical system.
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