Document Type

Conference Proceeding

Publication Date


Publication Title

Ann Rheum Dis


Background: An urgent need exists for differentiated RA therapies that are safer and cost-effective to expand treatment approaches for non-responders to disease-modifying anti-rheumatic drugs (DMARDs). Electrical stimulation of the vagus nerve activates the inflammatory reflex and has been shown to inhibit the production and release of inflammatory cytokines and decrease clinical signs and symptoms in chronic inflammatory diseases, including rheumatoid arthritis [1]. Objectives: The RESET-RA Study (NCT04539964) was designed to determine the safety and efficacy of a novel neuroimmune modulation device for treating rheumatoid arthritis. Presented here are data on the safety of the surgical implantation and use of this device in the first 60 human subjects enrolled in the study. Methods: The RESET-RA study is a randomized, double-blind, sham-controlled, multi-center, two-stage pivotal study to evaluate the safety and efficacy of a novel neuroimmune modulation device in patients with moderate-to-severe RA who are incomplete responders or are intolerant to one or more biologic or targeted synthetic DMARDs. The device system (SetPoint Medical, Valencia, CA) consists of 2 implanted components: a miniature, rechargeable, leadless pulse generator that is surgically implanted in the neck on the left vagus nerve and a silicon sleeve referred to as a positioning and orientation device (POD) that holds the generator in close approximation to the nerve; and two external components: a wireless charger and an iPad application for programming the pulse generation. All subjects were implanted with the study device. One to three weeks after the implant procedure, subjects were randomly assigned (1:1) to receive either active or sham stimulation (control). The safety of the surgical procedure, device, and device stimulation was blindly assessed after 12 weeks of stimulation therapy. Results: All device implant procedures were completed with no intraoperative complications, infections, or surgical revisions. No unanticipated adverse events (AEs) were reported during the perioperative period and at the end of 12 weeks of follow-up. No study discontinuations were due to AEs, and no subjects died during the study. There were no serious AEs related to the device, stimulation, or explant procedures. There were two serious AEs related to the implant procedure: vocal cord paresis and prolonged hoarseness were reported in two subjects and are known risks of implanting a device on the vagus nerve. The vocal cord paresis resolved following vocal cord augmentation with injectable filler and speech therapy; the other SAE is ongoing and improving with speech therapy. Conclusion: Initial results demonstrated that implantation and programming of the novel neuroimmune modulation device was safe, and the surgical procedure and device were well tolerated. Full results from this study, including the clinical efficacy, will be presented after the study is fully enrolled and data is analyzed to determine potential of neuroimmune modulation for treating rheumatoid arthritis.

PubMed ID

Not assigned.



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