Vagus nerve stimulation delivered with an implanted device has been shown to improve rheumatoid arthritis severity in early clinical trials.1 Could the future of rheumatoid arthritis treatment be electrical stimulation to regulate the body’s inflammatory reflex? Large-scale clinical trials are underway testing several kinds of novel electro-stimulatory implants. This device, worn behind the ear, delivers mild electrical stimulation to the vagus nerve for up to 30 minutes a day. The majority of the patients in the pilot study showed clinically significant improvements at the end of the 12-week trial. Almost one quarter of the cohort of 27 achieved disease remission by the end of the study. Future trials with a placebo group will be needed to validate these findings.
The vagus nerve runs from the brainstem down to the abdomen through the neck and chest and is a main channel for the communication of signals between the brain and the body. Research focused on how the vagus nerve mediates communication between has led to the development of small devices to suppress the appetite and treat depression.2 The vagus nerve also communicates with the brain when the body is experiencing inflammation and research suggests that the vagus nerve can act as a brake for the immune system, sending signals to the spleen slowing down its release of inflammatory molecules.
In a first in-human pilot study researchers from Stanford assessed the safety and effectiveness of a novel “mini” vagus nerve stimulation (VNS) device for the treatment of multidrug-refractory rheumatoid arthritis. The researchers reported no device-related or treatment-related adverse effects and the treatment reduced signs and symptoms of rheumatoid arthritis.3
A large confirmatory clinical trial has been initiated at 40 sites across the United States with the goal of recruiting 250 patients to whether vagus nerve stimulation can effectively treat rheumatoid arthritis. The device being tested in the trial is about the size of a vitamin tablet and it's surgically inserted through a small incision in the neck, and delivers low-voltage stimulations will be administered at night while patients are asleep. The implant is recharged wirelessly by wearing a small collar-like device for an hour each week. The trial is set to last around three years to account for long-term safety and efficacy data.
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