Long Island scientists collaborating with an international team of investigators have proved that rheumatoid arthritis — a chronic, progressive, debilitating and inflammatory disease — can be controlled with an implantable bioelectronic device.
The stunning results from a small clinical trial of 17 patients involved a device about the size of a cardiac pacemaker that was implanted along the vagus nerve, which interfaces with the heart, lungs and upper digestive tract, among other organs, said Dr. Kevin Tracey, director, president and chief executive of the Feinstein Institute for Medical Research in Manhasset. The institute is a division of the Northwell Health system.
Tracey said this non-pharmaceutical approach to rheumatoid arthritis is a medical milestone and a dramatic first in the emerging science of bioelectric medicine.
“We discovered how the brain controls the immune system through reflex,” said Tracey, a neurosurgeon and scientific medical investigator. “There’s no argument the brain controls the heart and the gut through reflexes. This is the first clinical trial to target what we call the inflammatory reflex.”
He and his colleagues demonstrated that electrical stimulation inhibited the powerful forces of inflammation, including the signaling molecules known as cytokines, infinitesimal hormonelike proteins that play a key role in rheumatoid arthritis.
Dr. Paul-Peter Tak, Tracey’s colleague at the Academic Medical Center/University of Amsterdam in the capital of the Netherlands, also underscored that the work breaks new scientific ground and raises new hope as a treatment for rheumatoid arthritis.
“This is the first study to evaluate whether stimulating the inflammatory reflex directly with an implanted electronic device can treat RA in humans,” said Tak, the international principal investigator, in a statement Thursday.
“We have previously shown that targeting the inflammatory reflex may reduce inflammation in animal models and in vitro models,” Tak said of laboratory investigations.
He and Tracey noted the direct correlation between vagus nerve stimulation that caused the suppression of several key populations of molecules that drive the disease. Electrical stimulation reduced rheumatoid arthritis symptoms in 12 of the 17 patients in the study. The achievement stands as a proof of principle, the researchers said Thursday.
Details of their research are reported in the current issue of the Proceedings of the National Academy of Sciences.
SetPoint Medical, a Southern California maker of neurostimulation devices, provided the “off-the-shelf” device used in the research. Tracey said the device was reprogrammed to specifically address the biological forces driving rheumatoid arthritis.
Anthony Arnold, chief executive of SetPoint, said the findings strongly advance the potential of fighting diseases with “bioelectronic medicines.”
“These results support our ongoing development of bioelectronic medicines designed to improve the lives of people suffering from chronic inflammatory diseases and give health care providers new and potentially safer treatment alternatives at a much lower total cost for the health care system,” Arnold said.
The stimulatory impulses target the vagus nerve pathway in the spleen, a repository for immune system cells, such as T and B cells, and a host of other immune system factors, Tracey explained Thursday.