Feinstein’s vagus research takes plenty of nerve

SetPoint MedicalFeinstein Center CEO Kevin Tracey is cofounder of SetPoint Medical, which uses electrical stimulation of the vagus nerve to treat everything from arthritis to congestive heart disease.

BY GREGORY ZELLER // What happens in vagus doesn’t actually stay there.

Or at least that’s the theory behind electrical stimulation of the vagus nerve, a long cranial bundle that extends from the brain to the abdomen. Medical science is just scratching the surface of the therapeutic value of vagus stimulation, but new studies suggest it goes far beyond the treatment of certain forms of epilepsy and depression, two longstanding targets of vagus manipulation.

Dr. Kevin Tracey, president and CEO of the Feinstein Institute for Medical Research and cofounder of California biotech firm SetPoint Medical, is heading research that stimulates the vagus with low-level electric pulses to treat arthritis, heart attacks, congestive heart failure and numerous other inflammatory conditions.

Tracey is credited with the discovery of what’s called the inflammatory reflex, the natural mechanism by which the central nervous system regulates the immune system. The SetPoint system uses a tiny pacemaker-like implant, a wireless charger and an app to deliver treatments.

Feinstein Center CEO Kevin Tracey

Feinstein Center CEO Kevin Tracey

In a just-published paper in the journal Bioelectric Medicine, Tracey notes that his colleagues at the Feinstein Institute – the R&D arm of the North Shore-LIJ Health System – have determined that stimulating certain vagus nerve bundles for as little as one-half of one millisecond activates the inflammatory reflux and inhibits the production of inflammation-inducing proteins released by the body’s cells.

And since repeated electrical pulses didn’t increase the therapeutic effectiveness in lab tests, according to Tracey, just one low-level, half-millisecond zap does the trick.

It’s a potential breakthrough of enormous therapeutic proportions, according to Yaakov Levine, SetPoint Medical’s senior research scientist.

“Seeing successful results with low-level electrical current is a significant finding,” Levine said in a written statement. “This indicates the potential for limited side effects as well as promise for device miniaturization, both of which will be important to bringing vagus nerve stimulation into the mainstream.”

Splashing into the mainstream is absolutely the goal here. Tracey is in constant contact with his California-based startup – “My lab and I communicate and collaborate with them regularly,” he told Innovate LI – which has already successfully tested vagus nerve stimulation as a rheumatoid arthritis treatment in humans. Now, SetPoint is looking forward to clinical studies for other diseases, Tracey said.

SetPoint isn’t the only company exploring the therapeutic benefits of vagus nerve stimulation. The therapy has been in popular practice as a treatment for epileptic seizures since the 1990s and has long been approved as a treatment in drug-resistant clinical depression cases.

A 2011 study published by researchers at the University of Texas showed suppression of tinnitus – commonly referred to as a “ringing” in the ear – in rats whose vagus nerves were stimulated with brief pulses, and clinical trials are underway in Belgium for human cases of tonal tinnitus.

It all makes for an exciting era in bioelectric medicine, which recruits bioengineering, neuroscience and molecular medicine on a mission to reduce inflammation. The race is on – though Tracey warned it will be some time before SetPoint Medical’s neuromodulation devices and other vagus nerve stimulation therapies become common anti-inflammatory treatments, at least in the United States.

“Because clinical studies are currently being conducted in Europe and not yet in the United States,” he said, “we are at least several years out before having a commercially available device on the U.S. market.”


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