A pilot study for a post-traumatic stress disorder (PTSD) therapeutic device—the non-invasive vagus nerve stimulation (nVNS)—was recently published, which supports its recent Breakthrough Device designation from the U.S. FDA.
The pilot study—from Georgia Tech researcher Omer Inan and Emory University psychiatrist Douglas Bremner—opens the door to a hopeful new therapeutic alternative for people suffering from PTSD. PTSD affects about 15 million adults in the U.S. each year. And more than half of the people with PTSD are left with a severely impaired quality of life. It’s a disabling psychiatric disorder with few treatment options.
Their work, published in December’s Journal of Affective Disorders Reports, supports the recent Breakthrough Device designation from the FDA for a new treatment for PTSD.
“The concept was to see if this commercially available stimulation device could be used to reduce the physiological response to the stress triggers that PTSD patients encounter,” says Inan, the Linda J. and Mark C. Smith Chair in Bioscience and Bioengineering and associate professor in the School of Electrical and Computer Engineering. “And our results were very encouraging – they suggest that this is a practical, safe, and novel treatment.”
The researchers demonstrated that a handheld nVNS device called gammaCore—made by bioelectronics company electroCore and typically used to treat migraines—reduced PTSD symptoms significantly when compared to a placebo simulation.
The research results were found to be sufficiently compelling by the FDA to accelerate gammaCore’s use as a treatment for PTSD through the Breakthrough Device Program, which speeds the development of medical devices for the more effective treatment of life-threatening or irreversibly debilitating conditions.
For the PTSD treatment pilot study, Inan’s lab used its noninvasive tech to focus on cardiovascular signatures, “that relate to the level of flight or flight response, measurements that change significantly with vagus nerve stimulation, which we just didn’t know before,” he says.
The foundation for this work, Inan added, began with funding from the Defense Advanced Research Projects Agency, DARPA, “which set the scientific premise for why this device could work in patients with PTSD,” he says.
That was several years ago, and it set Inan on a search for clinicians at Emory who were researching PTSD. And that’s how he found Bremner, former director of the Yale Trauma Research Program and current director of the Emory Neuroscience Research Unit.
Featured image: Georgia Tech researcher Omer Inan. Photo Allison Carter
