PTSD Treatment Receives Breakthrough Devices Designation


an illustration of a man in obvious distress

About one in 11 adults in the US will be diagnosed with Post-Traumatic Stress Disorder (PTSD), with about 8 million living with the condition.

PTSD might develop after a person experiences or witnesses traumatic events, and symptoms include chronic anxiety, intrusive memories, and trouble sleeping. 

Recent research showing success in repurposing an existing device to treat PTSD, led by an Emory-Georgia Institute of Technology team, was recently given a Food and Drug Administration (FDA) Breakthrough Devices Program designation. 

The pilot study involved non-invasive vagus nerve stimulation, and was conducted by J. Douglas Bremner, professor of psychiatry and radiation in Emory’s School of Medicine, and Omer Inan, chair of bioscience and bioengineering and associate professor in the School of Electrical and Computer Engineering at Georgia Tech. 

Vagus nerve stimulation already had FDA approval to treat neurological conditions such as epilepsy and depression by regulating brain response via an implanted device. 

Bremner and Inan believed that a commercially available device—a handheld stimulator called gammaCore used to treat migraines—could be used to also treat PTSD by reducing the physiological response to stress triggers. 

When held to the side of the neck along the vagus nerve, the device can “decrease sympathetic function and symptoms of PTSD,” says Bremner. 

This helps to reduce the “fight or flight” response and other symptoms of PTSD. 

“Research participants reported significant improvement in concentration,” says Bremner. 

The research team monitored study participants treated with the noninvasive vagus nerve stimulation (nVNS) device twice per day over three months, and the study yielded meaningful results, which were published in the Journal of Affective Disorders Reports. 

The authors concluded it was a “practical, safe, and novel treatment.”