Effects of nVNS on brain and physiologyFDA Gives Breakthrough Device Status to nVNS for PTSD Doug Bremner Psychiatry January 15, 2022 Social MediaFacebook0Twitter0Pinterest0LinkedIn0 Effects of nVNS on peripheral heart and organ function and central brain function The Food and Drug Administration (FDA) on January 12, 2022, granted breakthrough status to the GammaCore non-invasive Vagal Nerve Stimulation (nVNS) device for posttraumatic stress disorder (PTSD). This was based on our study showing a 31% reduction in PTSD symptoms compared to a sham stimulation after three months of twice daily treatment. This was a joint project of Emory University and Georgia Tech. Transcutaneous cervical Vagus Nerve Stimulation (TCVNS) is an electrical stimulation applied to the neck where the vagus nerve courses through the carotid sheath. tcVNS reduces sympathetic and inflammatory function and thus has a beneficial effect on PTSD neurobiology. Effects of active (left) and sham (right) stimulation on PTSD symptoms. There was a 31% greater reduction in PTSD symptoms with active versus sham. Breakthrough designation allows the FDA to fast track approval for this condition which affects 8-10% of Americans at some time in their life.