{"id":1860,"date":"2022-01-15T13:29:43","date_gmt":"2022-01-15T18:29:43","guid":{"rendered":"https:\/\/beforeyoutakethatpill.com\/blog\/?p=1860"},"modified":"2022-01-22T17:56:28","modified_gmt":"2022-01-22T22:56:28","slug":"fda-gives-breakthrough-device-status-to-nvns-for-ptsd","status":"publish","type":"post","link":"https:\/\/beforeyoutakethatpill.com\/blog\/2022\/01\/15\/fda-gives-breakthrough-device-status-to-nvns-for-ptsd\/","title":{"rendered":"FDA Gives Breakthrough Device Status to nVNS for PTSD"},"content":{"rendered":"\n<figure class=\"wp-block-image size-large\"><a href=\"https:\/\/beforeyoutakethatpill.com\/blog\/wp-content\/uploads\/2022\/01\/brain_network2.png\"><img decoding=\"async\" width=\"972\" height=\"1024\" src=\"https:\/\/beforeyoutakethatpill.com\/blog\/wp-content\/uploads\/2022\/01\/brain_network2-972x1024.png\" alt=\"\" class=\"wp-image-1861\" srcset=\"https:\/\/beforeyoutakethatpill.com\/blog\/wp-content\/uploads\/2022\/01\/brain_network2-972x1024.png 972w, https:\/\/beforeyoutakethatpill.com\/blog\/wp-content\/uploads\/2022\/01\/brain_network2-285x300.png 285w, https:\/\/beforeyoutakethatpill.com\/blog\/wp-content\/uploads\/2022\/01\/brain_network2-768x809.png 768w, https:\/\/beforeyoutakethatpill.com\/blog\/wp-content\/uploads\/2022\/01\/brain_network2-1457x1536.png 1457w, https:\/\/beforeyoutakethatpill.com\/blog\/wp-content\/uploads\/2022\/01\/brain_network2-1943x2048.png 1943w, https:\/\/beforeyoutakethatpill.com\/blog\/wp-content\/uploads\/2022\/01\/brain_network2-750x791.png 750w, https:\/\/beforeyoutakethatpill.com\/blog\/wp-content\/uploads\/2022\/01\/brain_network2-1200x1265.png 1200w\" sizes=\"(max-width: 972px) 100vw, 972px\" \/><\/a><figcaption>Effects of nVNS on peripheral heart and organ function and central brain function<\/figcaption><\/figure>\n\n\n\n<p>The Food and Drug Administration (FDA) on January 12, 2022,<a rel=\"noreferrer noopener\" href=\"https:\/\/research.gatech.edu\/gammacoretm-non-invasive-vagus-nerve-stimulation-nvns-receives-breakthrough-device-designation\" target=\"_blank\"> granted breakthrough stat<\/a>us to the <a rel=\"noreferrer noopener\" href=\"https:\/\/www.healio.com\/news\/psychiatry\/20220114\/fda-grants-breakthrough-designation-for-device-to-treat-ptsd\" target=\"_blank\">GammaCore non-invasive Vagal Nerve Stimulation (nVNS) device<\/a> for posttraumatic stress disorder (PTSD). This was based on our <a rel=\"noreferrer noopener\" href=\"https:\/\/www.sciencedirect.com\/science\/article\/pii\/S2666915321001165\" target=\"_blank\">study<\/a> 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 <a href=\"https:\/\/www.healio.com\/news\/psychiatry\/20220114\/fda-grants-breakthrough-designation-for-device-to-treat-ptsd\" target=\"_blank\" rel=\"noreferrer noopener\">Emory University<\/a> and Georgia Tech.<\/p>\n\n\n\n\n\n<p>tcVNS reduces sympathetic and inflammatory function and thus has a beneficial effect on PTSD neurobiology.<\/p>\n\n\n\n\n\n<p>Breakthrough designation allows the FDA to fast track approval for this condition which affects 8-10% of Americans at some time in their life. <\/p>\n","protected":false},"excerpt":{"rendered":"<p>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. tcVNS reduces sympathetic and inflammatory function and thus has a beneficial effect on PTSD neurobiology. Breakthrough designation [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":1861,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"om_disable_all_campaigns":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[314,446],"tags":[580,183,40,591,590,264,579,581,589,54,171,173,578],"class_list":["post-1860","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-psychiatry","category-ptsd","tag-breakthough-device-designation","tag-depression","tag-doug-bremner","tag-emory-brain-health","tag-emory-university","tag-fda","tag-gammacore","tag-georgia-tech","tag-omer-inan","tag-psychological-trauma","tag-ptsd","tag-stress","tag-tcvns"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/beforeyoutakethatpill.com\/blog\/wp-json\/wp\/v2\/posts\/1860","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/beforeyoutakethatpill.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/beforeyoutakethatpill.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/beforeyoutakethatpill.com\/blog\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/beforeyoutakethatpill.com\/blog\/wp-json\/wp\/v2\/comments?post=1860"}],"version-history":[{"count":3,"href":"https:\/\/beforeyoutakethatpill.com\/blog\/wp-json\/wp\/v2\/posts\/1860\/revisions"}],"predecessor-version":[{"id":1879,"href":"https:\/\/beforeyoutakethatpill.com\/blog\/wp-json\/wp\/v2\/posts\/1860\/revisions\/1879"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/beforeyoutakethatpill.com\/blog\/wp-json\/wp\/v2\/media\/1861"}],"wp:attachment":[{"href":"https:\/\/beforeyoutakethatpill.com\/blog\/wp-json\/wp\/v2\/media?parent=1860"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/beforeyoutakethatpill.com\/blog\/wp-json\/wp\/v2\/categories?post=1860"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/beforeyoutakethatpill.com\/blog\/wp-json\/wp\/v2\/tags?post=1860"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}