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electroCore Announces Department of Veterans Affairs Sponsored Study of Non-Invasive Vagal Nerve Stimulation (nVNS) in Mild Traumatic Brain Injury (mTBI) and Post-Traumatic Stress Disorder (PTSD)
BASKING RIDGE, N.J., Sept. 30, 2020 (GLOBE NEWSWIRE) -- electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced
About this update from Electrocore, Inc.
[{"type":"text","content":"BASKING RIDGE, N.J., Sept. 30, 2020 (GLOBE NEWSWIRE) -- electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced that the Department of Veterans Affairs has agreed to sponsor a quadruple blind, randomized, sham-controlled clinical trial of non-invasive vagal nerve stimulation (nVNS) in mild traumatic brain injury (mTBI) and Post-Traumatic Stress Disorder (PTSD). The trial is being sponsored by the Department of Veterans Affairs (VA) Office of Research and Development at the Atlanta VA Medical Center.\n As outlined in the study protocol, the conflicts in Afghanistan and Iraq have resulted in a large number of veterans with both mTBI and PTSD, making these conditions important concerns of the Department of Veterans Affairs.1 Fifteen percent of Iraq and Afghanistan veterans suffer from mTBI resulting from their service,2 while 13% suffer from PTSD.3 The study, which plans to enroll 100 veterans, is designed to assess the clinical and physiological effects of nVNS in patients with mTBI and PTSD. The study’s primary outcome measures include assessments of the veterans’ clinical improvement, several objective measurements of brain activity, and changes in the levels of the inflammatory cytokine interleukin-6 (IL6) in response to stress. mTBI and PTSD disorders have a high degree of overlap, making diagnostic evaluation complex. It is estimated that up to 56% of mTBI patients have co-morbid PTSD,1, 4 and 18% of veterans of the conflicts in Iraq and Afghanistan present with co-morbid mTBI-PTSD,4, 5 making the co-morbid condition more common than either disorder alone. These veterans have higher PTSD symptom levels, more functional impairment,6 increased suicidal ideation,7 poorer health and cognitive function,8 and more post concussive symptoms4 than veterans with either condition alone. Dr. Douglas Bremner, Professor of Psychiatry and Behavioral Sciences and Radiology at the Emory University School of Medicine, staff physician at the Atlanta Veterans Clinic General Mental Health Unit at the Atlanta VA Medical Center and primary investigator of the study commented, “Veterans with these comorbid conditions represent a major portion of those presenting for treatment for conditions related to service in Iraq and Afghanistan and yet there is no single treatment effective for the full range of cogn...