Two prospective, peer reviewed trials demonstrate the symptomatic benefit of gammaCore in patients with PTSD
ROCKAWAY, N.J., Sept. 27, 2023 (GLOBE NEWSWIRE) -- electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine and wellness company, today announced the publication of two peer reviewed publications supporting the use of gammaCore (non-invasive vagal nerve stimulation; nVNS) in patients with posttraumatic stress disorder (PTSD). The first paper entitled “Effect of transcutaneous cervical vagus nerve stimulation on declarative and working memory in patients with Posttraumatic Stress Disorder (PTSD): A pilot study” was authored by Tilendra Choudhary and the second, “Transcutaneous vagal nerve stimulation modulates stress-induced plasma ghrelin levels: A double-blind, randomized, sham-controlled trial” was written by Kasra Moazzami. Both studies were conducted at Emory University and were published in the peer reviewed Journal of Affective Disorders.
The prevalence of PTSD in the United States is estimated at 10-12% in women and 5-6% in men, and the prevalence in veterans can be twice as high. PTSD is the third most common service-connected disorder in veterans and is associated with considerable morbidity and impairment in function. PTSD is associated with an increase in medical disorders and utilization of medical resources which places a significant emotional and economic burden on society. It is believed that many veterans do not seek or obtain appropriate treatment making it an important priority for the Veterans Administration (VA).
PTSD treatments, which include pharmacotherapy and psychotherapy, have many limitations for many veterans. Standard pharmaceutical treatments can have side effects and/or limited efficacy and half of veterans with PTSD drop out of psychotherapy treatments.
The study of 15 symptomatic subjects with a clinical diagnosis of PTSD suggested that transcutaneous vagus nerve stimulation (tcVNS) improves attention, and declarative and working memory, in patients with PTSD as measured by multiple endpoints. The study was conducted over the course of three months. The results show that the active group developed better attention and recall of paragraphs encoded with stimulation with a 91.4% improvement over the course of the study (p < 0.05) in paragraph recall. The study also showed a trend towards improvement in working memory tasks.1
The second study enrolled 55 subjects and the authors concluded that tcVNS could reduce the levels of ghrelin in response to various stressful stimuli. Ghrelin is a neuropeptide hypothesized to be involved in the stress response but also plays an important role in the regulation of appetite. Biomarkers that can be easily assessed can help identify likely responders to a specific therapy and are critical to improving the patient experience and decreasing health care costs. The results of this study showed that tcVNS, in conjunction with personalized traumatic scripts, resulted in lower ghrelin levels (265.2 ± 143.6 pg/ml vs 478.7 ± 349.2 pg/ml, P = 0.01). Additionally, after completing the public speaking and mental arithmetic tests, ghrelin levels were found to be lower in the group receiving tcVNS (293.3 ± 102.4 pg/ml vs 540.3 ± 203.9 pg/ml, P = 0.009).2 Ghrelin may be involved in behaviors like stress-induced over-eating, suggesting future avenues of research into the potential for nVNS in the treatment of obesity and possibly stress-induced eating disorders.
The senior co-author of both papers, Dr. Douglas Bremner, Professor of Psychiatry and Behavioral Sciences at Emory University and a Staff Physician at the Atlanta VA Medical Center, commented, “These two studies add to the growing body of evidence that tcVNS represents a promising new treatment for PTSD.” Dr. Bremner continued, “The identification of a possible biomarker that can be measured in plasma, with the demonstration of a marked improvement in memory after a stressful trigger, is an exciting advance for both clinicians and, most importantly, patients suffering from PTSD.”
Peter Staats, MD, Chief Medical Officer of electroCore, commented, “The impact of PTSD on millions of Americans including current warfighters and our Veterans is well understood. We desperately need new, safe, non-drug options and the data continues to suggest that gammaCore is a possible option. We thank Professors Bremner and Inan and their teams at Emory University, The Georgia Institute of Technology and the Atlanta VA for their tireless efforts to help their patients with PTSD.”
About electroCore, Inc.
electroCore, Inc. is a commercial stage bioelectronic medicine and wellness company dedicated to improving health through its non-invasive vagus nerve stimulation (“nVNS”) technology platform. Our focus is the commercialization of medical devices for the management and treatment of certain medical conditions and consumer product offerings utilizing nVNS to promote general wellbeing and human performance in the United States and select overseas markets.
For more information, visit www.electrocore.com.
This press release and other written and oral statements made by representatives of electroCore may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about electroCore's business prospects and clinical and product development plans including potential commercial applications of gammaCore and nVNS for improved attention and declarative and working memory in patients with PTSD as well as their effect on stress-induced levels of ghrelin; its pipeline or potential markets for its technologies; the timing, outcome and impact of regulatory, clinical and commercial developments; the issuance of U.S. and international patents, including patents related to non-invasive nerve stimulation with mobile devices, providing expanded IP coverage; the possibility of future business models, the potential of nVNS generally and gammaCore in particular and other statements that are not historical in nature, particularly those that utilize terminology such as "anticipates," "expects," "believes," "intends," other words of similar meaning, derivations of such words and the use of future dates. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the ability to obtain additional financing necessary to continue electroCore's business, sales and marketing and product development plans, the uncertainties inherent in the development of new products or technologies, the ability to successfully commercialize gammaCore™, competition in the industry in which electroCore operates and general market conditions. All forward-looking statements are made as of the date of this press release, and electroCore undertakes no obligation to update forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should refer to all information set forth in this document and should also refer to the disclosure of risk factors set forth in the reports and other documents electroCore files with the SEC, available at www.sec.gov.
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1 Choudhary T, Elliott M, Euliano NR, Gurel NZ, Rivas AG, Wittbrodt MT, Vaccarino V, Shah AJ, Inan OT, Bremner JD. Effect of transcutaneous cervical vagus nerve stimulation on declarative and working memory in patients with Posttraumatic Stress Disorder (PTSD): A pilot study. J Affect Disord. 2023 Oct 15;339:418-425. doi: 10.1016/j.jad.2023.07.025. Epub 2023 Jul 12. PMID: 37442455.
2 Moazzami K, Pearce BD, Gurel NZ, Wittbrodt MT, Levantsevych OM, Huang M, Shandhi MMH, Herring I, Murrah N, Driggers E, Alkhalaf ML, Soudan M, Shallenberger L, Hankus AN, Nye JA, Vaccarino V, Shah AJ, Inan OT, Bremner JD. Transcutaneous vagal nerve stimulation modulates stress-induced plasma ghrelin levels: A double-blind, randomized, sham-controlled trial. J Affect Disord. 2023 Sep 14;342:85-90. doi: 10.1016/j.jad.2023.09.015. Epub ahead of print. PMID: 37714385.