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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 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. 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 cognitive and stress symptoms associated with mTBI-PTSD.9 For these reasons, our focus is on veterans with comorbid mTBI and PTSD as a highly relevant condition which deserves the attention of the VA.” “We are very pleased to be selected to participate in this important study,” said Peter Staats, MD, Chief Medical Officer of electroCore. “This study builds on recent published work by Dr. Bremner and colleagues that supports the clinical role for nVNS for the treatment of mTBI and PTSD, and we are optimistic that those findings will be further confirmed by the results from this study.” The study is supported by a VA Merit Award. For complete details please see clintrials.gov. (NCT04437498) References 1. Lew HL, Cifu DX, Crowder T and Hinds SR. National prevalence of traumatic brain injury, posttraumatic stress disorder, and pain diagnoses in OIF/OEF/OND Veterans from 2009 to 2011. J Rehabil Res Dev. 2013;50:xi-xiv. 2. Hoge CW, McGurk D, Thomas JL, Cox AL, Engel CC and Castro CA. Mild traumatic brain injury in U.S. Soldiers returning from Iraq. New England Journal of Medicine. 2008;358:453-63. 3. Hoge CW, Castro CA, Messer SC, McGurk D, Cotting DI and Koffman RL. Combat duty in Iraq and Afghanistan, mental health problems, and barriers to care. New England Journal of Medicine. 2004;351:13-22. 4. Bremner JD. PTSD and mild traumatic brain injury. In: J. D. Bremner, ed. Posttraumatic Stress Disorder: From Neurobiology to Treatment Hoboken, N.J.: Wiley-Blackwell; 2016: 321-344. 5. Bryant RA. Mental disorders and traumatic injury. Depress Anxiety. 2011;28:99-102. 6. Ragsdale KA, Neer SM, Beidel DC, Frueh BC and Stout JW. Posttraumatic stress disorder in OEF/OIF veterans with and without traumatic brain injury. J Anxiety Disord. 2013;27:420-6. 7. Wisco BE, Marx BP, Holowka DW, Vasterling JJ, Han SC, Chen MS, Gradus JL, NockMK, Rosen RC and Keane TM. Traumatic brain injury, PTSD, and current suicidal ideation among Iraq and Afghanistan U.S. veterans. J Trauma Stress. 2014;27:244-8. 8. Zatzick DF, Rivara FP, Jurkovich GJ, Hoge CW, Wang J, Fan MY, Russo J, Trusz SG, Nathens A and Mackenzie EJ. Multisite investigation of traumatic brain injuries, posttraumatic stress disorder, and self-reported health and cognitive impairments. Arch Gen Psychiatry. 2010 Dec;67(12):1291-300 9. Brenner LA, Ivins BJ, Schwab K, Warden D, Nelson LA, Jaffee MS and Terrio H. Traumatic brain injury, posttraumatics stress disorder, and postconcussive symptom reporting among troops returning from Iraq. Journal of Head Trauma Rehabilitation. 2010;25:307-312. About gammaCore™ gammaCore is FDA cleared in the United States for adjunctive use for the preventive treatment of cluster headache in adult patients, the acute treatment of pain associated with episodic cluster headache in adult patients, the acute treatment of pain associated with migraine headache in adult patients, and the prevention of migraine in adult patients. gammaCore is CE-marked in the European Union for the acute and/or prophylactic treatment of primary headache (Migraine, Cluster Headache, Trigeminal Autonomic Cephalalgias and Hemicrania Continua) and Medication Overuse Headache in adults. In 2019, NICE published an evidence-based Medical Technology Guidance document recommending the use of gammaCore for cluster headache within NHS England.
In the US, the FDA has not cleared gammaCore for the treatment of pneumonia and/or respiratory disorders such as acute respiratory stress disorder associated with COVID-19. The United States FDA has authorized use of the gammaCore Sapphire CV device for acute use at home or in a healthcare setting to treat adult patients with known or suspected COVID-19 who are experiencing exacerbation of asthma-related dyspnea and reduced airflow, and for whom approved drug therapies are not tolerated or provide insufficient symptom relief as assessed by their healthcare provider, by using non-invasive vagus nerve stimulation (VNS) on either side of the patient’s neck, available under an emergency access mechanism called an EUA. gammaCore Sapphire CV has neither been cleared nor approved for acute use at home or in a healthcare setting to treat adult patients with known or suspected COVID-19 who are experiencing exacerbation of asthma-related dyspnea and reduced airflow, and for whom approved drug therapies are not tolerated or provide insufficient symptom relief as assessed by their healthcare provider, by using non-invasive Vagus nerve Stimulation (nVNS) on either side of the patient’s neck during the Coronavirus Disease 2019 (COVID-19) pandemic. gammaCore Sapphire CV has been authorized for the above emergency use by FDA under an Emergency Use Authorization. gammaCore Sapphire CV has been authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of medical devices under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked. Further information is available at: Authorization Letter: https://www.fda.gov/media/139967/download Fact Sheet for Healthcare Providers: https://www.fda.gov/media/139968/download Fact Sheet for Patients: https://www.fda.gov/media/139969/download Instructions for gammaCore use https://www.fda.gov/media/139970/download About electroCore, Inc. For more information, visit www.electrocore.com. Forward-Looking Statement Investors: or Media Contact: |