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 Researc
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, Nock MK, 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™ (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck as an adjunctive therapy to treat migraine and cluster headache through the utilization of a mild electrical stimulation to the vagus nerve that passes through the skin. Designed as a portable, easy-to-use technology, gammaCore can be self-administered by patients, as needed, without the potential side effects associated with commonly prescribed drugs. When placed on a patient’s neck over the vagus nerve, gammaCore stimulates the nerve’s afferent fibers, which may lead to a reduction of pain in patients.
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.
- Safety and efficacy of gammaCore have not been evaluated in the following patients:
- Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
- Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy)
- Pediatric patients
- Pregnant women
- Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia
- Patients should not use gammaCore if they:
- Have an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
- Have a metallic device such as a stent, bone plate, or bone screw implanted at or near their neck
- Are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone)
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.
Please refer to the gammaCore Instructions for Use for all of the important warnings and precautions before using or prescribing this product.
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.
electroCore, Inc. is a commercial stage bioelectronic medicine company dedicated to improving patient outcomes through its platform non-invasive vagus nerve stimulation therapy initially focused on the treatment of multiple conditions in neurology. The company’s current indications are the preventative treatment of cluster headache and migraine and acute treatment of migraine and episodic cluster headache.
For more information, visit www.electrocore.com.
Forward-Looking Statement
This press release 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 the potential for nVNS to treat mild traumatic brain injury and Post-Traumatic Stress Disorder, and other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “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 raise the additional funding needed to continue to pursue electroCore’s business, sales and marketing, and product development plans, the inherent uncertainties associated with developing new products or technologies, the ability to successfully commercialize gammaCore™, competition in the industry in which electroCore operates and overall market conditions. Any forward-looking statements are made as of the date of this press release, and electroCore assumes no obligation to update the 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 consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents electroCore files with the SEC available at www.sec.gov.
Investors:
Hans Vitzthum
LifeSci Advisors
617-430-7578
hans@lifesciadvisors.com
or
Media Contact:
Jackie Dorsky
electroCore
973-290-0097
