Study of Non-Invasive Vagus Nerve Stimulation (nVNS) Shows Improvement in PTSD Symptoms and Decreased Inflammatory Response to Stress
Peer-reviewed manuscript reports results of study conducted at Georgia Tech and Emory, funded in part by DARPA
ROCKAWAY, NJ, August 10, 2021 (GLOBE NEWSWIRE) — electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced the publication of a peer-reviewed manuscript, “Transcutaneous Cervical Vagal Nerve Stimulation (tcVNS/nVNS) in Patients with Posttraumatic Stress Disorder (PTSD): A Pilot Study of Effects on PTSD Symptoms and Interleukin-6 Response to Stress” in the Journal of Affective Disorders Reports. The manuscript reports the results of a randomized, double-blind, sham-controlled study conducted at Georgia Institute of Technology and Emory University that resulted from work funded in part by the Defense Advanced Research Projects Agency (DARPA) Biological Technologies Office (BTO) Targeted Neuroplasticity Training (TNT) program through the Naval Information Warfare Center.
PTSD is a psychiatric disorder that may occur in people who have experienced or witnessed a traumatic event such as a natural disaster, serious accident, terrorist act, war, combat, or who have been threatened with death, sexual violence or serious injury. Eight million American adults experience PTSD annually, and with limited FDA approved therapies, there is a large unmet medical need. The disorder is more prominent in women, with about 10% of women and 4% of men developing PTSD at some point in their lives.
The study enrolled twenty patients suffering from PTSD. Study participants were exposed to personalized traumatic scripts followed by an immediate stimulation by an active or sham non-invasive vagus nerve stimulator (nVNS). The results show that three-months of treatment with nVNS lead to a 31% reduction (p<0.013) in PTSD symptoms compared to sham on the PTSD Checklist (PCL), as well as a significant decrease in hyperarousal symptoms (p=0.008) and a decrease in overall and somatic (gastric) anxiety. At the conclusion of the study, patients who continued to use nVNS for a further 3 month open-label period showed a significant improvement in their overall symptoms reported by the Clinical Global Index (p=0.003). Furthermore, nVNS effectively blocked the increase in the levels of the inflammatory cytokine IL-6 that is overexpressed in patients with PTSD who are exposed to a traumatic script (p<0.05).
Dr. Douglas Bremner, Professor of Psychiatry and Radiology at Emory University School of Medicine and the primary investigator for the study commented, “PTSD is a devastating condition that can strike at almost any time after physical or mental trauma. Current treatments do not address the breadth of what a person with PTSD experiences. Dr. Omer Inan, the Linda J. and Mark C. Smith Chair in Bioscience and Bioengineering, Associate Professor of Electrical and Computer Engineering at Georgia Institute of Technology, and co-investigator on the study added, “the results from this study, while still preliminary, suggest a role for nVNS as a practical and safe novel treatment for PTSD.”
“We congratulate and thank Dr. Bremner, Dr. Inan, and their clinical and research teams at Georgia Tech, Emory University and the University of Utah, as well as the patients and families that participated in this study,” commented Eric Liebler, Senior Vice President of Neurology at electroCore. “PTSD strikes both our veterans who serve at home and across the globe, as well friends and family members who can suffer from the repercussions of a trauma at any time. We are pleased to be able to support the team’s on-going efforts to further define the possible use of nVNS in people with PTSD.”
The full publication is available at: https://www.sciencedirect.com/science/article/pii/S2666915321001165?via%3Dihub
About electroCore, Inc.
electroCore, Inc. is a commercial stage bioelectronic medicine company dedicated to improving patient outcomes through its non-invasive vagus nerve stimulation therapy platform, initially focused on the treatment of multiple conditions in neurology. The company’s current indications are the preventive treatment of cluster headache and migraine and the acute treatment of migraine and episodic cluster headache.
For more information, visit www.electrocore.com.
gammaCoreTM (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 (nVNS) 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, and the acute and preventive treatment of migraine in adolescent (ages 12 and older) and 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.
gammaCore is contraindicated for patients 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 the neck
- Are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone)
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 (less than 12 years)
- Pregnant women
- Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia
Please refer to the gammaCore Instructions for Use for all of the important warnings and precautions before using or prescribing this product.
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; its pipeline or potential markets for its technologies; the timing, outcome and impact of regulatory, clinical and commercial developments; the availability and impact of payer coverage, the potential of nVNS generally and gammaCore in particular to treat PTSD symptoms and related disorders 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 and product development plans, the inherent uncertainties associated with developing new products or technologies, the ability to commercialize gammaCore™, the potential impact and effects of COVID-19 on the business of electroCore, electroCore’s results of operations and financial performance, and any measures electroCore has and may take in response to COVID-19 and any expectations electroCore may have with respect thereto, 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.
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