Clinical trial (n=36) shows the ability of gammaCore (nVNS) to significantly improve the recall of a foreign language compared to sham while simultaneously showing improved focus and decreased fatigue in study participants
ROCKAWAY, N.J., April 24, 2023 (GLOBE NEWSWIRE) -- electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine and wellness company, today announced that the Air Force Research Laboratories (AFRL) reported data from its study on the ability of gammaCore non-invasive vagus nerve stimulation (nVNS) to improve second language learning. The study was conducted at the Defense Language Institute (DLI) in Monterey, CA, the US Department of Defense’s premier language school. The study was supported by Defense Advanced Research Projects Agency (DARPA)/AFRL within the DARPA Targeted Neuroplasticity Training (TNT) program.
The study recruited 36 student participants from DLI’s Arabic school house (nVNS = 18 & Sham = 18). Each subject was assessed on day 1 to establish a baseline. On days 2-4, two 2-minute gammaCore (nVNS) stimulation treatments were self-administered by the subject, each before and after training. Assessments were taken each treatment day, and on day 5 where there was no treatment, assessments were conducted to assess possible carryover effects. The study showed a significant positive effect of gammaCore (nVNS) over sham (p=0.025) on language recall, thereby suggesting gammaCore’s (nVNS) ability to significantly improve the recall of a foreign language compared to sham. The improvement achieved through gammaCore (nVNS) treatment on days 2-4 was maintained on day 5 demonstrating that the recall advantage that emerged during training was sustained after the completion of treatment.
All participants completed the AFRL Mood Questionnaire on each day (1-5) of the study. From the a priori-selected three scales of the AFRL Mood Questionnaire, participants receiving gammaCore (nVNS) showed significant increases in energy (p=0.036) and focus (p=0.001) over the course of each training session compared to sham participants, and their calm score also trended towards an improvement from gammaCore (nVNS).
Dr. Richard McKinley, of the Air Force’s 711th Human Performance Wing, Human Effectiveness Directorate and an investigator of the study, commented, “We are pleased to have successfully completed the first randomized, double-blind sham-controlled trial demonstrating that gammaCore (nVNS) accelerated the learning of Arabic vocabulary in students at the Defense Language Institute. Equally impressive were the improvements in the subject’s energy and mood despite the rigors of the training program. This study compliments our findings that suggest gammaCore (nVNS) could be a valuable tool to enhance warfighter training and resilience in a range of areas.”
“We congratulate and thank the teams at DLI and AFRL for the dedicated work on this study as well as DARPA for their sponsoring the study,” commented Dr. Peter Staats, Chief Medical Officer of electroCore. “Cognitive performance and skill acquisition are central to the mission of many institutions in a wide variety of sectors including educational, commercial, and military. This study suggests gammaCore (nVNS) could accelerate these efforts.”
About The Air Force Research Laboratory (AFRL)
The Air Force Research Laboratory is the primary scientific research and development center for the Department of the Air Force. AFRL plays an integral role in leading the discovery, development, and integration of affordable warfighting technologies for our air, space, and cyberspace force. With a workforce of more than 11,500 across nine technology areas and 40 other operations across the globe, AFRL provides a diverse portfolio of science and technology ranging from fundamental to advanced research and technology development. For more information, visit: www.afresearchlab.com.
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.
About gammaCore™
gammaCore™ (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck 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 is 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 intended to provide non-invasive vagus nerve stimulation (nVNS) on the side of the neck for preventive treatment of migraine and the acute treatment of pain associated with migraine in patients 12 and older. gammaCore is also indicated for adjunctive use for preventive treatment of cluster headache, acute treatment of episodic cluster headache, and treatment of hemicrania continua and paroxysmal hemicrania in adult patients.
gammaCore should not be used by people with an active implantable medical device. Please refer to gammaCore.com or the Instructions for Use for complete safety information, including indications, contraindications, warnings, cautions, and instructions.
For more information, please visit gammaCore.com
Forward-Looking Statements
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 regarding the results from investigator-initiated trials, anticipated results and timing of clinical trials being conducted with gammaCore (nVNS), electroCore's business prospects, its sales and marketing and product development plans, future cash flow projections, anticipated costs, its product portfolio or potential markets for its technologies, the availability and impact of payor coverage, the potential of nVNS generally and gammaCore in particular to accelerate second language learning, improve focus and decrease fatigue, and other statements that are not historical in nature, particularly those using 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. The results of earlier preclinical studies and clinical trials may not be predictive of results of future preclinical studies, clinical trials, or commercial success. 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.
Contact:
Rich Cockrell
CG Capital
404-736-3838
ecor@cg.capital
