ROCKAWAY, NJ, June 24, 2021 (GLOBE NEWSWIRE) — electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced the publication of a peer-reviewed paper on June 10, 2021, entitled “Effects of Transcutaneous Vagal Nerve Stimulation (tVNS/nVNS) on Cognitive Performance under Sleep Deprivation Stress,” in the journal
Communications Biology
, a
Nature
publication
.
The paper reports the positive results of a randomized, double-blind, sham-controlled trial conducted at Wright-Patterson Air Force Base using gammaCore Sapphire
TM
and sponsored by the United States Air Force Research Laboratories (USAFRL).
Fatigue is a serious and unavoidable problem for many professions such as medicine, transportation, and the military. Fatigue induced by sustained wakefulness can cause slower reaction times, reduced ability to multi-task, and increases in lapses of attention which can lead to costly, even deadly mistakes.
1
Studies on the behavioral implications of repeated sleep deprivation in humans have showed delayed reaction times, decreased accuracy and attention, and negative alterations in mood.
2
Although some pharmacological fatigue countermeasures do exist, they vary in their effectiveness, have a range of negative side effects, and may lose effectiveness with repeated use.
The study, which treated 40 United States Air Force personnel, investigated the use of nVNS as a fatigue countermeasure. This study was the first to assess cognitive performance during nVNS, and the first to do so under conditions of lengthy sleep deprivation.
Study participants were awake for 34 consecutive hours and tested at multiple time points assessing the effects of sleep deprivation on their ability to multi-task. The group treated with nVNS showed a statistically significant benefit in their throughput capacity when compared to the sham group, with the nVNS treated group’s throughput capacity decreasing by 5% from baseline vs. the sham group, which fell 15% (p<0.001). Furthermore, six stimulations of nVNS (12 minutes total) provided benefit to multi-tasking performance up to 15 hours post-stimulation, when performance should be at its worst. The study also found the nVNS group had a significantly smaller increase in a subjective fatigue rating when compared to sham participants (p<0.001).
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 the efficacy of nVNS as possible aid to cognitive performance and as a tool to counter fatigue. Improvements in our aviators’ ability to perform tasks during the study while feeling less fatigue suggest a range of possible roles for nVNS in combating these issues in both military and civilian settings.”
“We congratulate and thank Dr. McIntire, Dr. McKinley and their team at the 711
th
Human Performance Wing,” commented Eric Liebler, Senior Vice President of Neurology at electroCore. “Current options for helping maintain performance and combating fatigue are very limited and often come with unacceptable side effects and risks due to excessive use. We look forward to the results of the ongoing research at the USAFRL.”
The full publication is available at: https://www.nature.com/articles/s42003-021-02145-7
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 for the preventative treatment of cluster headache and migraine and acute treatment of migraine and episodic cluster headache.
For more information, visit www.electrocore.com.
About gammaCore
TM
gammaCore
TM
(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, 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 pacemaker, hearing aid implant, or 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 of age)
- Pregnant women
- Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia
Please refer to the gammaCore Instructions for Use for all the important warnings and precautions before using or prescribing this product.
Forward-Looking Statements
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 fatigue or enhance cognitive performance caused by sleep deprivation 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.
1
Perry, I.C. (Ed.) (1974). Helicopter aircrew fatigue. AGARD (Advisory Rep. No. 69). Neuilly sur Seine, France: Advisory Group for Aerospace Research and Development.
2
Krueger G.P. (1989). Sustained work, fatigue, sleep loss, and performance: a review of the issues.
Work Stress
, 3(2):129e41.
Investors: Rich Cockrell CG Capital 404-736-3838 [email protected] or Media Contact: Summer Diaz electroCore 816-401-6333 [email protected]
