Benzinga | Jun 24, 2021 08:21AM EDT

electroCore Highlights Publication Of Study On Effect Of Non-Invasive Vagus Nerve Stimulation In Cognitive Performance Caused By Sleep Deprivation

lectroCore, 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 SapphireTM 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 711th 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