electroCore, Inc. (Nasdaq: ECOR), a commercial-stage
bioelectronic medicine and wellness company, today announced the
publication of a peer reviewed manuscript, Effect of
Transcutaneous Cervical Vagus Nerve Stimulation on Declarative and
Working Memory in Patients with Posttraumatic Stress Disorder
(PTSD): A Pilot Study, in the Journal of Affective
Disorders. The study was conducted with the support
of Emory University, The Georgia Institute of Technology and
the Atlanta Veteran’s Affairs Medical Center and was sponsored by a
Department of Defense Small Business Technology Transfer grant (DoD
STTR).
PTSD is an extreme mental health condition
associated with changes in multiple neurophysiological systems such
as inflammation and the autonomic nervous system and contributing
to deficits in memory. Many patients have limited or no response to
currently available treatments for PTSD symptoms and associated
cognitive dysfunction. According to the American Psychiatric
Association, exposure to traumas including accidents or other
life-threatening incidents can initiate the development of PTSD, a
complex syndrome involving core symptoms of hyperarousal, avoidance
and re-experiencing symptoms, and associated decreases in
concentration and memory1,2 (Hou et al., 2007; Williams and First,
2013).
Vagus Nerve Stimulation (VNS) has been shown in
preliminary studies to enhance function when paired with cognitive
and motor tasks. The randomized double-blinded study enrolled
fifteen patients (nVNSActive = 8; nVNSSham =7), was conducted over
the course of three months of twice daily home-based nVNS
self-administered treatments and assessed the effectiveness of nVNS
on declarative and working memory in patients with PTSD. The study
concluded the active group developed better attention and recall of
paragraphs encoded with stimulation as well as for working memory
tasks as compared to sham. The improvement in working memory for
patients with PTSD who used nVNS compared to sham was statistically
significant at 4 weeks (57.1%; p=0.01) and continued to improve
through 8 weeks (91.4%; p=0.03).
Dr. Douglas Bremner, Professor of Psychiatry
and Radiology at Emory University School of Medicine and
the primary investigator for the study, commented, “nVNS continues
to demonstrate its potential as a safe, convenient and potentially
effective treatment for people suffering from PTSD. The
improvements in memory seen in this study, complement our previous
research which has shown the beneficial effects of nVNS on some of
the basic mechanisms that lead to, and can exacerbate, PTSD3,4.This
longitudinal study shows benefit for cognitive symptoms associated
with PTSD and suggests that nVNS may improve work and social
functioning for patients with PTSD.”
“We congratulate and thank Dr.
Bremner, Dr. Inan, Dr. Choudhary and the clinical and research
teams at Emory University, Georgia Tech University and the
Atlanta VA for their support of this study,” commented Dan
Goldberger, Chief Executive Officer at electroCore. “We look
forward to the results of several larger on-going government
sponsored studies of nVNS as a treatment for PTSD and other future
indications.”
The full publication is available
at: https://www.sciencedirect.com/science/article/abs/pii/S0165032723008625
The content of the paper is solely the
responsibility of the authors and does not necessarily represent
the official views of study sponsors.
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.
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 Company’s business
prospects in cognitive symptoms associated with PTSD 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.
Contact:ECOR Investor
Relations(973) 302-9253investors@electrocore.com
____________________1 Hou, C., Liu, J., Wang, K.,
Li, L., Liang, M., He, Z., Liu, Y., Zhang, Y., Li, W., Jiang, T.,
2007. Brain responses to symptom provocation and trauma-related
short-term memory recall in coal mining accident survivors with
acute severe PTSD. Brain Res. 1144, 165–174.
https://doi.org/10.1016/j.brainres.2007.01.0892 Williams, J.B.W.,
First, M., 2013. Diagnostic and Statistical Manual of Mental
Disorders [WWW Document]. Encycl. Soc. Work.
https://doi.org/10.1093/acrefore/9780199975839.013.1043 Bremner,
J.D., Wittbrodt, M.T., Gurel, N.Z., Shandhi, M.H., Gazi, A.H.,
Jiao, Y., Levantsevych, O.M., Huang, M., Beckwith, J., Herring, I.,
Murrah, N., Driggers, E.G., Ko, Y.-A., Alkhalaf, M.L., Soudan, M.,
Shallenberger, L., Hankus, A.N., Nye, J.A., Park, J., Woodbury, A.,
Mehta, P.K., Rapaport, M.H., Vaccarino, V., Shah, A.J., Pearce,
B.D., Inan, O.T., 2021b. Transcutaneous Cervical Vagal Nerve
Stimulation in Patients with Posttraumatic Stress Disorder (PTSD):
A Pilot Study of Effects on PTSD Symptoms and Interleukin-6
Response to Stress. J. Affect. Disord. Rep. 6, 100190.
https://doi.org/10.1016/j.jadr.2021.1001904 Wittbrodt, M.T., Gurel,
N.Z., Nye, J.A., Shandhi, M.M.H., Gazi, A.H., Shah, A.J., Pearce,
B.D., Murrah, N., Ko, Y. A., Shallenberger, L.H., Vaccarino, V.,
Inan, O.T., Bremner, J.D., 2021. Noninvasive Cervical Vagal Nerve
Stimulation Alters Brain Activity During Traumatic Stress in
Individuals With Posttraumatic Stress Disorder. Psychosom. Med. 83,
969. https://doi.org/10.1097/PSY.0000000000000987
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