Study of Non-Invasive Vagus Nerve Stimulation (nVNS) Shows Improvement in PTSD Symptoms and Decreased Inflammatory Response to Stress
10 Agosto 2021 - 9:00AM
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.
About gammaCoreTMgammaCoreTM
(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.
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 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.
Investors:
Rich Cockrell
CG Capital
404-736-3838
ecor@cg.capital
or
Media Contact:
Jackie Dorsky
electroCore
908-313-6331
Jackie.dorsky@electrocore.com
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