Vagus Nerve Society

Vagus Nerve in the Media

Vagus Nerve in the Media

Russell Wilson Recognizes Dr. Antonucci is His Concussion Recovery

Articles:

Vagus Nerve Stimulation May Ease Fatigue in Sjögren’s Patients
by Marisa Wexler, MS – December 6, 2022

Vagus nerve stimulation (VNS), a procedure using a hand-held device to deliver electrical pulses to a nerve in the neck, eased fatigue for people with Sjögren’s syndrome in a small clinical trial.
“Our data support further investigation into the role of [VNS] as a treatment for fatigue in patients with [Sjögren’s],” the researchers wrote.

Trial findings were reported in the study, “The Effects of Noninvasive Vagus Nerve Stimulation on Fatigue in Participants With Primary Sjögren’s Syndrome,” published in the journal Neuromodulation: Technology at the Neural Interface.

Treating fatigue in Sjögren’s syndrome with hand-held device
Fatigue — persistent feelings of tiredness and lack of energy, even when well-rested — is a common and burdensome Sjögren’s symptom. Many factors likely contribute to patients’ fatigue, including dysfunction of the autonomic nervous system, the branch of the nervous system responsible for regulating unconscious bodily processes like digestion and breathing.

The vagus nerve, a large nerve that runs down the neck, serves as a highway for many signals sent in the autonomic nervous system. VNS is a treatment approach, using a device to deliver electrical signals to the vagus nerve, first approved in the 1990s for use in epilepsy. It has since been explored in a range of conditions.

Here, a team led by researchers in the U.K. conducted a small trial to investigate whether VNS might help ease fatigue in people with primary Sjögren’s.

The double-blind study enrolled 40 patients with notable fatigue and divided them into two groups. In one, patients received VNS, given at the home twice daily in two-minute sessions, for about two months (54 days). People in the other group received a sham procedure mimicking the tingly sensation caused by VNS, but one that did not actually stimulate the vagus nerve.

VNS was delivered using a noninvasive device called gammaCore, which is authorized in the U.S. to administer VNS as a treatment for migraines and cluster headaches. Two of the study’s more than 20 authors are employees and stockholders at electroCore, the company that markets this device.

Fatigue was measured using three standardized numeric scales: the physical and mental versions of the Profile of Fatigue (PRO-F-Physical and PRO-F-Mental), as well as the Visual Analogue Scale of abnormal fatigue (fVAS).

Across all three of these measures, scores significantly decreased over the course of the study for patients given VNS. Specifically, median PRO-F-Physical scores dropped by 28%, PRO-F-Mental by 25%, and fVAS by 20%. By comparison, fatigue scores did not change significantly in patients given sham stimulation.

“The key analyses in this study showed a significant reduction in three patient-reported measures of fatigue with the active device but not the sham device,” the researchers wrote.

Other psychological and cognitive assessments generally did not differ between the groups, though small positive effects were seen in a neurocognitive test called digit span, which requires a person to memorize a sequence of numbers.

In additional analyses, researchers noted that a measure of vagus nerve activity, called alpha reactivity, correlated with improvements in fatigue scores among patients given VNS, but not in those treated with the sham device.

“The relationship between fatigue and alpha reactivity observed deserves further investigation in the future,” the researchers wrote.

Scientists stressed that this study is limited by its short duration and small size, with 10 patients — seven in the active treatment group — not being included in the analyses largely because they either did not complete the study or were using the device incorrectly.

“The resultant data set available for analysis has reduced our statistical power, so we took care to avoid overinterpretation of results. Future studies would benefit from a much larger sample size,” the team wrote.

electroCore, Inc. Announces Study of gammaCore Sapphire™ for the Treatment of Post-COVID Syndrome
ROCKAWAY, N.J., July 07, 2022 (GLOBE NEWSWIRE)

electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced Mayo Clinic is initiating an investigator-initiated study to assess the efficacy of gammaCore Sapphire non-invasive vagus nerve stimulation (nVNS) in patients with post-COVID syndrome. Post-COVID syndrome, also known as Long COVID, is a collection of symptoms that persist greater than 28 days after the initial onset of symptoms of SARS-CoV-2 (COVID) infection1,2. These symptoms, such as headache, brain fog, fatigue and gastric distress can bear a striking resemblance to the “central sensitization syndromes,” a group that includes fibromyalgia, chronic fatigue syndrome, and postural orthostatic tachycardia syndrome (POTS). Post-COVID syndrome is likely to occur in upwards of 10% of the population who has been infected with COVID, likely affecting hundreds of millions across the world.

The study entitled “Outcomes of treatment with non-invasive vagal nerve stimulation (nVNS) in post-COVID syndrome: A Pilot Study,” is a randomized, single-center, controlled trial enrolling up to 20 subjects recruited from the Post-COVID Care Clinic at Mayo Clinic in Rochester, Minnesota. Endpoints of the study include a number of clinical questionnaires including the Post-COVID Functional Status Score, as well as an analysis of blood samples for certain chemokines, and positron emission tomography-computed tomography (PET-CT) of the brain to evaluate brain metabolism.

“Long-COVID represents a significant ongoing medical challenge that can extend long after the acute phase of COVID,” said Dr. Peter Staats, Chief Medical Officer at electroCore, Inc. “We believe the decision to use gammaCore Sapphire is consistent with its demonstrated mechanisms of action and its use in acute-COVID under an Emergency Use Authorization granted by the Food and Drug Administration.”

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, the acute treatment of migraine and episodic cluster headache, the acute and preventive treatment of migraines in adolescents, and paroxysmal hemicrania and hemicrania continua in adults.
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 (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, and paroxysmal hemicrania and hemicrania continua in 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:

  • Adolescent patients with congenital cardiac issues
  • 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

For more information, please visit gammaCore.com

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 with and resulting from work in conjunction with the Mayo clinic; business prospects around treatment of Post-COVID Syndrome or other new markets 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 Bierle, D.M., et al., Central Sensitization Phenotypes in Post Acute Sequelae of SARS-CoV-2 Infection (PASC): Defining the Post COVID Syndrome. J Prim Care Community Health, 2021. 12: p. 21501327211030826.

2 Soriano, J.B., et al., A clinical case definition of post-COVID-19 condition by a Delphi consensus. The Lancet Infectious Diseases, 2022. 22(4): p. e102-e107.

An Explanation of the Vagus Nerve and Why We Would Stimulate It
By Women Fitness Magazine -June 29, 2022

An Explanation of the Vagus Nerve and Why We Would Stimulate It : The vagus nerve is one of the most important nerves in the human body. It runs from the brain down to the abdomen, and it plays a key role in controlling many different bodily functions.

Recently, there has been a lot of interest in the vagus nerve stimulation device being used for a variety of health benefits.

Here, we will explore some of those benefits.

What is the Main Function of the Vagus Nerve?
One of the most important functions of the vagus nerve is controlling the parasympathetic nervous system. This part of the nervous system helps to regulate things like heart rate, digestion, and blood pressure. When the vagus nerve is stimulated, it can help to slow down an overactive heart rate, and it can also help to improve digestion.

The vagus nerve is responsible for controlling the heart rate. When the vagus nerve is stimulated, it slows the heart rate down, which can be beneficial in cases of cardiac arrest or abnormal heart rhythms. Stimulating the vagus nerve can also help to reduce stress and anxiety, which can improve overall cardiovascular health.

The vagus nerve is a cranial nerve that originates from the brainstem and exits the skull through the jugular foramen. It has two main functions: to stimulate the heart and to control the digestive system. The vagus nerve plays a significant role in digestion, controlling all the muscles of the digestive tract from the stomach to the rectum. It also regulates the production of enzymes and stomach acids.

There are many health benefits associated with vagus nerve stimulation. Vagus nerve stimulation has been shown to help treat conditions like Alzheimer’s disease, depression, anxiety, and chronic pain. It can help improve heart health, gastrointestinal health, and immunity.

Vagus nerve stimulation is a safe and effective way to improve overall health and well-being. If you are interested in vagus nerve stimulation, talk to your doctor to see if it is right for you.

Other Functions of the Vagus Nerve
In addition to controlling the parasympathetic nervous system, the vagus nerve also plays a role in communication between the brain and the gut. This is why vagus nerve stimulation has been shown to help treat conditions like irritable bowel syndrome and inflammatory bowel disease. The vagus nerve can also help to reduce inflammation throughout the body, and this is thought to be one of the main ways that vagus nerve stimulation can improve overall health.

Vagus Nerve Stimulation for Health Benefits
There are a few different ways to stimulate the vagus nerve, but one of the most common methods is through electrical stimulation. This can be done using a device that is placed under the skin, and the electrical impulses will then travel through the vagus nerve. Vagus nerve stimulation has been shown to help treat a wide variety of conditions, including:

  • Alzheimer’s disease
  • Anxiety
  • Depression
  • Epilepsy
  • Heart failure
  • Migraines
  • Multiple sclerosis
  • Parkinson’s disease

There is some evidence that vagus nerve stimulation could be beneficial for treating Alzheimer’s disease. One study showed that vagus nerve stimulation improved cognitive function and reduced inflammation in mice with Alzheimer’s. More research is needed to determine if vagus nerve stimulation is an effective treatment for Alzheimer’s in humans, but the early results are promising.

It is good to know that there is another solution to tackling anxiety and depression. These are widespread problems that many people will face daily. They are debilitating and stop people being able to perform to their best and enjoy life.

Migraines are more than just a headache because they have other symptoms attached to them and can temporarily put people out of action. So, to be able to reduce their severity is a comfort for many.

The above is quite a range for one device to help with. The list above that is connected to nerve stimulation treatment is encouraging for all those currently suffering.

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