We were lucky to get an interview with electroCore, a company which makes a vagus nerve stimulation device that is cleared for migraine. Their device, the gammaCore Sapphire is one of the devices that we are excited about as a non-pharmacological method for treating migraine attacks. – Grace from Innovation in Migraine
What is the gammaCore Sapphire?
gammaCore (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.
How does it work?
A clinical update reviewing non-invasive vagus nerve stimulation for the treatment of primary headache1 was recently published in Cephalalgia- the official journal of the International Headache Society. This paper provides insights into the diverse mechanistic pathways affected by nVNS, focusing on those involved in headache disorders.
These pathways include the:
- Effects on autonomic nervous system function
- Inhibition of cortical spreading depression (CSD)
- Neurotransmitter regulation
- Nociceptive modulation
Clinically, the authors recommend nVNS as “a first line treatment for both the acute and preventive treatment of cluster headache, an effective option for acute treatment of migraine, and a highly relevant, practical option for migraine prevention.”1
For your convenience, I have included a link to the publication below. Should you have any additional scientific questions related to the article, please email firstname.lastname@example.org.
Article Link here
Can you share some information on the efficacy of the gammaCore Sapphire?
gammaCore therapy results vary from person to person. A patient may experience rapid relief after giving an acute treatment with gammaCore at the first indication of migraine or episodic cluster headache pain. If one uses the device several times a day as a preventative therapy for migraine or cluster headache, patients may also notice a decrease in the severity, duration, and frequency of headaches. It is possible to reduce the use of one’s patient’s headache medications with gammaCore therapy. Most patients, when trained on the proper use of the device, will see a response within 3-5 acute attacks. Continued use of gammaCore demonstrated additional benefit over several weeks and even months in clinical trials.
Highlights for Migraines Observed in Clinical Studies include:
- Fast Relief: Some adults felt relief as quickly as 30 minutes
- Reliable Relief: Almost half of the patients had little to no migraine pain within 2 hours after first use
- Long-lasting Relief: The majority of patients who were pain-free at 2 hours remained pain-free for 48 hours
- gammaCore was proven to reduce the number of migraine attacks
- Quality of Life: decrease in migraine associated disability and improvement in quality of life across all QOL endpoints in the study
- Adverse events were mild and transient
Highlights for Cluster Headaches Observed in Clinical Studies Include:
- Fast Relief: gammaCore (nVNS) provided significant relief at 15 minutes for many adults
- Reliable Relief: gammaCore provided relief for more than 50% of attacks for many patients with episodic cluster headache
- Reduction in Duration: gammaCore may decrease the length and severity of attacks gammaCore was proven to reduce the number of cluster headache attacks per week when used with other medications
- Adverse events were mild and transient
How is the gammaCore Sapphire innovative?
Unlike traditional vagus nerve stimulation therapies, gammaCore stimulates the nerve non-invasively through the skin without the need for surgery. gammaCore avoids many drug-like side effects and inconveniences associated with injectable, inhaled, or pill-based medicines. While some patients find their current treatment regimen to be effective, it can raise concerns for others for reasons including unwanted side effects, overuse of medication, inconsistent relief, or a drug aversion. gammaCore can be used whenever and wherever convenient for the patient. Many headache treatments require an in-patient visit to the clinic to action them (Botox treatment), and often require medical monitoring during use such as the use of verapamil in Cluster Headache which requires routine ECG checks.
What is Electrocore’s vision for people living with migraine?
Our mission is simple—help patients across the globe who suffer from pain and chronic conditions. We are doing this by harnessing the power of nVNS, innovation, and technology to develop a safe and clinically backed treatment. Bringing new treatments to market will help improve patients’ treatment options and lives.
What other innovations or research in migraine are you really excited about at the moment?
It is extremely positive to see so many new migraine treatments being developed and evaluated at present. There are numerous new drugs, biological agents and medical technologies being made available to providers and patients. Additional therapeutic options mean patients’ have a much better chance of finding the right tool or combination of tools for them to help manage their condition.
If you could share one message about migraine to the wider community, what would it be?
The brain is an electrochemical organ that sometimes responds to medications. At other times we need to harness the power of electricity. Many patients don’t want to be taking drugs, and may be worried about both short and long term side effects of putting chemicals into their bodies. Other times drugs simply don’t work well enough for patients and they need alternative strategies. Healthcare providers and patients alike need many tools in their tool box to help relieve migraine pain.
We’d like to thank electroCore for being so kind in letting us interview them and we look forward to seeing new innovative products they produce over time to help those with chronic illnesses and pain. – Grace from Innovation in Migraine
Important Safety Information
gammaCoreTM (non-invasive vagus nerve stimulator) is intended to provide non-invasive vagus nerve stimulation (nVNS) on the side of the neck. gammaCore is indicated for:
- The preventive treatment of migraine headache in adolescent (age 12 and older) and adult patients.
- The acute treatment of pain associated with migraine headache in adolescent (age 12 and older) and adult patients.
- 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.
- The effectiveness of gammaCore has not been established in the acute treatment of chronic cluster headache
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 your neck ○
- Are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone)
Efficacy of gammaCore has 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 (younger than 12 years)
- Pregnant women
- Patients with clinical significant hypertension, hypotension, bradycardia, or tachycardia
NOTE: This list is not all inclusive. Please refer to the gammaCore Instructions for Use for all of the important warnings and precautions before using or prescribing this product.