Type
Neurostimulation device
Developer
electroCore
Application
Acute and chronic migraine
Technology
Drug-free wearable
Development Status
Approved in the US by FDA
Please click here to read the main article for “ Tech-Enabled Migraine Relief: Wearables to the Rescue” based on extensive medical device research.
Migraine is a common health condition, affecting around 1 in every 5 women and around 1 in every 15 men. A migraine is usually described as a moderate or severe headache pain, typically felt on 1 side of the head. They usually begin in early adulthood. Many people also have symptoms such as feeling sick, being sick, and increased sensitivity to light or sound.
gammaCore is an FDA-cleared non-invasive device manufactured by electroCore Corporation, used to treat and prevent multiple types of headache pain via the vagus nerve. It’s small, handheld, and portable for quick and easy treatments whenever and wherever needed.
The gammaCore is a handheld device placed on the neck over the vagus nerve to treat migraines and cluster headaches, which are felt on one side of the head, often around the eye area.
Who gammaCore is not for
- Patients with an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
- 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
- Pregnant women
- Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia
Patients should not use gammaCore if they:
- Have a metallic device such as a stent, bone plate, or bone screw implanted at or near their neck
- Are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone)
How gammaCore Works?
Unlike an implanted vagus nerve stimulator or other migraine and cluster headache treatments, the gammaCoreTM non-invasive vagus nerve stimulator, otherwise known as nVNS, activates the vagus nerve with gentle electrical stimulation through the skin via the neck. Helping to prevent and relieve headache pain without pills, injections and drug-like side effects.
Migraine is a common health condition, affecting around 1 in every 5 women and around 1 in every 15 men. A migraine is usually described as a moderate or severe headache pain, typically felt on 1 side of the head. They usually begin in early adulthood. Many people also have symptoms such as feeling sick, being sick, and increased sensitivity to light or sound.
gammaCore is an FDA-cleared non-invasive device to treat and prevent multiple types of headache pain via the vagus nerve. It’s small, handheld, and portable for quick and easy treatments whenever and wherever needed.
The gammaCore is a handheld device placed on the neck over the vagus nerve to treat migraines and cluster headaches, which are felt on one side of the head, often around the eye area.
How to use gammaCore to prevent migraine headache
Daily
Give yourself 2 treatments (morning and night) consisting of 2 consecutive two-minute stimulations.
- The first daily treatment should be applied within 1 hour of waking. The second daily treatment should be applied at night.
- Apply conductive gel before each stimulation. After 2 minutes, gammaCore will beep twice and automatically discontinue stimulation.
- Stimulations during treatment should be applied on the same side of the neck. Additional treatments may be applied to either side of the neck.
- This is a suggested treatment. Please speak with your healthcare provider to determine the right plan for you.
At the earliest sign of pain
Give yourself a treatment consisting of 2 two-minute gammaCore (nVNS) stimulations.
Apply the conductive gel before each stimulation. After 2 minutes, gammaCore will beep twice and automatically turn off.
Stimulations can be administered on the same side of the neck, or you can switch sides if preferred.
Repeat treatment if pain persists.
This is a suggested treatment. Please speak with your healthcare provider to determine the right plan for you.
Frequently Asked Questions
How long does gammaCore last?
The gammaCore medical device comes with 3 months (93 days) of consecutive therapy preloaded. The device offers up to 24 stimulations each day, allowing you to treat several assaults if necessary. Treatment length may vary if you acquire your device from the VA.
What are the benefits of gammaCore?
The gammaCore(non-invasive vagus nerve stimulator) is approved for use in adult patients for the prevention of migraine and cluster headaches, as well as the acute treatment of migraine and episodic cluster headache pain.
How many times a day can you take gammaCore?
You can use gammaCore for up to four attacks (or eight different treatments) every day (for a total of 24 stimulations). The length of each stimulation (2 minutes) allows for proper positioning of the gammaCore and establishing the optimal intensity level.
When was gammaCore FDA approved?
gammaCore obtained FDA approval in April 2017 for the acute treatment of pain associated with episodic cluster headaches in adult patients.
Clinical Evidence for gammaCore
FDA approval of gammaCore to prevent cluster headaches was based on safety and efficacy data from the PREVA study, as well as data from a real-world study examining the daily use of gammaCore.
Key findings from the randomized, open-label PREVA study include:
Patients receiving gammaCore plus standard of care had 5.9 fewer cluster headache attacks per week, on average, compared with 2.1 fewer attacks (p = 0.02) in patients treated solely with standard of care. This translates to 3.9 fewer cluster attacks a week on average in those using gammaCore compared with those using medication or oxygen therapy alone.
Patients using gammaCore (in the randomized phase) reduced their use of abortive medication by 57% (p < 0.001). Patients who received standard of care alone did not experience a substantial reduction in abortive meds (p = 0.59).
40% of patients in the gammaCore group experienced a 50% or greater reduction in weekly cluster attacks, compared with 8.3% of patients who received standard of care alone (p < .001).
Treatment with gammaCore was safe and can be used in combination with drug treatments.
Most side effects were mild and transient. The most common adverse events reported in 5% of patients or more in the gammaCore group were: headache (8%), dizziness (6%) and neck pain (6%). None of the serious adverse events were considered device-related.
Clinical Evidence for Migraine
The FDA cleared gammaCore for acute migraine treatment based primarily on the results of a randomized, double-blind, sham-controlled trial called PRESTO (PRospectivE Study of nVNS for the Acute Treatment Of Migraine). The trial involved 243 patients with episodic migraine; 120 participants received the device while 123 patients received a sham treatment as a control.
Results from PRESTO found that acute treatment with gammaCore was superior to sham for pain freedom at 30, 60, and 120 minutes after use. In the PRESTO study, as with previous studies, gammaCore was well tolerated with a low incidence of adverse effects.
The full results:
- 12.7% of patients who used gammaCore were pain-free after 30 minutes (compared with 4.2% control)
- 21% were pain-free after 60 minutes (compared with 10% in the control)
- 30% were pain-free after 120 minutes (compared with 19.7% control)*
- 41% had mild or no pain after 120 minutes (compared with 27.6% control) *[Not statistically significant. The test was repeated to determine why the findings were not consistent at 120 minutes with the 30- and 60-minute findings. This second test confirmed that gammaCore was superior to the sham treatment after 120 minutes of use.]
Although gammaCore beat the sham treatment in the trial, only 41% of the 120 patients who received the device got complete relief or mostly complete relief after two hours.
The safety and utility of gammaCore for migraine were confirmed in a 2022 study, finding that participants who tried gammaCore experienced an average of 3.12 fewer migraine days a month, compared to 2.29 fewer migraine days experienced by the group who received sham treatment.
Conclusion
Like with most treatments, gammaCore won’t work for every person or with every attack. This new treatment does provide an exciting option and new hope for those unsatisfied with their current acute treatment. The low risk of side effects makes this device attractive for many looking for a more natural approach.
References
- https://www.migraineagain.com/gammacore-prevent-cluster-headaches/
- https://www.gammacore.com/about/testimonials/
- https://www.gammacore.com/about/how-gammacore-works/
- https://www.gammacore.com/about/faq/
