Researchers continue to discover new treatment options for people with migraine. Some help treat the pain of a migraine headache and others help reduce the frequency of attacks. One treatment option currently being explored is vagus nerve stimulation (VNS).
VNS isn’t considered a widely accessible therapy, but it has been FDA-cleared for the treatment and prevention of migraine and cluster headache.
If you’re curious about VNS for migraine, here’s the important information you need to know. You’ll learn about noninvasive VNS devices, how they work, and how much they cost.
As the name suggests, VNS is a treatment that stimulates the vagus nerve. The vagus nerve is one of 12 pairs of cranial nerves that originate in your brain. These nerves help your brain communicate with your body in a variety of different ways.
The vagus nerves — you have one on each side of your body — run from your brainstem down through your neck, chest, and abdomen.
Classic VNS is FDA approved for epilepsy and treatment-resistant depression. This classic VNS therapy involves an implantable, pacemaker-like device that must be placed by a neurosurgeon.
VNS for epilepsy and depression
The VNS device is implanted underneath your skin, and a wire is inserted to connect the device to the vagus nerve. The device sends mild electrical pulses through the vagus nerve, up into your brain. While this may sound intimidating, people with VNS devices don’t typically feel the electrical pulses.
Once the device is implanted, people are able to activate it by swiping a magnet in front of their chest.
New developments in VNS technology have led to more convenient, noninvasive therapies. These noninvasive therapies are what are currently being used for migraine and cluster headache.
The gammaCore device is a handheld VNS device that delivers electrical pulses through the skin. People use it at home by holding the device up against their neck.
During a 2-minute treatment session, the device sends a series of gentle electrical pulses into the skin, toward the vagus nerve. It can be used several times per day to treat migraine pain or on a regular basis to prevent migraine attacks before they start.
Because the vagus nerve is one of the main super highways between your brain and your body, stimulating it helps interrupt pain signals and relieve migraine pain.
It’s FDA cleared for the treatment and prevention of migraine in adults and adolescents over the age of 12. It’s also FDA cleared for the treatment and prevention of cluster headache in adults.
FDA-cleared vs. FDA-approved
It’s important to understand that many medical devices are FDA cleared and not FDA approved. This has to do with the way devices are regulated in the United States.
FDA approval is only required for class III medical devices, which are those that pose a significant risk to someone’s health, such as a pacemaker or an insulin pump. Devices that resemble other devices currently on the market that have a proven safety record are typically cleared rather than approved.
Noninvasive VNS devices such as the gammaCore are FDA cleared for the treatment and prevention of migraine and cluster headache.
VNS may not work for all individuals with these conditions, but clinical trials have shown that, for many people, it’s more effective than a sham (fake) device at treating migraine headaches.
It might be particularly helpful in cases where medications are ineffective in alleviating symptoms.
Potential side effects
The most common side effects of the gammaCore device are redness and discomfort at the application site, along with dizziness. These effects typically resolve quickly after the treatment session is over.
Another study also found mixed results from a noninvasive VNS device. While the treatment wasn’t found to be as effective as researchers hoped, it performed well against various points of measurement. For example, participants showed lowered pain intensity and pain relief at various points in the hours following treatment.
The 2020 study above suggests that while VNS is effective in migraine treatment, it may not work as well as medications. Still, due to its safety profile, VNS may be preferable over continuously using medications to treat migraine attacks.
One of the biggest drawbacks to noninvasive VNS therapy is that it’s not usually covered by insurance. This means it can be cost prohibitive for many people. The gammaCore device is available, with a prescription, for $450 for the first 3 months of treatment. After that, the 3-month refills can be purchased for $600.
Even in cases where VNS is FDA approved, such as for treatment-resistant depression, most insurance companies won’t cover it.
If VNS is something you want to try for migraine treatment, you may have one option to help lower the financial burden. If you have a flexible spending account or health savings account through work, you may be able to use those pretax dollars to pay some of the out-of-pocket costs.
Researchers believe that VNS therapy is safe for most people.
VNS therapy may be a good option for people who can’t take other medications to treat migraine attacks, such as pregnant people or people with heart conditions.
It may also be helpful in lowering medication overuse headaches. In fact, it’s thought that VNS may be used multiple times per day without any side effects.
Transcranial magnetic stimulation (TMS) is another type of noninvasive procedure that produces electrical currents in the brain. TMS is an in-office procedure where you wear a device on your head during each treatment session.
TMS is primarily used to treat mental health conditions, including depression and obsessive-compulsive disorder.
One study reported that TMS may help prevent migraine attacks in people with chronic migraine. Study participants reported fewer attacks, attacks that resolved quicker than usual, and lowered pain intensity.
It’s important to talk with a doctor about all migraine treatment options, including up-and-coming therapies such as VNS, as well as conventional treatments. Always ask a doctor before taking any supplements or herbs. These may interact with medications you take.
Conventional migraine treatment options may include abortive (rescue) treatments to stop a migraine attack and preventive medications, such as:
- Triptans: As perhaps the most common migraine medication, triptans work best when you take them as soon as you start feeling mild symptoms of migraine.
- Ergotamine drugs: This older class of medications targets migraine pathways to provide pain relief.
- CGRP antagonists: These are the newest group of medications approved for the prevention of migraine attacks.
- Botox: Botox injections are an FDA approved treatment for migraine prevention.
- Pain relievers: Also called analgesics, these work to alleviate pain in multiple areas of the body — not just pain from headaches.
While not technically a migraine treatment, hormone therapies like birth control pills may help people who experience migraine attacks at specific times during their menstrual cycles.
Additionally, a doctor may recommend a combination of the following strategies:
- keeping a log of your possible migraine triggers
- stress management
- losing weight if you have overweight or obesity
- magnesium or vitamin B2 supplements, if you’re deficient in these nutrients
- CoQ10 supplements
- butterbur supplements (for short-term use only)
Migraine is a chronic condition that doesn’t have a cure. Researchers are continuing to explore new treatments that help stop migraine attacks and prevent them from happening.
VNS is one such possibility. While VNS could potentially become a mainstream migraine treatment in the future, it’s not currently FDA approved for such purposes. The treatment measure is also expensive, and may not be appropriate if you have certain underlying conditions.
If you’re not seeing results from your current migraine treatment, talk with a doctor about other options you may have. It’s important to keep in mind that, just as migraine triggers may vary, treatment efficacy is highly individual. You may need to try multiple treatments before you find what works for you.