Woman with migraine, looking away.
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There are new treatment options for people with migraines. Some help treat the pain of a migraine and others help reduce the attacks. Vagus nerve stimulation is one of the options being explored.

VNS is FDA-cleared for the treatment of migraines and cluster headaches, which is a big deal.

Here are the important information you need to know if you are curious about VNS for migraines. You will learn about how VNS devices 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 run from your brain to 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.

More convenient, non-pharmaceutical therapies have been created by new developments in VNS technology. These therapies are used for headaches.

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.

The device sends electrical impulses into the skin to the vagus nerve. It can be used to treat migraines several times per day, or to prevent attacks before they start.

The vagus nerve is one of the main highways between your brain and your body, and it helps interrupt pain signals and relieve headaches.

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

Many medical devices are not approved by the FDA. The way devices are regulated in the United States is what has to do with this.

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.

The FDA has cleared non-invasive VNS devices such as the gammaCore for use in the treatment of headaches.

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 helpful in cases where the medication is not effective.

A multi-center clinical trial showed that noninvasive VNS devices have a very good safety profile, and they’re more effective than sham devices in most cases. The study found that the VNS device resulted in complete pain relief for more people than the sham device within 2 hours of treatment. FDA clearance of the gammaCore device was based on these results.

Potential side effects

The most common side effects of the device are redness and dizziness. The effects usually resolve after the treatment is over.

Other studies, such as one from 2020, have shown that the treatment can successfully stop an in-progress migraine attack but that the treatment isn’t effective at preventing future migraine attacks.

One pilot study found that noninvasive VNS therapy helped lower the number of headache days in people with chronic migraine.

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.

VNS is effective in treating migranes, but it may not work as well as other drugs. VNS may be better for treating migraines than continuously using medications.

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 you want to try VNS for a treatment for migraines, you may have a choice of ways to lower the financial burden. If you have a flexible spending account or health savings account at work, you can use the money to pay for out-of-pocket costs.

Researchers believe that VNS therapy is safe for most people.

“VNS therapy is a good option for people who can’t take other medications to treat their migraines.”

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 is important to talk with a doctor about all the options for treatment of migraines. Before taking any supplements or herbs, ask your doctor. You may take these with your medication.

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:

Migraine is a chronic condition that can be treated. Researchers are looking at new treatments that can help stop attacks.

VNS is one of the possibilities. VNS is not currently approved for use in the treatment of migraines. The treatment measure is expensive and may not be appropriate if you have 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.