Are you one of the 20 to 40 million people in the United States who have migraine headaches? If so, here’s some notable news: The FDA has just approved an over-the-counter nerve stimulation device that delivers light electric shocks to the forehead to prevent or treat migraine headaches.
This seems like an unlikely way to treat migraines. How did we get here? And what is the evidence that it works? Is that a game changer? Hype? Or a treatment that is somewhere in between?
Our changing understanding of what causes migraines
Blood vessels throughout the body, including those near the brain, periodically narrow (narrow) and open (widen) throughout the day. This is normal and varies depending on the situation. Sleep, body temperature, physical activity, and many other factors influence this blood vessel activity. Not so long ago, conventional wisdom held that migraines were due to an exaggeration of this normal narrowing and widening of the blood vessels. Experts believed that a trigger – like certain foods, stress, or a host of other factors – suddenly narrowed the blood vessels that supply pain-sensitive parts of the brain for a short time and then expanded before returning to normal. We know that similar blood vessel changes occur in other conditions such as Raynaud’s disease. Hence, this was a compelling theory to explain migraine symptoms.
If migraines in some people are due to excessive narrowing and widening of the blood vessels, this could explain why migraines are so common, temporary, and not associated with permanent injury to the brain or other parts of the body. However, this theory is now believed to be incorrect.
The current theory of migraines
Current evidence (as detailed in this review) suggests that migraine headaches begin with abnormal activation of cells in the nervous system that spread to the brain. This leads to inflammation near pain-sensitive parts of the brain, the release of chemical messengers, and changes in the sensitivity of nerves that carry pain signals. Under the nerves involved are branches of the trigeminal nerve. This nerve sensitizes areas of the face and controls muscles that allow us to bite or chew. It is also related to the pain-sensitive lining of the brain.
This evolving understanding of possible causes of migraine headaches has led to treatments that focus less on changes in blood vessels and more on ways to block chemical messengers that are involved in pain signals. Triptan drugs, including sumatriptan (Imitrex and others) and rizatriptan (Maxalt), are good examples.
What about nerve stimulation for migraines?
In recent years, studies have shown that electrical stimulation of branches of the trigeminal nerve above the forehead can treat and even prevent migraine headaches. One such device, the Cefaly Dual, has been prescription-only since 2014 to help prevent migraine headaches. It has just been approved as an over-the-counter device for the prevention and treatment of migraine headaches. The clearance differs from FDA approval for efficacy and safety of drugs and life-saving technologies like defibrillators. It enables medical device manufacturers to market a product as the FDA deems it safe and similar to other legally marketed products.
The evidence supporting nerve stimulation to prevent or treat migraines includes the following:
- A study published in 2013 enrolled 67 people with migraines and compared electrical stimulation to sham stimulation for 20 minutes a day to prevent headaches. Over three months, fewer headaches and less need for migraine medication were seen in those on actual treatment. An improvement of at least 50% was found in 38% of the subjects, but only in 12% of the sham group.
- In a 2013 survey of more than 2,300 people who used electrical stimulation to prevent migraines for two months for 20 minutes a day for two months, just over half said they were satisfied with the device and were ready to buy it.
- In a 2019 study, 106 people with active migraine headache were randomly given an hour of electrical stimulation through the forehead or a dummy treatment (minimal electrical stimulation). Those who received treatment reported a pain reduction of almost 60%, while those in the sham group only had a pain reduction of 30%.
What about the cons?
None of these studies reported serious side effects related to electrical stimulation. While tingling at the stimulation site was common, few found it painful or disturbing enough to stop treatment.
Cost is a consideration. The manufacturer of the device currently lists its standard price as $ 499 and states that it has no health insurance. It comes with a 60-day money-back guarantee that users can use to decide if it’s worth the price.
Finally, there is the time commitment. To prevent migraines, the user is advised to use the device for 20 minutes a day. A 60-minute treatment is recommended for the treatment of acute headaches.
The final result
This treatment has been around since at least 2014 and is certainly not a cure. Therefore, electrical stimulation in migraines can hardly be viewed as a game changer for most migraineurs. But it doesn’t seem like empty hype either. There is reasonable evidence that it is safe and at least reasonably effective.
The FDA’s recent move to make the Cefaly Dual available without a prescription should make it more accessible. And in all respects, modestly effective, drug-free treatment for migraines is a positive development. Hopefully, future studies of this device will clarify who is most likely to benefit from using it. But we still need better options. Advances in our understanding of how migraines develop and ongoing research should provide them.
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