Migraine headaches: Could nerve stimulation help? – Harvard Health Blog
Are you one of the 20 to 40 million people in the United States with migraines? If so, here’s some news to note: The FDA has just approved an over-the-counter nerve stimulation device that delivers mild electric shocks to the forehead to prevent or treat migraines.
It may seem like an unlikely way to treat migraines, so how did we come to this? And what is the proof that it works? Does this change the game? Craze? Or a treatment that falls somewhere in between?
Our changing understanding of what causes migraines
Blood vessels throughout the body, including those near the brain, narrow (constrict) and open (dilate) regularly, throughout the day. This is normal and it varies depending on the situation. Sleep, body temperature, physical activity and many other factors affect this activity of the blood vessels. Not so long ago, conventional wisdom held that migraines were caused by an exaggeration of this normal constriction and dilation of blood vessels. Experts believed that a trigger – like certain foods, stress, or a host of other factors – caused the blood vessels supplying pain-sensitive parts of the brain to suddenly constrict for a short time, then dilate, before breaking down. return to normal. We know that similar changes in blood vessels occur in other conditions such as Raynaud’s disease, so this was an interesting theory to explain the symptoms of migraine.
If migraines were due to excessive constriction and dilation of blood vessels in some people, this could explain why migraines are so common, temporary, and not associated with any permanent damage to the brain or other parts of the body. However, this theory is now considered false.
The current migraine theory
Current evidence (as described in this review) suggests that migraines begin with an abnormal activation of cells in the nervous system that spreads through the brain. This leads to inflammation near pain-sensitive parts of the brain, the release of chemical messengers, and changes in the sensitivity of the nerves that carry pain signals. Among the nerves involved are branches of the trigeminal nerve. This nerve provides sensation to areas of the face and controls the muscles that allow us to bite or chew. It is also linked to the pain-sensitive lining of the brain.
This evolving understanding of the potential causes of migraines has led to treatments focused less on changes in blood vessels and more on ways to block chemical messengers involved in pain signals. Triptan drugs, including sumatriptan (Imitrex and others) and rizatriptan (Maxalt), are good examples.
What about nerve stimulation for migraine headaches?
In recent years, studies have shown that electrical stimulation of the trigeminal nerve branches above the forehead can treat migraines and even prevent them. One such device, the Cefaly Dual, has been available by prescription to prevent migraines since 2014. It has just been approved as an over-the-counter device to prevent and treat migraines. The clearance differs from the FDA approval for the efficacy and safety of drugs and life-saving technologies like defibrillators; it allows manufacturers of medical devices to market a product because the FDA considers it safe and similar to other legally marketed products.
Evidence supporting nerve stimulation to prevent or treat migraine includes the following:
- A study published in 2013 recruited 67 people with migraines and compared electrical stimulation to sham stimulation for 20 minutes each day to prevent headaches. Over three months, fewer headaches and less need for migraine medication were seen in people receiving the real treatment. An improvement of at least 50% was noted in 38% of the study subjects, but in only 12% of the sham group.
- In a 2013 survey of more than 2,300 people using electrical stimulation for 20 minutes a day for two months to prevent migraine headaches, just over half said they were happy with the device and willing to buy it.
- A 2019 study randomly assigned 106 people with active migraines to receive electrical stimulation to the forehead or sham treatment (minimal electrical stimulation) for an hour. People receiving treatment reported an almost 60% reduction in pain, while those in the sham group only had a 30% reduction in pain.
What about the disadvantages?
None of these studies reported serious side effects related to electrical stimulation. Although a tingling sensation at the stimulation site is common, few perceive it to be painful or bothersome enough to stop treatment.
Cost is a consideration. The device’s manufacturer currently lists its standard price at $ 499 and says it’s not covered by health insurance. It comes with a 60-day money-back guarantee, which could help users decide if it’s worth the price.
Finally, there is the time commitment. To avoid migraines, users are advised to apply the device for 20 minutes every day. For the treatment of acute headaches, a 60-minute treatment is recommended.
The bottom line
This treatment has been around for at least 2014 and is definitely not a cure. So, electrical stimulation for migraine can hardly be considered a game changer for most migraine sufferers. But it seems to me that is not empty hype either. There is reasonable evidence that it is safe and at least quite effective.
The recent FDA action to make Cefaly Dual available without a prescription should make it more accessible. And, by all accounts, a moderately effective, drug-free way of treating migraine is a positive development. Hopefully, future studies of this device will clarify who is most likely to benefit from its use. But we need even better options. Advances in our understanding of how migraines develop and ongoing research should provide them.
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