The FDA Has Approved Two Stimulator Devices for Migraine Pain

Each year in the U.S., over 37 million people, including veterans, suffer from migraines. Over 90 percent say that they can’t function during a migraine attack, and many miss work because of it. While no migraine is the same for everyone, people with migraines often suffer similar symptoms: nausea, severe sensitivity to sound and light; pounding and throbbing head pain; and the need to lie down in a dark, quiet room.

The causes of migraines aren’t known, but these types of headaches can sometimes be triggered by allergies, strong smells, bright or flickering lights, loud noises, anxiety, fatigue, low blood sugar, and certain types of food and drink. For veterans, migraines may be service related—started or aggravated by an event or incident that took place during their military service. Some veterans The Word Migraine Being Erased by a Yellow Pencilexperience serious headaches, but are not aware that they are, in fact, migraines. It can sometimes be difficult to accurately identify migraines, and often they’re misdiagnosed as tension or sinus headaches.

Most migraine sufferers have used medication and other therapies to address their headache pain. But in 2013, the U.S. Food and Drug Administration (FDA) approved the marketing of a noninvasive prescription device for the preventative treatment of migraines called “Cerena”—a transcranial magnetic stimulation (TMS) device. This was followed in 2014 by the approval to market another device called “Cefaly”—a transcutaneous electrical nerve stimulation (TENS) device for use prior to the onset of pain associated with migraines.

What are Cerena and Cefaly, and How Do They Work?

For many years, migraine treatment was focused on medication. Today, however, there’s been more research and focus on neurostimulators for the treatment of these severe headaches. Two recent neurostimulators are Cerena and Cefaly.

Cefaly

According to the FDA’s Center for Devices and Radiological Health, Cefaly is an alternative to medication for preventing migraines. Migraine sufferers who can’t tolerate the medications currently on the market or who don’t want to take drugs for their pain now have another option for preventing their migraines or treating attacks. Here is important information about Cefaly and how it works:

  • It’s a battery-powered, portable device that you get by prescription.
  • It looks like a headband that you might wear around your forehead and over your ears.
  • Patients use a self-adhesive electrode to position the Cefaly in the center of their forehead.
  • The device stimulates branches of the trigeminal nerve—associated with migraine headaches—by sending an electric current to the skin and underlying body tissues.
  • Patients may experience a massage-like sensation or tingling where the electrode is attached to their forehead.
  • Patients 18 years or older can use this device once a day for 20 minutes.

Cerena

Of those people who suffer migraines, approximately one-third experience an aura—dazzling flashes of light, visual blind spots, a zigzag of sparkling light, or a tingling sensation in a leg or an arm—that occurs just before a migraine attack. Cerena is the first FDA-approved device to help relieve migraines preceded by an aura. Here is some important information about this magnetic stimulator:

  • It’s a small, boxlike unit available through prescription only.
  • Patients hold the device against the back of their head and press a button.
  • Pressing this button releases a pulse of magnetic energy.
  • The pulse stimulates the “occipital cortex” in the brain, and this may decrease or stop the pain of a migraine.

Both stimulators are tools in the fight to find relief for migraine pain. Patient use over the last few years indicates that it’s possible for both stimulators to decrease migraine pain without medication. 

Side Effects of Both Devices are Limited

The FDA states that the side effects of both devices are limited. They include skin irritations, a feeling of sleepiness or fatigue after using the device, and pain or discomfort after applying the device. Most of the issues weren’t reported frequently, and they were easily resolved. Presently, the effectiveness and safety of these devices aren’t yet known for pregnant women, children, and people who wear pacemakers.

If you suffer from migraine headaches and found this blog article helpful, share it with your friends and family on Facebook, Twitter, and Google+.

 

Sean D. Cuddigan
SSA and VA Disability Attorney in Omaha, Nebraska
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