New Device for Migraine Headaches Approved By FDA

Michelle Ristuccia

Migraine headache sufferers may find hope in Cefaly, a new medical device for treating migraines approved by the FDA in a press release issued March 11, 2014. The device rests on the patient's forehead using a self-adhesive electrode, and is battery powered and easy to use. Cefaly is a TENS unit which sends painless electrical impulses to the trigeminal nerve in the face. The trigeminal nerve is often involved in triggering migraines.

Migraine headaches can debilitate sufferers with light and noise sensitivity, nausea, and throbbing pain, often on one side of the head. Migraines rank in the top 20 of most disabling medical illnesses, according to the Migraine Research Foundation. Studies show that 18 percent of women and 6 percent of men suffer from migraines, and 10 percent of school-aged children.

One older theory says that migraines are caused by blood vessel changes in the brain, and a newer theory states that nerves and brain chemicals are involved. Migraines can be triggered by blood pressure and hormonal changes, especially estrogen, and genetics also play a large factor.

The TENS unit may be treating the symptoms and not the cause. However, for the 4% who suffer daily chronic migraines 15 times or more a month, any relief is welcome. Over 90% of sufferers cannot function normally during a migraine, which can impair work and social life. Depression, anxiety, and sleep disturbances are common for migraine headache sufferers. Reducing the frequency of migraines with the newly approved TENS unit may improve quality of life for migraine sufferers.

TENS units (Transcutaneous Electrical Nerve Stimulation) are used to treat many different types of pain, even muscle soreness. TENS units often involve patches placed on the skin rather than the newer headband design. In either case, the TENS unit delivers low frequency electrical impulses that stimulate the nerves just under the skin. This stimulation can disrupt the pain signals being sent to the brain, which is important not only for immediate relief but for breaking feedback loops, such as swelling, that ultimately cause more pain. TENS units stimulate blood flow and endorphins. TENS units are non-addictive, unlike narcotics and hormonal treatments commonly used for migraines.

Christy Foreman, director of the Office of Device Evaluation at the FDA's Center for Devices and Radiological Health, says the FDA is hopeful about the Cefaly device. "This may help patients who cannot tolerate current migraine medications for preventing migraines or treating attacks."

FDA approval of Cefaly was based on a scientific study involving 67 people and a patient satisfaction survey of 2,313 Cefaly users in France and Belgium. 53% of Cefaly users were satisfied with the device. Cefaly does not completely prevent migraines.

This is the first TENS unit approved by the FDA for use in preventing pain.

[Photo credit:]