THURSDAY, April 5, 2018 -- Self-administered magnetic pulses from a hand-held device may help head off debilitating migraines, researchers report.
This new way to approach migraine headaches is called "single pulse transcranial magnetic stimulation," or sTMS. Neurologists and psychiatrists have long used the technology to diagnose and treat patients.
The U.S. Food and Drug Administration had already approved the eNeura SpringTMS device to treat the kind of in-progress migraines that are preceded by an "aura" of flashing lights and visual disturbances.
Having found that the device can also prevent up to half of all migraines from occurring in the first place, the FDA has now approved it for both prevention and treatment.
"The brain of a person with migraine, which is a neurologic disease with a genetic basis, is hyperexcitable," said lead researcher Dr. Amaal Starling. "In general, if we can reduce hyperexcitability, we can stop and/or prevent migraine attacks."
Transcranial magnetic stimulation does that by using energy created by a magnet to "change the electrical environment of neurons or brain cells," she explained.
Starling is an assistant professor of neurology with the Mayo Clinic in Scottsdale, Ariz.
She led a team that studied the effectiveness of the device, and the findings were published in the March issue of the journal Cephalalgia. The research was funded by eNeura, Inc., manufacturer of the device.
Migraines are the sixth-leading cause of global disability, affecting roughly 1 in 10 individuals. That includes an estimated 38 million people in the United States. The headaches are three times more common among women than men, according to the U.S. National Institute of Neurological Disorders and Stroke.
Migraines are marked by intense pulsing or throbbing pain in one part of the head, sometimes accompanied by nausea, vomiting and/or sensitivity to light and sound.
There's no known cure. Migraines are sometimes treated with drugs designed to target epilepsy, depression and high blood pressure. Injections of Botox, or botulinum toxin A, stress management and relaxation techniques and exercise can help treat them.
To see if sTMS could prevent migraines, the researchers enlisted 263 patients between the ages of 18 and 65. Each kept a headache diary for one month. Some experienced auras with their headaches, others did not.
The participants were trained to use the sTMS device at home. It's roughly 3 inches by 9 inches in size and weighs about 3 pounds.
The patients were instructed to hold the device to the back of their head and press a button to administer the magnetic pulse. Migraine.com, a health forum website, says the sensation is mild but startling, though some find it uncomfortable.
To prevent migraines, the participants were told to give themselves four magnetic pulses -- each lasting less than a minute -- in the morning and four more at night. Three sessions of three pulses every 15 minutes were prescribed for those with headaches in progress.
The result? After three months, patients averaged three fewer headaches per month, regardless of migraine type. And 46 percent saw their headache frequency reduced by at least half.
Starling described the treatment as "well-tolerated." As headache frequency dropped, so did the use of migraine medications, she added. She would not estimate cost of the device, but predicted that FDA clearance would lead to broader insurance coverage.
Dr. Richard Lipton is director and vice chairman of neurology at Albert Einstein College of Medicine and director of the Montefiore Headache Center, both in New York City. He took part in the research that led to both FDA approvals.
Lipton said the aim is giving migraine sufferers more treatment options.
"Some people do not want to take drugs and prefer a device. Some people [also] do not respond to available drugs, or have side effects that limit their use," he said.
"For patients who prefer not to take drugs and for patients who have side effects or lack of medication response, this is an important [new] option," Lipton said.
There's more on migraines at U.S. National Institute of Neurological Disorders and Stroke.
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