June 27, 2008 -- A lightweight, handheld device helps migraine sufferers zap away pain, sometimes within two hours, according to a new study.
Called a transcranial magnetic stimulation device (TMS), it transmits magnetic pulses that interrupt the "hyper-excitability" of neurons in the brain, which some experts believe is to blame for launching the migraine.
"This is based on a new understanding of how migraines start," says Yousef Mohammad, MD, a professor of neurology and principal investigator of the study at Ohio State University Medical Center, Columbus. The findings will be presented this week at the annual meeting of the American Headache Society in Boston.
About 35 million Americans suffer from migraines, according to the American Headache Society.
Migraine Zapper vs. 'Sham' Treatment
Mohammad and his colleagues randomly assigned 201 migraine sufferers, ages 18 to 68, to a treatment group or a sham treatment group at 16 different study centers.
Members of both groups took home the device, which is now portable and weighs about 3 pounds. It looks like a box with two handles on either side.
Participants didn't know if they had the device that emitted magnetic pulses or the devices that looked identical and buzzed and vibrated like the real machine but did not emit the pulses.
All had been diagnosed with migraine with aura -- the changes in vision and light sensitivity and other symptoms that about one in five migraine patients experience before the headache pain. They had a history of one to eight migraines with aura per month. To enter the study, they couldn't overuse headache medicines.
When they noticed the aura coming on, they were told to grasp the handles and apply the device to the back of their heads, then to administer two pulses by pushing a button twice.
They recorded their responses and pain levels in an electronic diary when they treated themselves and again at 30 minutes, one hour, two hours, 24 hours, and 48 hours later. A total of 164 patients finished the study, recording their responses for up to three attacks over three months.
At the two-hour mark, 39% of the patients who used the real machine were pain free, compared with just 22% using the sham treatment device. The difference is very significant, Mohammad tells WebMD.
The rates of headache-associated symptoms such as light sensitivity and nausea in the treated group were equal to or lower than the rates reported by the sham treatment group.
In a previous study of 43 patients treated at a medical office for their migraines with aura, Mohammad found that 74% who got the pulses had no pain or mild pain two hours later, but just 45% of those who got sham treatment did. He reported those results two years ago at the American Headache Society meeting. The more recent study examined only pain elimination, not reduction.
Migraine Zapper: How It Works
The zapper is believed to stop a migraine before it takes hold. "The migraine starts in nerve cells in the back of the head," Mohammad says. "There is a hyper-excitability in an area in the brain."
The aura, experts believe, is the result of this abnormal electrical activity or hyper-excitability, spreading from one nerve cell to the others. The magnetic stimulation device interrupts this process.
Migraine Zapper: 'Exciting' Treatment
"It seems to be effective for migraine with aura,'' says Roger Cady, MD, headache specialist and family practice physician in Springfield, Mo., who is familiar with the device and the study. "Whether it will be effective for migraine without aura is yet to be determined."
If it is approved, Cady says he will review more data before deciding to recommend it to patients.
"I think it's an exciting way of treating migraines. If it holds true, it would be a wonderful thing for patients."
Device for Migraine: What's Next?
The hope is to have the device on the market within six months, says Mohammad, who serves on the board of directors for NeuraLieve, which funded the study and provided the equipment. Whether patients will need ongoing treatments or simply a series of sessions to get rid of migraines is not known, he says.
In a prepared statement, the company says it is in the process of getting clearance from the FDA to market the device, which it refers to as the Neuralieve TMS Therapy System. The hope is to make it available to doctors to prescribe to patients.
The cost of the device is not yet known. Earlier versions of the device that use repetitive pulses instead of two brief pulses have been used for brain-mapping and to treat depression, Mohammad says.