It looks like something designed for Star Wars, a sleek forehead tiara with a jewel mounting in the middle. Actually, it’s meant to get rid of migraine headaches. The Cephaly, produced by Roxon (St. Leonard, Quebec Canada) uses an approach with a long name, transcutaneous electrical nerve stimulation, shortened to TENS, which has a decade or two of history but at least up to now, limited success. A new study, from the Headache Research Unit at the University of Liege (Belgium) and published in the journal Neurology, provides reason for another look.
As those who suffer with migraines know, these headaches are difficult to treat – or even to alleviate the pain. They often do not respond to common over-the-counter drugs such as aspirin or acetaminophen. In some cases, they don’t even respond to prescription drugs. The exact cause(s) of migraines are not known, or more to the point, doctors are aware of multiple possible causes – a mixture of genetic and environmental factors may be at work.
Whatever actually causes migraine headache in particular individuals, it is most often associated with abnormal control of pain neurons in the trigeminal nucleus of the brainstem. These neurons connect pain sensitive nerves in the body to the brain.
The concept behind Cephaly is, simplified, to block out migraine pain with stimulation of nerves. That’s where the long terminology comes in: transcutaneous (through the skin) electrical (pulses of low wattage electricity) nerve stimulation (directed at specific nerves or nerve clusters).
The approach is very similar to the electrical stimulation given by physical therapists to treat muscle pain. Only in this case, the stimulation is to the supraorbital nerve, the nerve that connects the forehead area to the trigeminal nerve. The supraorbital nerve is often associated with migraine pain, as tics and other pains of the face are common for people suffering with migraines.
The Cephaly device, placed over the center of the forehead and connected to the skin with a small electrode, generates high frequency but low-power pulses that penetrate into the head, far enough to affect the supraorbital nerve. While the precise effect of the stimulation isn’t known, the researchers believe the Cephaly device sets up a stronger nerve response, through the supraorbital nerve, than the pain nerves leading to the trigeminal nerve. It could be said that this stronger nerve response cancels out the progression of migraine pain, or possible it ‘confuses’ the brain in its interpretation of the pain signals.
Either way, there seems to be results, at least for some patients. The Belgian study, conducted on 67 people who had an average of four migraine attacks per month, received by random selection (Phase I clinical trial) either Cephaly stimulus for 20 minutes a day for three months, or as a control group they used a Cephaly that produced only weak (non-effective) vibrations for the same amount of time.
Of the 34 patients in the trial who used the real Cephaly device, 38 percent had at least a 50 percent reduction in the monthly frequency of days with a migraine headache. This compared to 12 percent among those with the non-effective Cephaly devices who had the same results (presumably due to the placebo effect). For the active group, the number of days with migraine decreased from 6.9 to 4.8 days per month.
The Cephaly treatment required about a month to take effect. The best part, other than some success in reducing migraines, is that the Cephaly produced no known side effects.
There were important limitations to this study. As a Phase I clinical trial, the number of participants was relatively small, moreover, none of these participants suffered from severe cases of migraine. The effect of the Cephaly aims to reduce the occurrence of migraines, not treating the pain of migraines during an attack. The Cephaly device is approved for use in parts of Europe and Canada, but not yet in the United States. The device costs approximately 350 Euros (about $450 U.S.)