Anyone who has suffered from migraines knows that any relief is good. These debilitating headaches cause individuals to have pain, intense sensitivity to light, and sometimes nausea. Women are three times more likely than men to suffer from these headaches, which can be triggered by female hormonal changes during the month. Medication to treat these headaches does exist, but may have side-effects, such as being hard on one’s stomach, as well as other possible effects. Also, for some people, a single one of these headaches can last for days, which means more days of medication. Belgian researchers have developed a new portable transcutaneous electrical nerve stimulation (TENS) device, which has recently been FDA-approved for use in migraine relief, and it may also help with other issues.
This device, being marketed as Cefaly, is also being used in France, Canada, Australia and elsewhere. Researchers did a study involving 67 sufferers out of five Belgian headache clinics. To be eligible for the clinical trial, an individual had to suffer from at least two migraines per month. Enrolling neurologists involved in the study, as well as their patients, were “blind” or uninformed of conditions being used during the trial, making this a double-blinded study. This is the most objective type of clinical trial possible. The study was also random and sham-controlled.
Essentially, researchers had the enrolled neurologists from the five clinics choose migraine-suffering patients over the period of one month. At one month, subjects were randomly given, via their regular neurologist, a battery-operated Cefaly device, which looks like a plastic headband or thin pair of earphones that are worn across the forehead, resting on top of the ears, like sunglasses. An electrode is placed on the forehead, and electrical pulses are sent to the trigeminal nerve in the face. This nerve is responsible for facial sensation and has also been linked to migraines.
During the study, some of the devices emitted verum, or real electric pulses. Others emitted sham (or fake) stimulation. Neurologists at the involved clinics did not know whether their patient(s) was getting real stimulation or not, only the researchers had that information, which was not disclosed until the study was complete. To get FDA approval for a new device, studies would necessarily be blind, to prove (or disprove) true migraine relief as being indisputably linked to the use of the portable TENS machine.
The results are very hopeful for sufferers of these intense headaches. There was a clear reduction in number of headaches per month experienced by those who had verum stimulation, as opposed to the group that did not. Unfortunately, the device cannot reduce the intensity of migraines, but only reduce the number of times per month they occur. That said, the Cefaly device produces results within the same range as other headache treatments, including medications, but with no side effects. Even better, the device has three settings: the highest level is for use during migraine headaches, the next is a preventative setting (individuals are told to use Cefaly for 20 minutes per day) and the last is a setting used for relaxation. The last setting is being regarded as a possible alternative to anti-anxiety medications as well as sleep-aid medications. Time and further studies will reveal how successful the device is in these other areas of use, but for now, things look good.
Cefaly is available at Costco and other stores, and is still fairly expensive. Over 2,300 users in France and Belgium were surveyed about their level of satisfaction with the device, and just over half were happy with the product and will continue using it. Now that the FDA has approved the new device, migraine headache sufferers in the U.S. can use the battery operated, portable TENS machine to seek relief from their headaches. One of the few complaints about the device is that it made wearers sleepy during treatments.
By Julie Mahfood
Follow Julie Mahfood on Twitter @Julie11153717