Over half of the migraine sufferers who tried a neurostimulation device to prevent headaches were so satisfied at the conclusion of a 40-day study that they decided to purchase the device.
The Cefaly stimulator, which looks like a space age tiara, delivers transcutaneous supraorbital nerve stimulation (tSNS) to the supraorbital nerve in the brain. Highly precise impulses are transmitted through an electrode to the nerve endings of the upper branch of the trigeminal nerve.
Over 2,300 migraine sufferers volunteered to try the device in a study published online in the Journal of Headache and Pain. The participants lived in Belgium, France or Switzerland; three countries where they could rent or buy the Cefaly stimulator over the Internet without a medical prescription.
Participants were advised to perform tSNS at least once daily to achieve a preventive anti-migraine effect. Each session should last 20 minutes, so at the end of 40 days the recommended minimum time of use was 800 minutes. A built-in monitoring system recorded the total time of tSNS use in subjects who returned the device to the manufacturer.
At the conclusion of the study, over 54% of the participants were satisfied with tSNS treatment and were willing to purchase the device. The remaining 46% of the Cefaly renters were not satisfied and returned it – although a compliance check found that many had not used the device for the recommended time and some never even turned it on.
Side effects such as fatigue, insomnia, and pain were reported by about 4% of the patients.
Another recent study of the Cefaly stimulator on 67 migraine patients found that wearing it for 20 minutes a day reduced the number of migraines just as effectively as migraine drugs or other types of migraine therapy. The number of days they suffered migraine attacks decreased from an average of 6.9 days to 4.8 days per month. Patients also had slightly less severe headaches and their use of anti-migraine drugs declined significantly.
About 31 million adult Americans suffer from migraine. It affects three times as many women as men. In addition to headache pain and nausea, migraine can also cause vomiting, blurriness or visual disturbances, and sensitivity to light and sound.
Cefaly is the first medical device to offer external cranial neurostimulation, which until now has only been available through implantable neurostimulators. The Belgium based company that makes the device hopes for FDA approval in the coming months.
Last month the FDA approved the marketing of the first transcranial magnetic stimulation (TMS) device for the relief of pain caused by migraine preceded by an aura. Studies show the device is effective about a third of the time.
The Cerena TMS is a handheld prescription device meant to be used after the onset of migraine pain. The device is placed at the back of the head to release a pulse of magnetic energy to the occipital cortex in the brain, which may stop or lessen the pain associated with migraine headaches.