Cephalalgia, the official peer-reviewed medical journal of the International Headache Society, has published positive results of the American multicentric clinical trial ACME (Acute migraine therapy with external trigeminal neurostimulation: randomized controlled trial) implemented at Yale and Columbia Universities and at the Rowe Neurology Institute in Kansas.
The results of the study demonstrate the remarkable efficacy of the Cefaly medical device in treating migraine attacks compared to placebo. The proportion of patients with pain relief after one-hour and 24-hours was significantly higher in the Cefaly group compared with the placebo group. One hour after the start of the treatment, 29% of the patients were pain-free in the active group and 6% in the placebo group. In the active group, 79% of patients achieved significant pain relief at one hour, compared to 39% in the placebo group.
“We are excited by this publication which demonstrates the efficacy and safety of our technique, it led recently to the FDA clearance for the acute treatment of migraine attacks, and it will support our submission to health insurances for reimbursement in the USA and Europe, “says Pierre Rigaux, CEO of CEFALY Technology. “We have made significant technological progresses that have increased the efficacy for the acute treatment of migraine attacks. This is three times higher than what we had five years ago with the initial clinical trials. We now have an efficacy similar to triptans, which have long been considered the most effective drugs for acute migraine but without the risks and side effects. It is unique to have a non-invasive, non-drug, treatment that is as effective, if not better, than medication intended for migraine.”
Cefaly is a patented medical device and the first external cranial neurostimulator. This technology has been used for years in neurology, but was previously only available through implantable neurostimulators (similar to a pacemaker). The technological advances of Cefaly now offer a simple, lightweight, economical and comfortable device that provides migraine patients with a non-drug and non-invasive treatment.
Cefaly neurostimulation is applied to the upper branch of the trigeminal nerve, which is the main nerve involved in migraine. A self-adhesive electrode is placed on the forehead and the device is positioned on this electrode through a magnetic contact that enables precise micro-pulses to be transmitted through the skin to the nerve endings of the upper branch of the trigeminal nerve.