A new clinical trial has shown that the Cefaly migraine treatment device is safe and effective for migraine prevention, according to manufacturer Cefaly Technology.
Cefaly is an external trigeminal nerve stimulation device (e-TNS) that is magnetically connected to a self-adhesive electrode placed on the forehead. It sends micro-impulses through the electrode to the upper branch of the trigeminal nerve to either relieve or prevent a migraine headache. The “prevent” setting is intended for people who have three or more migraine attacks per month and need treatment to reduce the frequency of episodes, according to Seraing, Belgium-based Cefaly Technology, which has U.S. operations in Wilton, Conn.
The trial assessed 80 adult patients who had a history of 15 or more headache days per month and met International Classification of Headache Disorder-3 beta for chronic migraine. Seventy-three patients were included in a baseline period and 58 entered the treatment period.
Results showed that headache days were reduced by an average of 3.12 days (16%) and acute medication intake decreased by 30% (-8.11) during the third month of treatment, compared to the baseline. Patients were required to wear the Cefaly device at least once a day for 20 consecutive minutes. The results show an improvement in both the frequency of headache days and in overall acute medication intake when used as prescribed. The company said that the two reported adverse events were categorized as minor and fully reversible.
The open-label trial was conducted at the University of Colorado, Anschutz Medical Campus in Aurora, Colorado. Results were published the International Headache Society journal Cephalalgia.
“We are continually excited by the positive findings in trials that demonstrate the safety and efficacy of Cefaly,” said Cefaly US medical director Dr. Mark Harman in a news release. “This means that patients with a history of persistent and debilitating headaches can benefit from our easy to use treatment, reduce their reliance on medication, and experience significantly less side effects.”
Previous trials by the same principal investigator demonstrated the efficacy and safety of Cefaly for treating migraine attacks compared to placebo, the company said.
“We now have a device with efficacy rivaling triptans, a standard of migraine treatment for acute migraine but without the risks and side effects commonly associated with drugs,” Harman said. “Some patients don’t want to take medication and others simply cannot tolerate it. These trial results give Cefaly devices legitimacy as an adjunctive, complete, or alternative option to physicians and patients, that is significant for the migraine treatment field.”
