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Electrical Nerve-Stimulation Device Prevents Migraine
In a new study, Cefaly, the first FDA-approved transcutaneous electrical nerve-stimulation device for use before the onset of migraine pain, provided relief for 81% of migraine patients who used it.
The study, conducted in Italy, enrolled 24 patients with migraine without aura who were experiencing a low number of attacks per month and who had taken migraine-preventive drugs. The primary outcome measures were the reductions in migraine attacks and in the number of migraine days per month. The investigators also analyzed the percentage of patients with at least a 50% reduction in the rate of monthly migraine attacks and in the number of migraine days. Secondary outcome measures included the reduction of headache severity during migraine attacks, the Headache Impact Test 6 (HIT-6) rating, and the monthly use of rescue medication. The study was conducted from January 2013 to October 2014.
Between run-in and the second month of treatment, all primary and secondary endpoints were met. The investigators observed a statistically significant decrease in the frequency of migraine attacks (P < 0.001) and in the number of migraine days (P < 0.001) per month. They also noted at least a 50 % reduction in the number of monthly migraine attacks and in the number of migraine days in 81% and 75% of patients, respectively. Moreover, the study results showed a statistically significant reduction in the average pain intensity during migraine attacks (P = 0.002) and in the HIT-6 rating (P < 0.001), as well as a significant reduction in the use of rescue medications (P < 0.001).
The results were published in the Journal of Headache and Pain.
Most headaches and migraines involve the trigeminal nerve, which ends at the exit of the eye socket, underneath the skin of the forehead. The Cefaly device is connected to an adhesive electrode positioned on the forehead. Through the electrode, the device generates micro-impulses, which stimulate the nerve endings of the trigeminal nerve, thereby producing a sedative effect. Regular repetition of this effect helps reduce the number of attacks of migraine, according to the device’s maker, Cefaly Technology. Each electrode can be used up to 20 times.
Cefaly was approved by the FDA in March 2014 for use under prescription.
Sources: PR Newswire; August 26, 2015; Journal of Headache and Pain; July 22, 2015; and Cefaly Technology; 2015.