This study's objective was to evaluate the efficacy and tolerability of transcutaneous occipital nerve stimulation (tONS) in patients with migraine, and to explore whether different tONS frequencies influenced treatment effectiveness. This was a randomized, controlled trial of tONS for prevention of migraine. Patients were randomized to 1 of 5 therapeutic groups before treatment for 1 month. Groups A through C received tONS at different frequencies (2 Hz, 100 Hz, and 2/100 Hz), group D underwent sham tONS intervention, and group E received topiramate orally. The primary outcomes were the 50% responder rate and headache characteristics. A total of 110 patients completed the study. The 50% responder rate was significantly greater in the groups undergoing active tONS and topiramate, compared with sham-treated group. A significant reduction in headache intensity was noted in each test group compared with the sham group; the groups undergoing tONS at different frequencies did not differ significantly. From baseline to the 1-month treatment period, the tONS group with 100 Hz and topiramate group exhibited significant decreases in headache duration. We conclude that tONS therapy is a new promising approach for migraine prevention. It has infrequent and mild adverse events and may be effective among patients who prefer nonpharmacological treatment.

This article introduces a randomized, controlled trial to illustrate tONS as a new approach for prevention of migraine. It shows tONS is well tolerated and could be considered as a promising treatment for patients who prefer to nonpharmacological therapy.