Acute treatment of migraine with external trigeminal nerve stimulation: A pilot trial

Abstract

Objective:The main objective of this study was to obtain efficacy data for external trigeminal nerve stimulation (e-TNS) in the acute treatment of migraine in patients using the device at home.Methods:This was a single-center, open-label trial conducted at the Rochester Clinical Research Center (Rochester, NY, USA). Patients who met International Classification of Headache Disorders, Third Edition, criteria for migraine with and without aura for ≥1 year and having between 2 and 8 moderate or severe attacks per month were recruited. Patients were advised to treat one migraine attack of moderate to severe intensity that started less than 4 h earlier and was not treated with an acute migraine medication, with a 2-h e-TNS session. Primary outcome measures were pain freedom at 2 h and most bothersome migraine-associated symptom (MBS) freedom at 2 h. Secondary outcome measures were pain relief at 2 h, the absence of migraine-associated symptoms at 2 h, the use of rescue medication between 2 and 24 h, and sustai...