Key clinical point: This real-world study confirms the safety, efficacy, and tolerability of remote electrical neuromodulation (REN) for long-term management of acute migraine, thus establishing REN as a valuable comprehensive treatment for this chronic disease.
Major finding : Overall, 74.1% and 26.0% of patients achieved consistent pain relief and pain freedom with REN, respectively, and 70.2% and 33.7% achieved functional disability relief and functional disability freedom, respectively. The incidence of device-related adverse events (dAE) was low, ie, 1.96%, which included 0.49% negligible, 1.22% moderate, and 0.24% mild AE. No severe AE were reported, and all patients continued treatment despite dAE.
Study details: This real-world evidence study included 409 patients with migraine treated for 12 consecutive months with REN, a self-administered device used at the onset of migraine headache or aura for acute treatment.
Disclosures: This study was funded by Theranica Bio-Electronics Ltd. M Weinstein and A Synowiec declared serving as consultants for Theranica. A Stark-Inbar and A Ironi declared being employees of and hold stock options in Theranica. A Mauskop had no conflicts of interest to disclose.
Source: Synowiec A et al. One-year consistent safety, utilization, and efficacy assessment of remote electrical neuromodulation (REN) for migraine treatment. Adv Ther. 2023 (Oct 19). doi: 10.1007/s12325-023-02697-6