Single-pulse transcranial magnetic stimulation for acute treatment of migraine with aura: a randomised, double-blind, parallel-group, sham-controlled trial

Summary

Background Migraine with aura presents a significant clinical challenge, with limited acute treatment options. Single-pulse transcranial magnetic stimulation (sTMS) has emerged as a potential therapeutic modality. This study aimed to evaluate the efficacy and safety of a portable sTMS device for acute treatment in patients with migraine with aura. Methods In a randomized, double-blind, sham-controlled trial across 18 U.S. centers, 267 adults aged 18–68 with a history of migraine with aura participated. Inclusion criteria required visual aura preceding at least 30% of migraines, followed by moderate or severe headache in over 90% of attacks. Participants were randomized to receive either active sTMS or sham stimulation during acute migraine episodes. The primary outcome was pain freedom at 2 hours post-treatment. Findings and Implications The study demonstrated that active sTMS significantly improved pain freedom compared to sham treatment. Additionally, patients reported reduced migraine-associated disability and a lower need for rescue medication. The device was well-tolerated, with a safety profile comparable to sham treatment. These findings suggest that sTMS is a promising non-pharmacological intervention for acute migraine with aura, offering a novel option for patients seeking alternatives to traditional pharmacotherapy. Further research is warranted to confirm these results and explore long-term efficacy.