Efficacy and safety of remote electrical neuromodulation in migraine: a comprehensive systematic review and meta-analysis

Abstract

Background: Migraine is a disabling disorder characterized by recurrent severe headache attacks. Non-invasive neuromodulation can be employed in the prevention and/or acute treatment of migraine. Remote electrical neuromodulation (REN), a type of non-invasive neuromodulation, is an effective and safe at-home treatment for migraine. It stimulates peripheral nerves in the upper arm to trigger conditioned pain modulation. Methods: We searched PubMed, Web of Science, Scopus, and the Cochrane Library for clinical trials and observational studies that assess the efficacy of REN in patients with migraine attacks. Statistical analysis was performed using Review Manager version 5.4.1 and Open Meta Analyst software. Results: Our study included 12 studies with 9912 migraine patients. In the single-arm meta-analysis, 64% (95% CI: 0.62 to 0.65), and 22% (95% CI: 0.213 to 0.237) of patients experienced a reduction in pain and pain-free status at 2 h, respectively. Additionally, 59% (95% CI: 0.548 to 0.637), and 54% (95% CI: 0.471 to 0.609) of patients reported sustained pain relief and sustained pain-free status at 24 h, respectively. Marked functional improvement was achieved in 59% (95% CI: 0.577–0.607) of patients within 2 h post-treatment with REN, and 54.6% (95% CI: [0.519 to 0.574]) reported the disappearance of their most bothersome symptom (MBS). Device-related adverse events were reported in 0.4% (95% CI: 0.003 to 0.005) of patients. In double arm meta-analysis, pain-free status at 2 h had an odds ratio (OR) of 2.77 (95% CI: 1.63 to 4.71). While device-related adverse events had an OR of 1.45 (95%CI: 0.42 to 4.94). Trial registration: CRD42024596712