Amalie Christine Poole, Anker Stubberud, Melanie Rae Simpson, Lise Rystad Øie, Erling Tronvik, Espen Saxhaug Kristoffersen, Marte-Helene Bjørk, Iben Cornelia Keim Larsen, Kjersti Grøtta Vetvik, Nina Bäcklund, Joakim Høgsteggen Østhus, Joan Crespi, Oda Vardenær Lunder, Andrej Netland Khanevski, Ane Bakke Øvrevik, Alexander Olsen, Mattias Linde, Øyvind Salvesen, Tore Wergeland
AimTo evaluate the efficacy and safety of a fully self-administered, app-based biofeedback intervention for the prevention of episodic migraineMethodsThis open-label, randomized, waitlist-controlled multicenter trial included adults with episodic migraine assigned to 12 weeks of daily biofeedback or a waitlist control. The primary outcome was change in monthly migraine days (MMDs) from baseline to weeks 9-12. Secondary outcomes included migraine intensity, acute medication use, and migraine-specific quality of life (MSQ v2.1). Statistical analyses were performed according to the intention-to-treat principle by a statistician masked to treatment assignment.ResultsOf 1113 individuals screened, 279 participants (mean [SD] age, 41 [10] years; 92% women) were randomized to the intervention (n = 140) or waitlist control (n = 139). Baseline MMDs were 4.8 (2.4) and 4.6 (2.3) in the intervention and control groups, respectively. During weeks 9-12, the estimated reduction in MMDs was 0.9 days (95% CI, -1.4 to -0.5) in the intervention group and 0.0 days (95% CI, -0.5 to 0.4) in the control group (between-group difference, 0.9 days; 95% CI, 0.3 to 1.5; P = 0.002). Participants receiving biofeedback also showed greater improvements in MSQ v2.1 total scores (mean difference, 5.3 points; 95% CI, 2.1 to 8.6; P = 0.001). Nine device-related adverse events occurred, all with mild severity.ConclusionApp-based self-administered biofeedback was associated with a statistically significant reduction in migraine frequency and improved quality of life, with a favorable safety profile.