App-based self-administered biofeedback for the prevention of episodic migraine: A randomized controlled trial

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.