Biofeedback Treatment App for Pediatric Migraine: Development and Usability Study.

OBJECTIVE: The objective of this study was to develop and investigate the usability of a biofeedback treatment smartphone app for adolescent migraine sufferers. BACKGROUND: Biofeedback is effective in treating pediatric migraine. However, biofeedback is not widely used due to the necessity of a trained therapist and specialized equipment. Emerging digital technology, including smartphones and wearables, enables new ways of administering biofeedback. METHODS: In a prospective open-label development and usability study, 10 adolescent migraine sufferers used a newly developed biofeedback app with wearable sensors that measured their muscle tension, finger temperature, and heart rate. Three iterative rounds of usability testing, including a 2-week home testing period, were completed. A biofeedback algorithm, combining and optimizing the 3 physiological modalities, and several algorithms for sham-treatment were created. Usability was evaluated statistically and summarized thematically. RESULTS: Five of ten participants completed all 3 rounds of usability testing. A total of 72 biofeedback sessions were completed. Usability scoring was consistently high, with median scores ranging from 3.5 to 4.5 on a 5-point scale. The biofeedback optimization algorithm correlated excellently to the raw physiological measurements (r = 0.85, P < .001). The intervention was safe and tolerable. CONCLUSION: We developed an app for young migraine sufferers to receive therapist-independent biofeedback. The app underwent a rigorous development process as well as usability and feasibility testing. It is now ready for clinical trials.

Biofeedback as Prophylaxis for Pediatric Migraine: A Meta-analysis.

CONTEXT: Migraine is a common problem in children and adolescents, but few satisfactory prophylactic treatments exist. OBJECTIVE: Our goal was to investigate the pooled evidence for the effectiveness of using biofeedback to reduce childhood migraine. DATA SOURCES: A systematic search was conducted across the databases Medline, Embase, CENTRAL, CINAHL, and PsychINFO. STUDY SELECTION: Prospective, randomized controlled trials of biofeedback for migraine among children and adolescents were located in the search. DATA EXTRACTION: Data on reduction of mean attack frequency and a series of secondary outcomes, including adverse events, were extracted. Risk of bias was also assessed. RESULTS: Forest plots were created by using a fixed effects model, and mean differences were reported. Five studies with a total of 137 participants met the inclusion criteria. Biofeedback reduced migraine frequency (mean difference, -1.97 [95% confidence interval (CI), -2.72 to -1.21]; P < .00001), attack duration (mean difference, -3.94 [95% CI, -5.57 to -2.31]; P < .00001), and headache intensity (mean difference, -1.77 [95% CI, -2.42 to -1.11]; P < .00001) compared with a waiting-list control. Biofeedback demonstrated no adjuvant effect when combined with other behavioral treatment; neither did it have significant advantages over active treatment. Only 40% of bias judgments were deemed as "low" risk. LIMITATIONS: Methodologic issues hampered the meta-analyses. Only a few studies were possible to include, and they suffered from incomplete reporting of data and risk of bias. CONCLUSIONS: Biofeedback seems to be an effective intervention for pediatric migraine, but in light of the limitations, further investigation is needed to increase our confidence in the estimate.