Accepted for/Published in: JMIR Human Factors
Date Submitted: Apr 19, 2024
Date Accepted: Mar 4, 2025
A Smartphone-Based Biofeedback Treatment for Episodic Migraine in Adults: A Feasibility Study of a 12-week Therapist-Independent Treatment
ABSTRACT
Background:
Bioiofeedback is an established treatment principle for migraine, but home-based therapy with proven efficacy is not available.
Objective:
To evaluate the feasibility, usability, and safety of the Cerebri system, a novel medical device for therapist-independent multimodal biofeedback treatment.
Methods:
In this open-label, one-armed trial, 20 adult participants with episodic migraine used the Cerebri smartphone application (app) and sensors for 12 weeks. The primary outcome was the feasibility of the Cerebri system, measured by the level of adherence to daily biofeedback and electronic headache diary (eDiary) entries. Secondary outcomes were safety, usability and efficacy.
Results:
Initial adherence to biofeedback was high (80% in weeks 1-4), declining to 20% by weeks 9-12. eDiary adherence remained high (75% in weeks 9-12). Reduction in migraine days was not significant (-0.6 days; 95% CI -2.4 to 1.1; p=0.467). App usability was impacted by software issues. No safety concerns were reported.
Conclusions:
Cerebri demonstrates potential in self-managed migraine treatment, with strong initial engagement and high safety. Usability issues including technical bugs were identified as the most important modifiable cause for the decline in adherence. This highlights the need for further app refinement to sustain user engagement. Clinical Trial: NCT05454319
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