Feasibility of a 12-Week, Therapist-Independent, Smartphone-Based Biofeedback Treatment for Episodic Migraine in Adults: Single-Center, Open-Label, 1-Armed Trial

TL;DR

A new smartphone-based biofeedback device for migraine treatment showed high initial engagement but declining use over time due to technical issues.

Contribution

The study introduces a therapist-independent biofeedback device for migraine prevention and evaluates its feasibility and usability.

Findings

Initial adherence to the biofeedback system was high but dropped significantly by weeks 9-12.

eDiary adherence remained consistently high throughout the 12-week trial.

No safety concerns were reported, but software issues affected app usability.

Abstract

Biofeedback is an established treatment principle for migraine, but home-based therapy with proven efficacy is not available.

This study aims to assess the feasibility, usability, and safety of 12 weeks of daily use of a novel medical device (Cerebri; Nordic Brain Tech AS) for therapist-independent multimodal biofeedback preventative treatment in adults with episodic migraine.

In this open-label, one-armed trial, 20 adult participants with episodic migraine used Cerebri 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.

Initial adherence to biofeedback was high (16/20, 80% in weeks 1‐4), declining to 20% (4/20) by weeks 9‐12. eDiary adherence remained high (15/20, 75% in weeks 9‐12). Reduction in migraine days was not significant (–0.6, 95% CI –2.4 to 1.1 days; P=.47). App usability was impacted by software issues. No safety concerns were reported.

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.

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