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Poole AC, Winnberg I, Simpson MR, Stubberud A, Vetvik KG, Bjørk MH, Øie LR, Holmboe P, Olsen A, Tronvik E, Meisingset TW
Feasibility of a 12-Week, Therapist-Independent, Smartphone-Based Biofeedback Treatment for Episodic Migraine in Adults: Single-Center, Open-Label, 1-Armed Trial
A Smartphone-Based Biofeedback Treatment for Episodic Migraine in Adults: A Feasibility Study of a 12-week Therapist-Independent Treatment
Amalie Christine Poole;
Ingunn Winnberg;
Melanie Rae Simpson;
Anker Stubberud;
Kjersti Grøtta Vetvik;
Marte-Helene Bjørk;
Lise Rystad Øie;
Petter Holmboe;
Alexander Olsen;
Erling Tronvik;
Tore Wergeland Meisingset
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
Citation
Please cite as:
Poole AC, Winnberg I, Simpson MR, Stubberud A, Vetvik KG, Bjørk MH, Øie LR, Holmboe P, Olsen A, Tronvik E, Meisingset TW
Feasibility of a 12-Week, Therapist-Independent, Smartphone-Based Biofeedback Treatment for Episodic Migraine in Adults: Single-Center, Open-Label, 1-Armed Trial