Biofeedback training can reduce affected days in episodic migraine

In a randomised trial, biofeedback intervention using a smartphone app and sensor system improved the mean number of migraine days with minimal safety impact in adult patients with episodic migraine.

Dr Amalie Christine Poole (Norwegian University of Science and Technology, Norway) and colleagues designed the open-label, multicentre, randomised BioCer trial (NCT05616741), which compared the efficacy and safety of the therapist-independent biofeedback smartphone app and sensor system ‘Cerebri’ with a waitlist control group [1]. In the trial, 279 adults with episodic migraine were assigned 1:1 to 12-week biofeedback training with Cerebri (10-minute interventions) or to the control group. The trial’s primary endpoint was the mean number of monthly migraine days change from baseline to the end of the last 28-day treatment cycle.

The mean monthly migraine days at baseline were 4.8 days in the Cerebri group and 4.6 days in the waitlist group. At the end of the trial, the mean monthly migraine days decreased by 0.9 days in the Cerebri group but stayed exactly the same in the waitlist control group, corresponding to a between-group difference of -0.9 (95% CI -1.5 to -0.3, P=0.002). Furthermore, the Cerebri intervention versus control also led to significant improvement in migraine intensity and a significantly higher proportion of participants with ≥30% reduction in mean monthly number of migraine days (44.3% vs 29.9%; OR 1.86; 95% CI 1.05–3.30; P=0.033). Participants reported 139 treatment-emergent adverse events, with the majority unrelated to the intervention. Two adverse events were assessed as casually related and included pruritus and light-headedness. Two serious adverse events were reported, but these were deemed unrelated (appendicitis and severe menorrhagia).

The authors concluded that “biofeedback treatment with Cerebri is a safe and effective preventative treatment for episodic migraine in adults.”

1. Poole AC, et al. Home-based biofeedback therapy for migraine prevention in adults with episodic migraine using a novel therapist-independent smartphone system: a randomized, waitlist-controlled trial. 18^th European Headache Congress, 4–7 December 2024, Rotterdam, the Netherlands.

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Posted on 6 January 2025