Abstract
INTRODUCTION: Biofeedback is a non-pharmacological treatment option valued for its minimal risk of adverse events and offers a safe alternative for individuals seeking preventive care for migraine. Despite level A evidence for migraine prevention, biofeedback treatment is still unavailable to most patients. We developed a novel medical device (Cerebri) for multimodal biofeedback treatment that omits the need for healthcare personnel involvement. Cerebri consists of a smartphone application (app) and two wireless sensors. Unique in its approach, the Cerebri app seamlessly integrates three biofeedback modalities - heart rate variability, temperature, and electromyography - making it a comprehensive, therapist-independent solution for non-pharmacological migraine management. METHODS: Biofeedback therapy using Cerebri for the prevention of migraine attacks in adults with episodic migraine (The BioCer study) is an open-label, randomized, waitlist-controlled, multicenter trial. This study investigates the safety and efficacy of daily home-based biofeedback sessions using the Cerebri device. A total of 286 participants will be randomized to either a 12-week intervention arm or waitlist control arm. The primary outcome is the change in the mean number of migraine days from baseline to the last 28-day period during the treatment phase in the treatment group compared with the control group. The primary outcome variable is prospectively collected through daily eDiary entries. A limitation is the inability to conduct a sham-controlled trial of biofeedback. ETHICS AND DISSEMINATION: Approval from the ethics committee and competent authorities was obtained prior to study initiation. Participation is voluntary and informed and written consent is obtained prior to inclusion. The results of this trial will be published in peer-reviewed international medical journals and communicated to patients and healthcare personnel through the relevant channels. TRIAL REGISTRATION NUMBERS: EUDAMED: CIV-NO-22-08-040446REK (Regional Committees for Medical and Health Research Ethics): 502734 Date of approval 2022-10-14Trial registration: NCT05616741, 2022-11-15, https://clinicaltrials.gov/study/NCT05616741.