Poole Amalie Christine, Winnberg Ingunn Grøntveit, Simpson Melanie Rae, Stubberud Anker, Vetvik Kjersti Grøtta, Bjørk Marte-Helene, Øie Lise Rystad, Holmboe Petter, Olsen Alexander, Tronvik Erling, Wergeland Tore
Norwegian Centre for Headache Research (NorHead), NTNU Norwegian University of Science and Technology, Trondheim, Norway.
Department of Neurology and Neurophysiology, St. Olavs University Hospital, Trondheim, Norway, 47 73 59 20 20.
JMIR Hum Factors. 2025 Jun 9;12:e59622. doi: 10.2196/59622.
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.
生物反馈是一种已确立的偏头痛治疗原则，但尚无经证实有效的家庭治疗方法。
本研究旨在评估一种新型医疗设备（Cerebri；北欧脑科技公司）在发作性偏头痛成人患者中进行为期12周的每日使用，用于独立于治疗师的多模式生物反馈预防性治疗的可行性、可用性和安全性。
在这项开放标签、单臂试验中，20名发作性偏头痛成年参与者使用Cerebri达12周。主要结局是Cerebri系统的可行性，通过每日生物反馈和电子头痛日记（eDiary）记录的依从水平来衡量。次要结局是安全性、可用性和疗效。
最初对生物反馈的依从性较高（第1 - 4周为16/20，80%），到第9 - 12周降至20%（4/20）。eDiary的依从性保持较高（第9 - 12周为15/20，75%）。偏头痛天数的减少不显著（-0.6，95%可信区间-2.4至1.1天；P = 0.47）。应用程序的可用性受到软件问题的影响。未报告安全问题。
Cerebri在自我管理的偏头痛治疗中显示出潜力，初始参与度高且安全性良好。可用性问题，包括技术故障，被确定为依从性下降的最重要可改变原因。这突出了进一步改进应用程序以维持用户参与度的必要性。
