Biofeedback therapy using Cerebri for the prevention of migraine attacks in adults with episodic migraine (BioCer): a randomized, wait-list controlled trial – the study protocol

Q2 Pharmacology, Toxicology and Pharmaceutics

F1000Research Pub Date : 2024-07-08 DOI:10.12688/f1000research.149807.1

Amalie Christine Poole, Anker Stubberud, Melanie Simpson, Lise R. Øie, Einar Tobias Vassbø Skalstad, M. Bjørk, E. Kristoffersen, K. Vetvik, A. Olsen, Iben Cornelia Keim Larsen, Mattias Linde, E. Tronvik, T. W. Meisingset

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引用次数: 0

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) was an open-label, randomized, waitlist-controlled, multicenter trial. This study investigated 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 was 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 was prospectively collected through daily eDiary entries. Ethics and Dissemination Approval from the ethics committee and competent authorities was obtained prior to study initiation. Participation was voluntary and informed and written consent was 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-22-08-040446 REK (Regional Committees for Medical and Health Research Ethics): 502734 Date of approval 2022-10-14 Trial registration: NCT05616741, 2022-11-15, https://clinicaltrials.gov/study/NCT05616741

查看原文本刊更多论文

使用 Cerebri 生物反馈疗法预防发作性偏头痛成人患者的偏头痛发作（BioCer）：随机、等待名单对照试验--研究方案

导言生物反馈疗法是一种非药物治疗方法，因其不良反应风险极低而备受推崇，为寻求偏头痛预防治疗的患者提供了一种安全的选择。尽管生物反馈疗法对偏头痛的预防效果达到了A级，但大多数患者仍无法接受这种疗法。我们开发了一种新型医疗设备（Cerebri），用于多模式生物反馈治疗，无需医护人员参与。Cerebri 由一个智能手机应用程序和两个无线传感器组成。Cerebri 应用程序采用独特的方法，无缝整合了三种生物反馈模式--心率变异性、体温和肌电图--使其成为非药物治疗偏头痛的全面、独立于治疗师的解决方案。方法使用 Cerebri 生物反馈疗法预防发作性偏头痛成人患者的偏头痛发作（BioCer 研究）是一项开放标签、随机、候选对照、多中心试验。该研究调查了使用 Cerebri 设备进行每日家庭生物反馈疗程的安全性和有效性。共有 286 名参与者将被随机分配到为期 12 周的干预组或候补对照组。主要结果是治疗组与对照组相比，偏头痛天数从基线到治疗阶段最后28天的平均变化。主要结果变量通过每日电子日记条目进行前瞻性收集。伦理与传播研究启动前已获得伦理委员会和主管部门的批准。参与者自愿参与，并在纳入研究前获得知情和书面同意。试验结果将在同行评审的国际医学期刊上发表，并通过相关渠道告知患者和医护人员。试验注册号：EUDAMED：CIV-NO-22-08-040446 REK（医疗与健康研究伦理地区委员会）：502734 批准日期 2022-10-14 试验注册：NCT05616741, 2022-11-15, https://clinicaltrials.gov/study/NCT05616741

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来源期刊

F1000Research Pharmacology, Toxicology and Pharmaceutics-Pharmacology, Toxicology and Pharmaceutics (all)

CiteScore

5.00

自引率

0.00%

发文量

1646

审稿时长

1 weeks

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