Headache Science & Neurorehabilitation Centre, IRCCS C. Mondino Foundation, Pavia, Italy.
Department of Brain and Behavioral Sciences, University of Pavia, Italy.
Cephalalgia. 2021 Oct;41(11-12):1135-1151. doi: 10.1177/03331024211010413. Epub 2021 May 14.
Although the European Medicines Agency and the US Food and Drug Administration have cleared several devices that use neuromodulation to provide clinical benefits in the acute or preventive treatment of migraine, the Clinical Trials Committee of the International Headache Society has not developed guidelines specifically for clinical trials of neuromodulation devices. In recognition of the distinct needs and challenges associated with their assessment in controlled trials, the Committee provides these recommendations for optimizing the design and conduct of controlled trials of neuromodulation devices for the acute and/or preventive treatment of migraine.
An international group of headache scientists and clinicians with expertise in neuromodulation evaluated clinical trials involving neuromodulation devices that have been published since 2000. The Clinical Trials Committee incorporated findings from this expert analysis into a new guideline for clinical trials of neuromodulation devices for the treatment of migraine.
Key terms were defined and recommendations provided relative to the assessment of neuromodulation devices for acute treatment in adults, preventive treatment in adults, and acute and preventive treatment in children and adolescents. Ethical and administrative responsibilities were outlined, and a bibliography of previous research involving neuromodulation devices was created.
Adoption of these recommendations will improve the quality of evidence regarding this important area in migraine treatment.
尽管欧洲药品管理局和美国食品药品监督管理局已经批准了几种使用神经调节来提供偏头痛急性或预防性治疗临床获益的设备，但国际头痛协会临床研究委员会尚未制定专门针对神经调节设备临床试验的指南。为了认识到在对照试验中评估这些设备的独特需求和挑战，委员会为优化神经调节设备用于偏头痛急性和/或预防性治疗的对照试验设计和实施提供了这些建议。
一个由具有神经调节专业知识的头痛科学家和临床医生组成的国际小组评估了自 2000 年以来发表的涉及神经调节设备的临床试验。临床研究委员会将从这项专家分析中得出的结果纳入了用于偏头痛治疗的神经调节设备临床试验的新指南。
针对成人急性治疗、成人预防性治疗以及儿童和青少年急性和预防性治疗，定义了关键术语并提供了建议。概述了伦理和行政责任，并创建了涉及神经调节设备的先前研究的参考书目。
采用这些建议将提高偏头痛治疗这一重要领域证据的质量。
