Background

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.

Methods

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.

Results

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.

Conclusions

Adoption of these recommendations will improve the quality of evidence regarding this important area in migraine treatment.

中文翻译：

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国际头痛学会使用神经调节装置治疗偏头痛的临床试验指南

背景

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在偏头痛的急性或预防性治疗中提供临床益处的设备，但国际头痛协会的临床试验委员会尚未制定专门用于临床试验的指南。神经调节装置。鉴于与对照试验评估相关的独特需求和挑战，委员会提供了这些建议，以优化用于偏头痛急性和/或预防性治疗的神经调节装置对照试验的设计和实施。

方法

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装置的临床试验。临床试验委员会将这一专家分析的结果纳入了用于治疗偏头痛的神经调节装置临床试验的新指南.

结果

对用于成人急性治疗、成人预防性治疗以及儿童和青少年急性和预防性治疗的神经调节装置的评估定义了关键术语并提供了建议。概述了道德和行政责任，并创建了先前涉及神经调节装置的研究的参考书目。

结论

采纳这些建议将提高偏头痛治疗这一重要领域的证据质量。