Study protocol for a randomized controlled trial of neurofeedback mindfulness in chronic migraines

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Contemporary Clinical Trials Communications Pub Date : 2024-08-28 DOI:10.1016/j.conctc.2024.101362

Faly Golshan , Rachel Lysenko , Monika Nabi Zade , Parham Alibolandi , Haley Block , Paul Masiowski , Megan E. O'Connell , Gloria Sun , Marla Mickleborough

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Abstract

Chronic migraine is a debilitating headache disorder that is associated with excessive analgesic use. As the long-term use of analgesics could cause additional headaches due to medication overuse, there is a need to probe efficient nonprophylactic alternatives and migraineurs’ long-term adherence to such possible treatments. This protocol investigates the integration of neurofeedback and mindfulness which are the two common nonpharmacological therapies for migraines. We offer the use of portable EEG headbands for easy home-based data collection and consistent data access from researchers. In order to evaluate the efficacy of this recommended intervention, this is a protocol for a randomized control trial with a waitlisted group and an intervention group consisting of a daily attention task. The protocol presents important criteria which should be checked for consistency in longitudinal data collection from adults with chronic migraine.

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慢性偏头痛神经反馈正念随机对照试验研究方案

慢性偏头痛是一种使人衰弱的头痛疾病，与过度使用镇痛药有关。由于长期使用镇痛药可能会因用药过度而导致更多头痛，因此有必要研究高效的非预防性替代疗法以及偏头痛患者对这些可能疗法的长期依从性。本方案研究了神经反馈和正念这两种常见的偏头痛非药物疗法的整合。我们提供便携式脑电图头带，方便研究人员在家收集数据并持续访问数据。为了评估这种推荐干预方法的疗效，我们制定了随机对照试验方案，其中包括候补组和干预组，干预组包括每日注意力任务。该方案提出了一些重要标准，在对患有慢性偏头痛的成年人进行纵向数据收集时，应检查这些标准是否一致。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology

CiteScore

2.70

自引率

6.70%

发文量

146

审稿时长

20 weeks

期刊介绍： Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.