远程电神经调节用于青少年偏头痛的急性治疗

Remote electrical neuromodulation for acute treatment of migraine in adolescents.

作者信息

Hershey Andrew D, Lin Tamar, Gruper Yaron, Harris Dagan, Ironi Alon, Berk Thomas, Szperka Christina L, Berenson Frank

机构信息

Division of Neurology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.

Department of Pediatrics, University of Cincinnati, College of Medicine Cincinnati, Cincinnati, OH, USA.

出版信息

Headache. 2021 Feb;61(2):310-317. doi: 10.1111/head.14042. Epub 2020 Dec 21.

DOI:10.1111/head.14042

PMID:33349920

Abstract

OBJECTIVES

Migraine is a common disabling neurological disorder. Current acute treatments for migraine in adolescents are mostly pharmacological and may have limited effectiveness, can cause side effects, and may lead to medication overuse. There is an unmet need for effective and well-tolerated treatments. Remote electrical neuromodulation (REN) is a novel acute treatment of migraine that stimulates upper arm peripheral nerves to induce conditioned pain modulation (CPM)-an endogenous analgesic mechanism. The REN device (Nerivio , Theranica Bio-Electronics Ltd., Israel) is a FDA-authorized device for acute treatment of migraine in adults. This study assessed the efficacy and safety of REN in adolescents with migraine.

DESIGN AND METHODS

This was an open-label, single-arm, multicenter study in adolescents (ages 12-17 years) with migraine. Participants underwent a 4-week run-in phase. Eligible participants continued to an 8-week treatment phase with the device. Pain severity, associated symptoms, and functional disability were recorded at treatment initiation, and 2 and 24 hours post-treatment. The primary endpoints of this study were related to the safety and tolerability of REN. The secondary endpoints were related to device efficacy and included the proportion of participants who achieved pain relief at 2 hours post-treatment and the proportion of participants who achieved pain freedom at 2 hours. The presented results reflect an interim analysis with subsequent stopping of the rest of the study.

RESULTS

Sixty participants were enrolled for the study; of these, 14 failed to meet the run-in criteria and 1 was lost to follow-up. Forty-five participants performed at least one treatment, of which 39 participants completed a test treatment with REN. One device-related adverse event (2%) was reported in which a temporary feeling of pain in the arm was felt. Pain relief and pain-free at 2 hours were achieved by 71% (28/39) and 35% (14/39) participants, respectively. At 2 hours, 69% (23/33) participants experienced improvement in functional ability.

CONCLUSIONS

REN may offer a safe and effective non-pharmacological alternative for acute treatment in adolescents.

摘要

目的

偏头痛是一种常见的致残性神经系统疾病。目前青少年偏头痛的急性治疗大多是药物治疗，可能效果有限，会引起副作用，还可能导致药物过度使用。对于有效且耐受性良好的治疗方法存在未满足的需求。远程电神经调节（REN）是一种新型的偏头痛急性治疗方法，它刺激上臂周围神经以诱导条件性疼痛调制（CPM）——一种内源性镇痛机制。REN设备（Nerivio ，Theranica生物电子有限公司，以色列）是一种获得美国食品药品监督管理局（FDA）授权用于成人偏头痛急性治疗的设备。本研究评估了REN在青少年偏头痛患者中的疗效和安全性。

设计与方法

这是一项针对青少年（12至17岁）偏头痛患者的开放标签、单臂、多中心研究。参与者经历了为期4周的导入期。符合条件的参与者继续使用该设备进行为期8周的治疗期。在治疗开始时以及治疗后2小时和24小时记录疼痛严重程度、相关症状和功能障碍。本研究的主要终点与REN的安全性和耐受性有关。次要终点与设备疗效有关，包括治疗后2小时实现疼痛缓解的参与者比例以及治疗后2小时实现疼痛消失的参与者比例。呈现的结果反映了一项中期分析，随后停止了研究的其余部分。

结果

60名参与者被纳入研究；其中，14名未达到导入期标准，1名失访。45名参与者至少进行了一次治疗，其中39名参与者完成了REN的测试治疗。报告了1例与设备相关的不良事件（2%），即感觉手臂有短暂疼痛感。分别有71%（28/39）和35%（14/39）的参与者在治疗后2小时实现了疼痛缓解和疼痛消失。在治疗后2小时，69%（23/33）的参与者功能能力得到改善。