远程电神经调节用于慢性偏头痛患者偏头痛急性治疗的开放标签试点研究
Remote Electrical Neuromodulation for the Acute Treatment of Migraine in Patients with Chronic Migraine: An Open-Label Pilot Study.
作者信息
Nierenburg Hida, Vieira Julio R, Lev Nirit, Lin Tamar, Harris Dagan, Vizel Maya, Ironi Alon, Lewis Bryan, Wright Paul
机构信息
Division of Neurology, Nuvance Health, Poughkeepsie, NY, USA.
Albert Einstein College of Medicine, The Saul R. Korey Department of Neurology, Bronx, NY, USA.
出版信息
Pain Ther. 2020 Dec;9(2):531-543. doi: 10.1007/s40122-020-00185-1. Epub 2020 Jul 9.
INTRODUCTION
Remote electrical neuromodulation (REN) is a novel acute treatment of migraine. Upper arm peripheral nerves are stimulated to induce conditioned pain modulation (CPM)-an endogenous analgesic mechanism in which conditioning stimulation inhibits pain in remote body regions. The REN device (Nerivio, Theranica Bio-Electronics LTD., Israel) is FDA-authorized for acute treatment of migraine in adults who do not have chronic migraine. The current study assessed the consistency of response over multiple migraine attacks in people with chronic migraine who are typically characterized with severe pain intensity, high disability, and less robust response to triptans.
METHODS
This was an open-label, single-arm, dual-center study conducted on adults with chronic migraine. Participants underwent a 4-week treatment phase in which they treated their migraine headaches with the device for 45 min within 1 h of attack onset. Pain levels were recorded at baseline, 2 h, and 24 h post-treatment. Efficacy outcomes (pain relief and pain-free responses at 2 h, sustained pain relief and sustained pain-free responses at 24 h) focused on intra-individual consistency of response across multiple attacks, which was defined as response in at least 50% of the treatments.
RESULTS
Forty-two participants were enrolled, and 38 participants were evaluable for analyses; 73.7% (28/38) achieved pain relief at 2 h, 26.3% (10/38) were pain-free at 2 h, 84.4% (27/32) had sustained pain relief response at 24 h and 45.0% (9/20) had sustained pain relief response at 24 h in at least 50% of their treated attacks. The effects of REN on associated symptoms and improvement in function were also consistent. The incidence of device-related adverse events was low (1.8%).
CONCLUSIONS
REN used for a series of migraine attacks was effective and well tolerated across attacks. REN may offer a safe and effective non-pharmacological alternative for acute treatment in patients with chronic migraine.
TRIAL REGISTRATION
ClinicalTrials.gov identifier, NCT04161807. Retrospectively registered on November 13, 2019.
引言
远程电神经调节（REN）是一种新型的偏头痛急性治疗方法。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，其中条件刺激可抑制身体其他部位的疼痛。REN设备（Nerivio，Theranica Bio-Electronics LTD.，以色列）已获得美国食品药品监督管理局（FDA）授权，用于治疗无慢性偏头痛的成人偏头痛急性发作。本研究评估了慢性偏头痛患者在多次偏头痛发作中的反应一致性，这些患者通常具有严重的疼痛强度、高残疾率以及对曲坦类药物反应较弱的特点。
方法
这是一项针对慢性偏头痛成人患者的开放标签、单臂、双中心研究。参与者经历了为期4周的治疗阶段，在此期间，他们在偏头痛发作开始后1小时内使用该设备治疗45分钟。在基线、治疗后2小时和24小时记录疼痛水平。疗效指标（2小时时的疼痛缓解和无痛反应、24小时时的持续疼痛缓解和持续无痛反应）侧重于多次发作中个体内部反应的一致性，定义为至少50%的治疗中有反应。
结果
共招募了42名参与者，其中38名参与者可纳入分析；73.7%（(28/38)）在2小时时实现了疼痛缓解，26.3%（(10/38)）在2小时时无痛，84.4%（(27/32)）在24小时时有持续疼痛缓解反应，45.0%（(9/20)）在至少50%的治疗发作中在24小时时有持续疼痛缓解反应。REN对相关症状的影响和功能改善也具有一致性。与设备相关的不良事件发生率较低（1.8%）。
结论
用于一系列偏头痛发作的REN在各次发作中均有效且耐受性良好。REN可能为慢性偏头痛患者的急性治疗提供一种安全有效的非药物替代方案。
试验注册
ClinicalTrials.gov标识符，NCT04161807。于2019年11月13日进行回顾性注册。
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