单次经颅磁刺激治疗有先兆偏头痛急性发作的随机、双盲、平行分组、假刺激对照试验。

Single-pulse transcranial magnetic stimulation for acute treatment of migraine with aura: a randomised, double-blind, parallel-group, sham-controlled trial.

机构信息

Department of Neurology, Albert Einstein College of Medicine, Bronx, NY 10461, USA

出版信息

Lancet Neurol. 2010 Apr;9(4):373-80. doi: 10.1016/S1474-4422(10)70054-5. Epub 2010 Mar 4.

DOI:10.1016/S1474-4422(10)70054-5

PMID:20206581

Abstract

BACKGROUND

Preliminary work suggests that single-pulse transcranial magnetic stimulation (sTMS) could be effective as a treatment for migraine. We aimed to assess the efficacy and safety of a new portable sTMS device for acute treatment of migraine with aura.

METHODS

We undertook a randomised, double-blind, parallel-group, two-phase, sham-controlled study at 18 centres in the USA. 267 adults aged 18-68 years were enrolled into phase one. All individuals had to meet international criteria for migraine with aura, with visual aura preceding at least 30% of migraines followed by moderate or severe headache in more than 90% of those attacks. 66 patients dropped out during phase one. In phase two, 201 individuals were randomly allocated by computer to either sham stimulation (n=99) or sTMS (n=102). We instructed participants to treat up to three attacks over 3 months while experiencing aura. The primary outcome was pain-free response 2 h after the first attack, and co-primary outcomes were non-inferiority at 2 h for nausea, photophobia, and phonophobia. Analyses were modified intention to treat and per protocol. This trial is registered with ClinicalTrials.gov, number NCT00449540.

FINDINGS

37 patients did not treat a migraine attack and were excluded from outcome analyses. 164 patients treated at least one attack with sTMS (n=82) or sham stimulation (n=82; modified intention-to-treat analysis set). Pain-free response rates after 2 h were significantly higher with sTMS (32/82 [39%]) than with sham stimulation (18/82 [22%]), for a therapeutic gain of 17% (95% CI 3-31%; p=0.0179). Sustained pain-free response rates significantly favoured sTMS at 24 h and 48 h post-treatment. Non-inferiority was shown for nausea, photophobia, and phonophobia. No device-related serious adverse events were recorded, and incidence and severity of adverse events were similar between sTMS and sham groups.

INTERPRETATION

Early treatment of migraine with aura by sTMS resulted in increased freedom from pain at 2 h compared with sham stimulation, and absence of pain was sustained 24 h and 48 h after treatment. sTMS could be a promising acute treatment for some patients with migraine with aura.

FUNDING

Neuralieve.

摘要

背景

初步研究表明，单次经颅磁刺激（sTMS）可能是治疗偏头痛的有效方法。我们旨在评估一种新的便携式 sTMS 设备治疗有先兆偏头痛的疗效和安全性。

方法

我们在美国的 18 个中心进行了一项随机、双盲、平行组、两阶段、假对照研究。267 名年龄在 18-68 岁的成年人被纳入第一阶段。所有患者均符合偏头痛伴先兆的国际标准，有视觉先兆，偏头痛中有先兆的比例至少为 30%，且 90%以上的偏头痛伴有中度或重度头痛。第一阶段有 66 名患者脱落。在第二阶段，201 名患者通过计算机随机分为假刺激组（n=99）或 sTMS 组（n=102）。我们指导参与者在 3 个月内治疗多达 3 次偏头痛先兆发作。主要结局为首次发作后 2 小时无疼痛反应，次要结局为 2 小时时恶心、畏光和畏声无差异。分析采用意向治疗和方案分析。本试验在 ClinicalTrials.gov 注册，编号为 NCT00449540。

结果

37 名患者未治疗偏头痛发作，被排除在结局分析之外。164 名患者至少治疗了一次偏头痛发作，其中 sTMS 组 82 例（n=82），假刺激组 82 例（n=82；意向治疗分析集）。2 小时后 sTMS 组的无疼痛反应率明显高于假刺激组（32/82[39%]比 18/82[22%]），治疗获益为 17%（95%CI 3-31%；p=0.0179）。治疗后 24 小时和 48 小时 sTMS 组持续无疼痛反应率显著更高。恶心、畏光和畏声无差异。未记录到与设备相关的严重不良事件，sTMS 组和假刺激组的不良事件发生率和严重程度相似。