目的评价单脉冲经颅磁刺激(sTMS)预防性治疗偏头痛的疗效和耐受性。背景sTMS最初用于先兆偏头痛的急性治疗。开放标签的经验表明了预防性益处。该试验的目的是评估sTMS预防偏头痛的疗效和耐受性。方法eNeuraSpringTMS上市后观察美国偏头痛研究(ESPOUSE)研究是一个多中心,prospective,开放标签,观察性研究。从2014年12月至2016年3月,偏头痛患者(n=263)同意完成1个月的基线头痛日记,然后进行3个月的治疗。治疗方案包括预防性(每天两次四次脉冲)和急性(每次发作重复三次脉冲多达三次)治疗。患者每天报告头痛状态,药物使用,和设备使用每月头痛日记。主端点,与基线相比,头痛天数平均减少,在第9到12周的28天期间测量。将主要终点与统计学得出的安慰剂估计值(性能目标)进行比较。次要终点包括:50%的应答率,急性头痛药物消耗,HIT-6和任何强度的总头痛天数从基线的平均减少。结果共有263名同意的受试者,229完成了基线日记,根据头痛天数,发现220人符合资格。该装置被分配给217名受试者(安全数据集),132名受试者被包括在意向治疗全分析集中。对于主端点,与性能目标(-0.63天)相比,头痛天数从基线(9.06天)平均减少-2.75±0.40(p<0.0001).50%的应答率为46%(95%CI37%,56%)也显著高于(p<0.0001)成绩目标(20%)。急性药物使用减少了-2.93(5.24)天,通过HIT-6测量的头痛影响,-3.1(6.4)(p<0.0001),与性能目标(-0.63天)相比,任何强度的总头痛天数-3.16天(5.21)(p<0.0001)。最常见的不良事件是头昏眼花(3.7%),刺痛(3.2%),和耳鸣(3.2%)。无严重不良事件发生。结论这项开放标签研究表明,sTMS可能是一种有效的,偏头痛预防的耐受性良好的治疗选择。试验注册号NCT02357381。
Objective To evaluate the efficacy and tolerability of single pulse transcranial magnetic stimulation (sTMS) for the preventive treatment of migraine. Background sTMS was originally developed for the acute treatment of migraine with aura. Open label experience has suggested a preventive benefit. The objective of this trial was to evaluate the efficacy and tolerability of sTMS for migraine prevention. Methods The eNeura SpringTMS Post-Market Observational U.S. Study of Migraine (ESPOUSE) Study was a multicenter, prospective, open label, observational study. From December 2014 to March 2016, patients with migraine (n = 263) were consented to complete a 1-month baseline headache diary followed by 3 months of treatment. The treatment protocol consisted of preventive (four pulses twice daily) and acute (three pulses repeated up to three times for each attack) treatment. Patients reported daily headache status, medication use, and device use with a monthly headache diary. The primary endpoint, mean reduction of headache days compared to baseline, was measured over the 28-day period during weeks 9 to 12. The primary endpoint was compared to a statistically-derived placebo estimate (performance goal). Secondary endpoints included: 50% responder rate, acute headache medication consumption, HIT-6, and mean reduction in total headache days from baseline of any intensity. Results Of a total of 263 consented subjects, 229 completed a baseline diary, and 220 were found to be eligible based on the number of headache days. The device was assigned to 217 subjects (Safety Data Set) and 132 were included in the intention to treat Full Analysis Set. For the primary endpoint, there was a -2.75 ± 0.40 mean reduction of headache days from baseline (9.06 days) compared to the performance goal (-0.63 days) ( p < 0.0001). The 50% responder rate of 46% (95% CI 37%, 56%) was also significantly higher ( p < 0.0001) than the performance goal (20%). There was a reduction of -2.93 (5.24) days of acute medication use, headache impact measured by HIT-6, -3.1 (6.4) ( p < 0.0001), and total headache days of any intensity -3.16 days (5.21) compared to the performance goal (-0.63 days) ( p < 0.0001). The most common adverse events were lightheadedness (3.7%), tingling (3.2%), and tinnitus (3.2%). There were no serious adverse events. Conclusions This open label study suggests that sTMS may be an effective, well-tolerated treatment option for migraine prevention. Trial registration number NCT02357381.