Department of Neurology, University of California, San Francisco (UCSF), San Francisco, CA, USA.
Department of Pediatrics, University of California, San Francisco (UCSF), San Francisco, CA, USA.
Headache. 2018 May;58(5):724-731. doi: 10.1111/head.13284. Epub 2018 Mar 12.
To assess the feasibility, tolerability, and patient acceptability of single-pulse transcranial magnetic stimulation (sTMS) for migraine prevention in adolescents in an open-label pilot study.
Migraine is common in adolescents and can be disabling. Well tolerated preventative therapies that are safe and effective are needed.
This was an open-label prospective pilot feasibility study of sTMS for migraine prevention in adolescents aged 12-17 years. Participants used sTMS twice daily in a preventative fashion, as well as additional pulses as needed acutely. A 4-week baseline run-in period (weeks 1-4) was followed by a 12-week treatment period. Feasibility was the primary outcome. Secondary outcomes included tolerability and acceptability, as well as the change in headache days, number of moderate/severe headache days, days of acute medication use, and PedMIDAS (headache disability) scores between the run-in period (weeks 1-4) and the third month of treatment (weeks 13-16).
Twenty-one participants enrolled. Nineteen completed the baseline run-in, and 12 completed the study. Using sTMS proved feasible and acceptable with overall high compliance once treatment administration was streamlined. Initially, for preventive treatment, participants were asked to give 2 pulses, wait 15 minutes, then give 2 additional pulses twice daily. This 15-minute delay proved challenging for adolescents, particularly on school days, and therefore was dropped. Study completion rate went from 4/13 (31%) to 7/8 (88%) once this change was made, P = .024. On average, participants used the device preventively between 22 and 24 days over a 28-day block. There were no serious adverse events. Two participants reported mild discomfort with device use.
sTMS appears to be a feasible, well-tolerated, and acceptable nonpharmacologic preventive treatment for migraine in adolescents. In designing future trials of sTMS for migraine prevention in adolescents, streamlined treatment administration will be essential to minimize drop-out. Efficacy needs to be assessed in a larger trial.
在一项开放性先导研究中评估单脉冲经颅磁刺激（sTMS）用于预防青少年偏头痛的可行性、耐受性和患者可接受性。
偏头痛在青少年中很常见，且可能致残。需要安全且有效的耐受性良好的预防疗法。
这是一项开放性前瞻性先导研究，评估 sTMS 用于预防 12-17 岁青少年偏头痛。参与者以预防方式每日使用 sTMS 两次，以及根据需要急性使用额外脉冲。为期 4 周的基线导入期（第 1-4 周）后，进行为期 12 周的治疗期。可行性是主要结果。次要结果包括耐受性和可接受性，以及头痛天数、中重度头痛天数、急性用药天数以及头痛残疾程度（PedMIDAS）评分在导入期（第 1-4 周）和治疗的第三个月（第 13-16 周）之间的变化。
21 名参与者入组。19 名完成基线导入期，12 名完成研究。使用 sTMS 证明是可行且可接受的，一旦治疗管理流程化，总体依从性很高。最初，对于预防治疗，参与者被要求给予 2 个脉冲，等待 15 分钟，然后每天给予 2 个额外脉冲。这 15 分钟的延迟对青少年来说具有挑战性，尤其是在上学日，因此被取消。一旦做出这一改变，研究完成率从 4/13（31%）上升到 7/8（88%），P=0.024。平均而言，参与者在 28 天的治疗期内平均使用该设备预防 22-24 天。无严重不良事件。两名参与者报告使用设备时有轻度不适。
sTMS 似乎是一种可行、耐受性良好且可接受的非药物预防偏头痛的治疗方法，适用于青少年。在设计未来青少年偏头痛预防的 sTMS 试验中，简化治疗管理对于最大限度减少脱落至关重要。需要在更大的试验中评估疗效。
