Hong Yaejee H, Wu Steve W, Pedapati Ernest V, Horn Paul S, Huddleston David A, Laue Cameron S, Gilbert Donald L
College of Medicine, University of Cincinnati Cincinnati, OH, USA.
Division of Neurology, Cincinnati Children's Hospital Medical Center Cincinnati, OH, USA.
Front Hum Neurosci. 2015 Feb 4;9:29. doi: 10.3389/fnhum.2015.00029. eCollection 2015.
Although single- and paired-pulse (sp/pp) transcranial magnetic stimulation (TMS) studies are considered minimal risk in adults and children, the safety profile for theta-burst TMS (TBS) is unknown.
In this comparative analysis, we explored the rate, severity, and specific symptoms of TMS-related adverse effects (AEs) between sp/ppTMS and TBS in subjects between ages 6 and 18 years.
Data from 165 participants from 2009 to 2014 were analyzed. Assessment of AEs was performed based on baseline and post-TMS administration of a symptom-based questionnaire that rated AEs on a 5-level ordinal scale (minimal, mild, moderate, marked, severe). AE rates and severity were compared using Chi Square or Fisher's Exact Test depending on data characteristics.
Overall, no seizures or severe-rated AEs were reported by 165 pediatric participants. The rate of AE in all TBS sessions was 10.5% (n = 76, 95% CI: 4.7-19.7%), whereas the rate of AE in all sp/ppTMS sessions was 12.4% (n = 89, 95% CI: 6.3-21.0%). There was no statistical difference in AE rates between TBS and sp/ppTMS (p = 0.71). In all sp/ppTMS and TBS sessions, 20 subjects reported a total of 35 AEs, among these 31 (~88.6%) were rated as "minimal" or "mild". There was no difference in the severity of AE between TBS and sp/ppTMS (p = 1.0). Only one of 76 TBS participants reported an AE rated as more than minimal/mild.
Our comparative analysis showed that TBS appears to be as safe as sp/ppTMS in terms of AE rate and severity. This report supports further investigation of TBS in children.
尽管单脉冲和双脉冲（sp/pp）经颅磁刺激（TMS）研究在成人和儿童中被认为风险极小，但theta爆发式TMS（TBS）的安全性尚不明确。
在这项对比分析中，我们探讨了6至18岁受试者中，sp/ppTMS与TBS之间TMS相关不良反应（AE）的发生率、严重程度及具体症状。
分析了2009年至2014年165名参与者的数据。基于症状的问卷在TMS治疗前和治疗后进行AE评估，该问卷将AE按5级序贯量表（极小、轻度、中度、显著、严重）进行评分。根据数据特征，使用卡方检验或费舍尔精确检验比较AE发生率和严重程度。
总体而言，165名儿科参与者均未报告癫痫发作或严重程度的AE。所有TBS治疗的AE发生率为10.5%（n = 76，95%CI：4.7 - 19.7%），而所有sp/ppTMS治疗的AE发生率为12.4%（n = 89，95%CI：6.3 - 21.0%）。TBS与sp/ppTMS之间的AE发生率无统计学差异（p = 0.71）。在所有sp/ppTMS和TBS治疗中，20名受试者共报告了35例AE，其中31例（约88.6%）被评为“极小”或“轻度”。TBS与sp/ppTMS之间的AE严重程度无差异（p = 1.0）。76名TBS参与者中只有1人报告了1例AE，其严重程度超过极小/轻度。
我们的对比分析表明，在AE发生率和严重程度方面，TBS似乎与sp/ppTMS一样安全。本报告支持对儿童TBS进行进一步研究。
