Should transcranial magnetic stimulation research in children be considered minimal risk?
Should transcranial magnetic stimulation research in children be considered minimal risk?
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DOI：
10.1016/j.clinph.2003.10.037
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发表时间：
2004-08-01
影响因子：
4.7
通讯作者：
Wassermann, EM
中科院分区：
文献类型：
--
作者：
Gilbert, DL;Garvey, MA;Wassermann, EM
目的：经颅磁刺激（TMS）是一种具有研究应用价值的神经生理学技术。机构审查委员会（irb）必须仔细考虑涉及儿童的研究的潜在风险和可能的益处。本研究的目的是为研究者和研究机构提供关于儿童单脉冲和配对脉冲经颅磁刺激研究安全性的简明信息。方法：本文共分为4个部分：(1)对儿童研究的相关法规进行综述，并将其应用于经颅磁刺激的研究。（二）根据经颅磁刺激对人体的理论生物学风险来评估经颅磁刺激所传递的能量。（三）通过MEDLINE综述，评估经颅磁刺激风险的经验证据。报告的不良事件，包括与癫痫发作和听力损失风险相关的问题，进行了总结。（IV）安全性数据来自TMS治疗图雷特综合征儿童的研究。结果：没有发表或经验证据表明单脉冲或配对脉冲经颅磁刺激与儿童的风险相关。结论：IRBs可能会考虑设计良好的研究，使用与本研究中描述的类似的单脉冲和成对脉冲TMS方案，对儿童的风险最小。意义：本文可作为IRBs和TMS研究者的参考。(C) 2004年国际临床神经生理学联合会。爱思唯尔爱尔兰有限公司出版。版权所有。
Objective: Transcranial magnetic stimulation (TMS) is a neurophysiologic technique with research applications. Institutional Review Boards (IRBs) must carefully consider potential risks and possible benefits in research involving children. The purpose of this study is to provide concise information for investigators and IRBs about the safety of single and paired pulse TMS research in children.Methods: This paper has 4 sections: (I) Regulations governing research in children are reviewed and applied to the use of TMS. (II) Energy imparted by TMS is assessed in terms of theoretical biological risks to human subjects. (III) Through MEDLINE review, the empirical evidence of risk from TMS is assessed. Reported adverse events, including issues related to risk of seizures and of hearing loss, are summarized. (IV) Safety data are presented from a study of TMS in children with Tourette Syndrome.Results: No published or empirical evidence was found to suggest that single or paired pulse TMS is associated with more than minimal risk in children.Conclusions: IRBs may consider well-designed studies using single and paired pulse TMS protocols similar to those described in this study as bearing minimal risk to children.Significance: This manuscript may be useful as a reference to IRBs and TMS investigators. (C) 2004 International Federation of Clinical Neurophysiology. Published by Elsevier Ireland Ltd. All rights reserved.