Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research.

Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research.
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DOI:
10.1016/j.clinph.2009.08.016
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发表时间:
2009-12
期刊:
Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology
影响因子:
--
通讯作者:
Safety of TMS Consensus Group
Safety of TMS Consensus Group
中科院分区:
其他
文献类型:
--
作者:
Rossi S;Hallett M;Rossini PM;Pascual-Leone A;Safety of TMS Consensus Group

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本文基于2008年3月7日至9日在锡耶纳(意大利)Certosa di Pontignano举行的共识会议,旨在更新先前经颅磁刺激(TMS)在研究和临床环境中应用的安全指南。在过去的十年中,科学和医学界有机会评估TMS和重复TMS(rTMS)的研究和临床应用的安全记录。在这些年中,常规TMS的应用数量已经令人印象深刻地增长,已经开发了新的刺激范例(例如,模式化重复TMS)和技术进步导致了新的设备设计以及TMS与脑电图(EEG)、正电子发射断层扫描(PET)和功能性磁共振成像(fMRI)的实时集成。数千名健康受试者和患有各种神经和精神疾病的患者接受了TMS,从而可以更好地评估相对风险。癫痫发作的发生(即,最严重的经颅磁刺激相关急性不良反应)极为罕见,接受rTMS治疗的少数新病例中的大多数都超过了先前的指南,通常是在接受可能降低癫痫发作阈值的药物治疗的患者中。本更新指南审查了传统TMS方案的风险和安全性问题,解决了新兴TMS干预的不良影响和风险,TMS在中枢神经系统植入电极的患者中的应用,以及TMS在神经成像环境中的安全性问题。我们涵盖了刺激参数和其他重要预防措施的建议限制,受试者的监测,rTMS团队的专业知识和伦理问题。虽然这里的所有建议都是基于专家的,但它们尽可能地利用了已公布的数据。
This article is based on a consensus conference, which took place in Certosa di Pontignano, Siena (Italy) on March 7–9, 2008, intended to update the previous safety guidelines for the application of transcranial magnetic stimulation (TMS) in research and clinical settings. Over the past decade the scientific and medical community has had the opportunity to evaluate the safety record of research studies and clinical applications of TMS and repetitive TMS (rTMS). In these years the number of applications of conventional TMS has grown impressively, new paradigms of stimulation have been developed (e.g., patterned repetitive TMS) and technical advances have led to new device designs and to the real-time integration of TMS with electroencephalography (EEG), positron emission tomography (PET) and functional magnetic resonance imaging (fMRI). Thousands of healthy subjects and patients with various neurological and psychiatric diseases have undergone TMS allowing a better assessment of relative risks. The occurrence of seizures (i.e., the most serious TMS-related acute adverse effect) has been extremely rare, with most of the few new cases receiving rTMS exceeding previous guidelines, often in patients under treatment with drugs which potentially lower the seizure threshold. The present updated guidelines review issues of risk and safety of conventional TMS protocols, address the undesired effects and risks of emerging TMS interventions, the applications of TMS in patients with implanted electrodes in the central nervous system, and safety aspects of TMS in neuroimaging environments. We cover recommended limits of stimulation parameters and other important precautions, monitoring of subjects, expertise of the rTMS team, and ethical issues. While all the recommendations here are expert based, they utilize published data to the extent possible.
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