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经颅磁刺激和直流电刺激在儿童中的安全性和耐受性:来自 350 万次刺激的前瞻性单中心证据。

Safety and tolerability of transcranial magnetic and direct current stimulation in children: Prospective single center evidence from 3.5 million stimulations.

机构信息

Calgary Pediatric Stroke Program, University of Calgary, Calgary, Alberta, Canada; Departments of Pediatrics and Clinical Neurosciences, University of Calgary, Calgary, Alberta, Canada; Alberta Children's Hospital Research Institute, University of Calgary, Calgary, Alberta, Canada; Department of Neurosciences, University of Calgary, Calgary, Alberta, Canada; Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.

Calgary Pediatric Stroke Program, University of Calgary, Calgary, Alberta, Canada; Department of Neurosciences, University of Calgary, Calgary, Alberta, Canada; Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.

出版信息

Brain Stimul. 2020 May-Jun;13(3):565-575. doi: 10.1016/j.brs.2019.12.025. Epub 2019 Dec 30.

DOI:10.1016/j.brs.2019.12.025
PMID:
32289678
Abstract

BACKGROUND

Non-invasive brain stimulation is being increasingly used to interrogate neurophysiology and modulate brain function. Despite the high scientific and therapeutic potential of non-invasive brain stimulation, experience in the developing brain has been limited.

OBJECTIVE

To determine the safety and tolerability of non-invasive neurostimulation in children across diverse modalities of stimulation and pediatric populations.

METHODS

A non-invasive brain stimulation program was established in 2008 at our pediatric, academic institution. Multi-disciplinary neurophysiological studies included single- and paired-pulse Transcranial Magnetic Stimulation (TMS) methods. Motor mapping employed robotic TMS. Interventional trials included repetitive TMS (rTMS) and transcranial direct current stimulation (tDCS). Standardized safety and tolerability measures were completed prospectively by all participants.

RESULTS

Over 10 years, 384 children underwent brain stimulation (median 13 years, range 0.8-18.0). Populations included typical development (n = 118), perinatal stroke/cerebral palsy (n = 101), mild traumatic brain injury (n = 121) neuropsychiatric disorders (n = 37), and other (n = 7). No serious adverse events occurred. Drop-outs were rare (<1%). No seizures were reported despite >100 participants having brain injuries and/or epilepsy. Tolerability between single and paired-pulse TMS (542340 stimulations) and rTMS (3.0 million stimulations) was comparable and favourable. TMS-related headache was more common in perinatal stroke (40%) than healthy participants (13%) but was mild and self-limiting. Tolerability improved over time with side-effect frequency decreasing by >50%. Robotic TMS motor mapping was well-tolerated though neck pain was more common than with manual TMS (33% vs 3%). Across 612 tDCS sessions including 92 children, tolerability was favourable with mild itching/tingling reported in 37%.

CONCLUSIONS

Standard non-invasive brain stimulation paradigms are safe and well-tolerated in children and should be considered minimal risk. Advancement of applications in the developing brain are warranted. A new and improved pediatric NIBS safety and tolerability form is included.

摘要

背景

非侵入性脑刺激技术正在被越来越多地用于探索神经生理学并调节大脑功能。尽管非侵入性脑刺激具有很高的科学和治疗潜力,但在发育中的大脑中的应用经验有限。

目的

确定在各种刺激模式和儿科人群中,使用非侵入性神经刺激对儿童的安全性和耐受性。

方法

我们的儿科学术机构于 2008 年建立了非侵入性脑刺激计划。多学科神经生理学研究包括单脉冲和双脉冲经颅磁刺激(TMS)方法。使用机器人 TMS 进行运动映射。干预性试验包括重复经颅磁刺激(rTMS)和经颅直流电刺激(tDCS)。所有参与者均前瞻性地完成了标准化的安全性和耐受性测量。

结果

在 10 年中,384 名儿童接受了脑刺激(中位数年龄 13 岁,范围 0.8-18.0 岁)。人群包括正常发育(n=118)、围产期中风/脑瘫(n=101)、轻度创伤性脑损伤(n=121)、神经精神障碍(n=37)和其他(n=7)。没有发生严重不良事件。辍学率很低(<1%)。尽管有 100 多名参与者患有脑损伤和/或癫痫,但没有报告癫痫发作。单脉冲和双脉冲 TMS(542340 次刺激)和 rTMS(300 万次刺激)之间的耐受性相似且良好。围产期中风患者的 TMS 相关头痛(40%)比健康参与者(13%)更为常见,但头痛程度较轻且为自限性。随着时间的推移,耐受性得到改善,副作用的频率降低了>50%。机器人 TMS 运动映射耐受性良好,尽管颈部疼痛比手动 TMS 更常见(33% vs 3%)。在包括 92 名儿童在内的 612 次 tDCS 治疗中,耐受性良好,37%的患者报告有轻度瘙痒/刺痛感。

结论

标准的非侵入性脑刺激方案在儿童中是安全且耐受良好的,应被视为低风险。在发育中的大脑中应用的进一步发展是合理的。本文提供了一种新的、经过改进的儿科非侵入性脑刺激安全性和耐受性表格。

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