Long Junzi, Niu Maoyuan, Liao Xingxing, Han Kaiyue, Chen Jiarou, Su Wenlong, Wang Xianna, Liu Jianjun, Zhang Yan, Zhang Hao
School of Rehabilitation, Capital Medical University, Beijing, China.
Department of Neurorehabilitation, Beijing Boai Hospital, China Rehabilitation Research Center, Beijing, China.
Front Psychiatry. 2025 Mar 31;16:1549982. doi: 10.3389/fpsyt.2025.1549982. eCollection 2025.
BACKGROUND: Autism spectrum disorders (ASD) are common neurodevelopmental disorders, mainly caused by disrupted excitation/inhibition balance and synaptic plasticity. Intermittent theta burst stimulation (iTBS) is a variant of excitatory repetitive transcranial magnetic stimulation, inducing long-term potentiation-like plasticity. In recent years, there has been a growing interest in high-dose iTBS as a therapeutic tool for psychiatric disorders. We aim to preliminarily investigate the feasibility, safety, and efficacy of high-dose iTBS in children with autism spectrum disorder (ASD). METHODS: A randomized controlled pilot trial with a 4-week intervention will be conducted. Forty children with ASD will be randomized into either the intervention or control group. The intervention group will receive 5400-pulse iTBS per day, while the control group will receive sham iTBS. Feasibility will be evaluated through recruitment, intervention adherence, and assessment completion. Safety will be assessed by comparing the rates of drop-outs attributed to adverse events and the rates of serious adverse events The efficacy outcomes include the Autism Behavior Checklist, Social Responsiveness Scale, 2nd Edition, Childhood Autism Rating Scale, Autism Treatment Evaluation Checklist and Repetitive Behavior Scale-Revised. Resting-state electroencephalogram and functional near-infrared spectroscopy will be employed to quantify alterations in functional brain connectivity and cerebral haemodynamics. Salivary levels of oxytocin, growth hormone, insulin-like growth factor 1, and insulin-like growth factor binding protein 3 are measured to reflect the biochemical response to iTBS. These indicators will be assessed at baseline and at the end of the intervention. DISCUSSION: This trial will evaluate the feasibility, safety, and efficacy of high-dose iTBS treatment in children with ASD. The proposed study will provide pilot data to inform the feasibility and design of larger sample-size trials. CLINICAL TRIAL REGISTRATION: http://www.chictr.org.cn, identifier ChiCTR2400089757.
背景：自闭症谱系障碍（ASD）是常见的神经发育障碍，主要由兴奋/抑制平衡破坏和突触可塑性受损引起。间歇性θ波爆发刺激（iTBS）是兴奋性重复经颅磁刺激的一种变体，可诱导长期增强样可塑性。近年来，高剂量iTBS作为一种精神疾病治疗工具的关注度日益增加。我们旨在初步研究高剂量iTBS治疗自闭症谱系障碍（ASD）儿童的可行性、安全性和疗效。 方法：将进行一项为期4周干预的随机对照试验。40名ASD儿童将被随机分为干预组或对照组。干预组每天接受5400次脉冲iTBS，而对照组接受假iTBS。将通过招募、干预依从性和评估完成情况来评估可行性。通过比较因不良事件导致的退出率和严重不良事件发生率来评估安全性。疗效指标包括自闭症行为量表、社会反应量表第二版、儿童自闭症评定量表、自闭症治疗评估清单和重复行为量表修订版。静息态脑电图和功能近红外光谱将用于量化功能性脑连接和脑血流动力学的变化。测量唾液中催产素、生长激素、胰岛素样生长因子1和胰岛素样生长因子结合蛋白3的水平，以反映对iTBS的生化反应。这些指标将在基线和干预结束时进行评估。 讨论：本试验将评估高剂量iTBS治疗ASD儿童的可行性、安全性和疗效。拟议的研究将提供试点数据，为更大样本量试验的可行性和设计提供参考。 临床试验注册：http://www.chictr.org.cn，标识符ChiCTR2400089757 。
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