Accelerated continuous theta burst stimulation targeting left primary motor cortex for children with autism spectrum disorder: multicentre randomised sham controlled trial.

Methods

Multicentre randomised sham controlled trial.

多中心随机安慰剂对照试验。

Three academic hospitals across three provinces in China, conducted from July 2023 to October 2024.

中国三个省份的三家教学医院从2023年7月至2024年10月进行了研究。

200 children aged 4-10 years with autism spectrum disorder (167 boys and 33 girls) all with a full scale intelligence quotient ≥50.

200名年龄在4至10岁之间的自闭症谱系障碍儿童（167名男孩和33名女孩），他们的全量表智商均≥50。

Participants were randomised 1:1 to receive active a-cTBS (n=100) or sham (n=100) treatment stratified by full scale intelligence quotient (≥70 or <70) and study site.

受试者按1:1的比例随机分为接受主动a-cTBS（n=100）组或安慰剂（n=100）组，根据全量表智商（≥70或<70）和研究地点进行分层。

Participants received 10 sessions each day for five consecutive days, targeting the left primary motor cortex.

参与者每天接受10次治疗，连续五天，针对左侧初级运动皮层。

Participants and evaluators were masked to interventions.

参与者和评估者对干预措施进行了盲法处理。

Two primary outcomes were assessed using the Social Responsiveness Scale, second edition (SRS-2): changes in social communication impairment from baseline to post-intervention and from baseline to one month follow-up.

使用社交反应性量表第二版（SRS-2）评估了两项主要结果：从基线到干预后以及从基线到随访一个月的社会交流障碍的变化。

Primary analyses were conducted on a modified intention-to-treatpopulation, including participants who received at least one stimulation session.

主要分析是在改良意向治疗人群中进行的，包括至少接受了一次刺激治疗的参与者。

Secondary outcomes included language improvements assessed from baseline to one month follow-up and changes in SRS-2 subscales.

次要结果包括从基线到一个月随访期间的语言改善评估以及SRS-2子量表的变化。

Results

Of the 200 participants, 198 were included in the modified intention-to-treatanalysis (99 in each group) and 193 completed the full intervention.

在200名参与者中，有198名被纳入改良意向治疗分析（每组99人），并且有193名完成了整个干预。

Compared with the sham group, the a-cTBS group showed significantly greater reductions in SRS-2 scores post-intervention (-6.25, 95% confidence interval-8.69 to -3.81; Cohen's d -0.92; P<0.001) and at one month follow-up (-6.17, -8.65 to -3.70; -0.90; P<0.001).

与假刺激组相比，a-cTBS组在干预后（-6.25，95%置信区间-8.69至-3.81；Cohen's d -0.92；P<0.001）和一个月随访时（-6.17，-8.65至-3.70；-0.90；P<0.001）的SRS-2评分显著降低。

Secondary outcomes also favoured a-cTBS, with significant improvements observed in language abilities (Cohen's d 0.12-0.47; all P<0.02; measured by Multilingual Assessment Instrument for Narratives).

次要结果也倾向于支持 a-cTBS，观察到语言能力有显著改善（Cohen's d 0.12-0.47；所有 P<0.02；通过多语言叙述评估工具测量）。

Reported adverse events were all mild to moderate and resolved without intervention.

报告的不良事件均为轻度至中度，并且无需干预即自行缓解。

Conclusions

A five day a-cTBS protocol targeting the left primary motor cortex significantly improved social communication in children with autism spectrum disorder and showed a favourable safety profile.

针对左侧初级运动皮层的五天交替性经颅磁刺激(a-cTBS)方案显著改善了自闭症谱系障碍儿童的社会交流能力，并显示出良好的安全性。

These findings support a-cTBS as a viable and scalable therapeutic option for children with autism spectrum disorder.

这些发现支持将a-cTBS作为自闭症谱系障碍儿童的一种可行且可扩展的治疗选择。

trial_registration

ClinicalTrials.gov NCT05927792.

ClinicalTrials.gov NCT05927792。