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

Overview

1. Department of Developmental and Behavioural Paediatric and Child Primary Care & Ministry of Education, Shanghai Key Laboratory of Children’s Environmental Health, Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China
2. Department of Paediatrics, Qilu Hospital of Shandong University, Jinan, Shandong, China
3. Department of Developmental and Behavioural Paediatric & Child Primary Care, Zhengzhou Children’s Hospital affiliated to Zhengzhou University, Henan Children’s Hospital, Zhengzhou Children’s Hospital, Zhengzhou, Henan, China
4. Clinical Research and Innovation Unit, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
5. Department of Epidemiology, School of Public Health, Nanjing Medical University, Nanjing, China
6. Department of Psychiatry, University of Cambridge, Cambridge, UK
7. Behavioural and Clinical Neuroscience Institute, University of Cambridge, Cambridge, UK
8. Institute of Science and Technology for Brain-Inspired Intelligence, Ministry of Education-Key Laboratory of Computational Neuroscience and Brain-Inspired Intelligence, Fudan University, Shanghai, China
9. Shanghai Key Laboratory of Psychotic Disorders, Brain Health Institute, National Center for Mental Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine and School of Psychology, Shanghai, China

Abstract

Objectives: To investigate the efficacy and safety of a five day accelerated continuous theta burst stimulation (a-cTBS) protocol in improving social communication impairment in children with autism spectrum disorder.

Design: Multicentre randomised sham controlled trial.

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

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

Interventions: 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. Participants received 10 sessions each day for five consecutive days, targeting the left primary motor cortex. Participants and evaluators were masked to interventions.

Main outcome measures: 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. Primary analyses were conducted on a modified intention-to-treat population, including participants who received at least one stimulation session. Secondary outcomes included language improvements assessed from baseline to one month follow-up and changes in SRS-2 subscales.

Results: Of the 200 participants, 198 were included in the modified intention-to-treat analysis (99 in each group) and 193 completed the full intervention. 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). 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). Reported adverse events were all mild to moderate and resolved without intervention.

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

Trial registration: ClinicalTrials.gov NCT05927792

Reproduced under the paper's license (CC BY-NC), from the paper cited above.

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Data

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Data availability statement

The code used to analyse the data in the paper can be found in the supplementary appendix. The data underlying the findings in this paper are openly and publicly available and can be found at: https://osf.io/tg9me/overview. If problems are encountered accessing the data, please contact the corresponding author.

Reproduced under the paper's license (CC BY-NC), from the paper cited above.

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Recorded: type, language, journal, volume, pages, dates, 23 authors, 10 MeSH terms, 64 references.

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This paper

Tan, H., Ren, T., Cao, A., Fang, S., Deng, L., Hu, B., Wang, M., Cheng, Y., Zhang, X., Li, Y., Zhang, Y., Zhang, L., Chen, L., Zhou, W., Zhang, Q., Li, J., Zhou, X., Langley, C., Luo, Q., . . . Li, F. (2026). Accelerated continuous theta burst stimulation targeting left primary motor cortex for children with autism spectrum disorder: multicentre randomised sham controlled trial. BMJ (Clinical research ed.), 393, e086295. https://doi.org/10.1136/bmj-2025-086295

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