TMS2025

Our group previously explored a 5-day accelerated continuous theta-burst stimulation (a-cTBS) targeting the left primary motor cortex (M1) protocol that is feasible and safe in children with autism spectrum disorder (ASD) aged 4-10 years (General Psychiatry, 2025). We hypothesized that this a-cTBS intervention could moderate social communication impairment in children with ASD. This multicenter, randomised, sham controlled clinical trial (ClinicalTrials.gov, NCT05927792) aimed to investigate the safety and efficacy of this a-cTBS for children with ASD. The primary outcome was the change in the total score of the Social Responsiveness Scale, Second Edition (SRS-2, school-age version) from baseline (T0) to post-intervention (T1), and from T0 to 1-month follow-up visit (T2). Secondary outcomes included changes from T0 to T2 in the composite score and domain standard scores (communication, daily living skills, and socialization) of the Vineland Adaptive Behaviour Scale, Third Edition (Parent/Caregiver Form). The Clinical Global Impression of Improvement scale was applied to assess overall autistic symptom change of the child at T1 and T2, compared to the pre-intervention status. Language improvements were assessed from T0 to T2 using three measures: the Multilingual Assessment Instrument for Narratives, the Chinese Communicative Development Inventory, and the Peabody Picture Vocabulary Test. Secondary outcomes also included changes in the five SRS-2 subscales: social awareness, social cognition, social communication, social motivation, and restricted interests and repetitive behaviours. Safety outcomes included adverse events within the study period. A total of 200 participants were recruited from 3 centers across 3 provinces in China (Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine [Shanghai], Qilu Hospital of Shandong University [Shandong], and Zhengzhou Children's Hospital Affiliated to Zhengzhou University [Henan]) between July 2023 and September 2024. This trial showed that compared to sham, the a-cTBS group showed significantly greater reductions in SRS-2 scores at both post-intervention and 1-month follow-up. Reported adverse events were all mild to moderate and resolved without intervention. The Files includes the analysis dataset used for the main and sensitive analyses reported in the manuscript, and the analysis code. Please refer to the data dictionary for definition of all relevant variables. We also attached the corresponding output files generated by running the code. All analyses were conducted using R version 4.5.2.