Accelerated continuous theta burst stimulation targeting left primary motor cortex for children with autism spectrum disorder: multicentre randomised sham controlled trial
作者:Hangyu Tan, Tai Ren, Aihua Cao, Shuanfeng Fang, Lin Deng, Bo Hu, M M Wang, Ye Cheng, Xi Zhang, Y L Li, Yixia Zhang, Lingli Zhang, Luan Chen, Wei Zhou, Qianlong Zhang, Jiong Li, Xin Zhou, Christelle Langley, Qiang Luo, J Zhang, Barbara J. Sahakian, Ti-Fei Yuan, Fēi Li · 发表于:BMJ · 年份:2026 · DOI:10.1136/bmj-2025-086295 · 被引用次数:2 · 研究领域:Transcranial Magnetic Stimulation Studies、Pain Management and Treatment、Autism Spectrum Disorder Research
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 ea...