Accelerated theta-burst stimulation over the motor cortex improves social communication impairment in children with autism spectrum disorder: An open-label trial

Abstract

Background Social communication impairment (SCI) is a defining feature in autism spectrum disorder (ASD) but remains difficult to treat. Emerging evidence suggests that repetitive transcranial magnetic stimulation (rTMS) is a potential method for treating this aspect of ASD, but the stimulation protocols used vary widely, and limited effects of these protocols on SCI have been reported, particularly in younger children with ASD. Thus, we developed an accelerated rTMS protocol and investigated its feasibility, efficacy and potential neural mechanism for the treatment of SCI in ASD children. Methods In the open-label study, thirty children aged 4–10 with ASD received accelerated theta-burst stimulation (a-cTBS) over the motor cortex for 5 consecutive days. Before and after the intervention, all participants underwent a battery of clinical assessments regarding SCI, and 26 of them cooperated and participated in the collection of electroencephalogram (EEG) data. The primary clinical efficacy outcome was the Social Responsiveness Scale (SRS) score. Results All participants completed the trial and the adverse effects were low-incidence and mild. Repeat measurement analysis showed a significant improvement in the Social Responsiveness Scale (SRS) score with a mean decrease of 12.77 (95% CI 7.58 to 17.95; P < .001) between pre-intervention and post-intervention, and 16.60 (95% CI 11.47 to 21.73; P < .001) between pre-intervention and one-month follow-up, respectively, and the improvement was associated with the observed EEG signal changes of right temporoparietal region. Paired tests showed significant increases in language-related indicators scores from baseline to the one-month follow-up (all P < 0.05). Conclusions This study indicated that a-cTBS over the motor cortex is a safe, feasible and efficient protocol for treating SCI in children with ASD, and provided further evidence for the association of the motor cortex with the social/language network. Trial registration The trial was registered at ClinicalTrials.gov (NCT05472870) on 22th July, 2022.