Abstract:Objective To explore the clinical efficacy of repetitive transcranial magnetic stimulation (rTMS) on the children with autism spectrum disorder (ASD) comorbid with sleep disorder. Methods A total of 58 children with ASD who met the diagnostic criteria of American Diagnostic and Statistical Manual of Mental Disorder, Fifth Edition (DSM-5) were selected through recruitment advertisements published in the Children Outpatient Department and online platform of Tianjin Anding Hospital from October 2018 to June 2021. All selected children were (5.51±1.28) years old, and were divided into the trail group and the control group randomly. The bilateral dorsolateral prefrontal cortex (DLPFC) of the participants in the trail group were stimulated with high frequency (10 Hz) on the left + low frequency (1 Hz) on the right, while the participants in the control group received the sham condition with the same stimulating sites & duration. All the participants were intervened for 4 weeks. The childhood autism rating scale (CARS) & Children's Sleep Habits Questionnaire (CSHQ) were used to assess the symptoms of ASD before intervention, 2 weeks and 4 weeks after intervention. The data were analyzed by ANOVA of repeated measurement data. Results There was no statistical difference between the two groups on age, gender composition, CARS score and CSHQ score (P > 0.05). The results of repeated measurement ANOVA showed that in terms of CARS score, there was no significant difference in the main effect of the group (F(1,55)=0.108, P=0.743) and the main effect of the course of treatment (F(2,54)= 0.667, P=0.515), however, there was statistical significance for the interaction between group and course (F(2,54)=28.757, P < 0.001). In terms of CSHQ, the differences on the main effect of group (F(1,55)=4.489, P=0.039), the main effect of the course of treatment (F(2, 54)=7.735, P=0.001), and the interaction between group and course (F(2, 54)=138.478, P< 0.001) were all statistically significant. Through simple effect analysis and further analysis of the interaction between the group and the course of treatment, it was found that the total scores of CARS (pre-intervention vs post-two-week intervention: t=8.328; pre-intervention vs post-fourweek intervention: t=8.375; post-two-week intervention vs post-four-week intervention: t=4.783; P < 0.001) and CSHQ (pre-intervention vs. post-two-week intervention: t=13.257; pre-intervention vs post-four-week intervention: t=25.902; post-two-week intervention vs post-four-week intervention: t=12.840; P < 0.001) in the trail group were compared at different time points, and the differences were statistically significant, while those in the control group were compared at different time points, and the differences were not statistically significant. The scores of the subscales of CSHQ in the trail group improved to varying degrees with the extension of the intervention. Conclusions The protocols of rTMS stimulation (left-side high-frequency + right-side lowfrequency) on bilateral DLPFC of children with ASD could improve the core symptoms and sleep disorder of ASD simultaneously, and it began to take effect as short as two weeks (10 times).