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Transcranial Magnetic Stimulation (TMS) for Autism Spectrum Disorder
Sponsor: Sir Run Run Shaw Hospital
Summary
Autism spectrum disorder (ASD) is a neurodevelopmental disorder characterized by persistent difficulties in social communication and interaction, as well as restricted and repetitive patterns of behavior. Emerging evidence suggests that the cerebellum plays an important role in social cognition and behavioral regulation, and abnormalities in cerebellar structure and function may contribute to the pathophysiology of ASD.Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation technique that may modulate neural activity and functional connectivity within brain networks associated with ASD. However, the therapeutic effects of individualized cerebellar-targeted rTMS in children and adolescents with ASD remain unclear. This study aims to investigate the efficacy and safety of individualized cerebellar-targeted rTMS guided by magnetic resonance imaging (MRI) in children and adolescents with ASD. Additionally, the study will explore the effects of rTMS on brain structure and functional connectivity. This is a multicenter, single-arm, exploratory interventional study involving 120 participants aged 6 to 18 years who meet the DSM-5 diagnostic criteria for ASD. Participants will receive individualized cerebellar-targeted intermittent theta-burst stimulation (iTBS) guided by MRI-based neuronavigation for two consecutive weeks.Clinical assessments and MRI examinations will be conducted at baseline, week 2, and week 12. Clinical outcomes will be evaluated using the Social Responsiveness Scale (SRS), Repetitive Behavior Scale-Revised (RBS-R), and Strengths and Difficulties Questionnaire (SDQ). Adverse events associated with rTMS will also be monitored. Peripheral blood samples will be collected once at baseline for genetic testing and genotyping to characterize genetic variation among participants. The findings of this study may provide preliminary evidence regarding the feasibility, safety, and potential therapeutic effects of individualized cerebellar-targeted rTMS in children and adolescents with ASD.
Official title: Cerebellar-Targeted Repetitive Transcranial Magnetic Stimulation (rTMS) for Autism Spectrum Disorder: A Novel Treatment Approach
Key Details
Gender
All
Age Range
6 Years - 18 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2026-11-01
Completion Date
2028-12-31
Last Updated
2026-11-03
Healthy Volunteers
No
Conditions
Interventions
Individualized Cerebellar-Targeted Repetitive Transcranial Magnetic Stimulation
Participants will receive individualized cerebellar-targeted repetitive transcranial magnetic stimulation (rTMS) guided by MRI-based neuronavigation. Individualized stimulation targets will be determined through MRI-based image registration. Stimulation will be delivered using an intermittent theta-burst stimulation (iTBS) protocol consisting of bursts of three pulses at 50 Hz, with 2-second stimulation trains followed by 8-second rest intervals. Stimulation intensity will be set at 90% of the resting motor threshold (RMT). Participants will receive two stimulation sessions per day, separated by a 15-minute interval, for a total of 1,200 pulses daily. Treatment will be administered five days per week for two consecutive weeks (10 treatment days).
Locations (1)
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China