An interventional study of Individualized Cerebellar-Targeted Repetitive Transcranial Magnetic Stimulation in Autism Spectrum Disorder and TMS, sponsored by Sir Run Run Shaw Hospital. Not yet recruiting at 1 site in China. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Sir Run Run Shaw Hospital · Not applicable, Interventional, and Treatment
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.
1,724 studies on the registry are indexed under Autism Spectrum Disorder; 500 are open to participants now.
This study's planned enrollment of 120 is above the median of 52 across 1,368 interventional studies indexed under Autism Spectrum Disorder.
Browse Autism Spectrum Disorder studies →Sir Run Run Shaw Hospital is the lead sponsor of 135 studies on the registry; 72 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Diagnosis of other severe psychiatric disorders, such as schizophrenia or bipolar disorder.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this arm will receive individualized cerebellar-targeted repetitive transcranial magnetic stimulation (rTMS) guided by MRI-based neuronavigation. The stimulation will be delivered using an intermittent theta-burst stimulation (iTBS) protocol at 90% of the resting motor threshold (RMT). Each treatment day will consist of two stimulation sessions separated by a 15-minute rest interval, delivering a total of 1,200 pulses per day. Treatment will be administered five days per week for two consecutive weeks, resulting in a total of 10 treatment days. Clinical assessments and MRI examinations will be performed at baseline, week 2, and week 12 to evaluate treatment-related changes in ASD symptoms and brain function.
Device: 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).
Change in Social Responsiveness Scale (SRS) Total Score From Baseline to Week 2
The Social Responsiveness Scale (SRS) is a caregiver-reported questionnaire used to assess social communication and interaction difficulties in individuals with autism spectrum disorder. The scale consists of 65 items, each rated from 0 to 3, with a total score ranging from 0 to 195. Higher scores indicate greater severity of social impairment. The primary outcome is the change in SRS total score from baseline to week 2 following individualized cerebellar-targeted repetitive transcranial magnetic stimulation (rTMS).
Time frame: Baseline and Week 2
Change in Social Responsiveness Scale (SRS) Total Score From Baseline to Week 12
The Social Responsiveness Scale (SRS) consists of 65 items rated from 0 to 3, with a total score ranging from 0 to 195. Higher scores indicate greater severity of social impairment. This outcome measures the change in SRS total score from baseline to week 12 to evaluate the persistence of treatment-related changes in social functioning.
Time frame: Baseline and Week 12
Change in Repetitive Behavior Scale-Revised (RBS-R) Total Score From Baseline
The Repetitive Behavior Scale-Revised (RBS-R) is a caregiver-reported questionnaire used to assess restricted and repetitive behaviors in individuals with autism spectrum disorder. It consists of 43 items, each rated from 0 to 3, with a total score ranging from 0 to 129. Higher scores indicate more severe repetitive behaviors. Changes in RBS-R total scores from baseline will be assessed following rTMS treatment.
Time frame: Baseline, Week 2, and Week 12
Change in Strengths and Difficulties Questionnaire (SDQ) Total Difficulties Score From Baseline
The Strengths and Difficulties Questionnaire (SDQ) is a caregiver-reported questionnaire used to assess emotional and behavioral difficulties in children and adolescents. It consists of 25 items across five subscales: emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior. The total difficulties score ranges from 0 to 40 and is calculated by summing the first four subscales. Higher scores indicate greater emotional and behavioral difficulties. Changes from baseline will be evaluated at weeks 2 and 12.
Time frame: Baseline, Week 2, and Week 12
Change in Cerebellar Functional Connectivity Assessed by Resting-State Functional MRI
Resting-state functional magnetic resonance imaging (rs-fMRI) will be performed to investigate changes in functional connectivity following individualized cerebellar-targeted rTMS. Functional connectivity between the cerebellum and cortical regions, particularly the medial prefrontal cortex, will be analyzed at baseline, week 2, and week 12. Changes in functional connectivity will be evaluated to explore potential neural mechanisms associated with treatment-related clinical improvements.
Time frame: Baseline, Week 2, and Week 12
Genetic Variants Identified Through Peripheral Blood Genotyping
Peripheral blood samples will be collected once at baseline for genetic testing and genotyping. Approximately 18 mL of blood will be collected from each participant in three tubes (approximately 6 mL per tube). Genetic analysis will be performed to identify and characterize genetic variants among participants with autism spectrum disorder (ASD). The results will be summarized according to the genetic variants and genotypes identified.
Time frame: Baseline
Plan to share: No — Individual participant data (IPD) will not be shared with external researchers due to privacy and confidentiality concerns, particularly given the inclusion of pediatric participants and the collection of sensitive neuroimaging, neuropsychological, and genetic data. All study data will be securely stored and managed in accordance with applicable ethical guidelines and institutional data protection policies.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.