Autism Spectrum DisorderTMS for ASDNCT07910305
Transcranial Magnetic Stimulation (TMS) for Autism Spectrum Disorder
A study testing Individualized Cerebellar-Targeted Repetitive Transcranial Magnetic Stimulation in people with Autism Spectrum Disorder and TMS, run by Sir Run Run Shaw Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Autism Spectrum Disorder, TMS
- What is being tested?
- Individualized Cerebellar-Targeted Repetitive Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Aged 6-18 years.
- Meet the diagnostic criteria for autism spectrum disorder (ASD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
- Have a Childhood Autism Rating Scale (CARS) score >30.
- Voluntarily agree to participate in the study and provide written informed consent. For participants who are unable to read or sign the informed consent form due to a lack of legal capacity or other reasons, or for participants who are minors, informed consent must be obtained from their legally authorized representatives or legal guardians.
Who cannot join
- Presence of severe medical conditions or physical disorders, including but not limited to congenital heart disease, thyroid disorders, hepatic or renal dysfunction, and visual or hearing impairments.
- Presence of severe neurological disorders, a documented family history of such disorders, or potential neurological risks, including but not limited to traumatic brain injury, encephalitis, epilepsy, febrile seizures, birth-related injuries, or abnormal electroencephalographic (EEG) findings.
- Presence of confirmed or suspected genetic disorders, such as trisomy 21 (Down syndrome) or fragile X syndrome.
- Diagnosis of other developmental disorders, such as isolated intellectual disability, isolated language developmental disorder, or selective mutism.
- Diagnosis of other severe psychiatric disorders, such as schizophrenia or bipolar disorder.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang
Dan dan Chen, 15868417995, dandan5115@126.com
About this study
Official title: Cerebellar-Targeted Repetitive Transcranial Magnetic Stimulation (rTMS) for Autism Spectrum Disorder: A Novel Treatment Approach
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.
- Conditions
- Autism Spectrum Disorder, TMS
- Being tested
- Individualized Cerebellar-Targeted Repetitive Transcranial Magnetic Stimulation
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized Cerebellar-Targeted Repetitive Transcranial Magnetic StimulationDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Individualized Cerebellar-Targeted rTMS | Experimental | 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. Receives: Device: Individualized Cerebellar-Targeted Repetitive Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline and Week 2
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Sir Run Run Shaw HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei Chen, Principal investigator, Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07910305
- Sponsor's protocol ID
- SRRSH2026-0394
- Acronym
- TMS for ASD
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebellar-Targeted Repetitive Transcranial Magnetic Stimulation (rTMS) for Autism Spectrum Disorder: A Novel Treatment Approach
- ClinicalTrials.gov ID
- NCT07910305
- Acronym / sponsor ID
- TMS for ASD / SRRSH2026-0394
- Conditions
- Autism Spectrum Disorder, TMS
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 2 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individualized Cerebellar-Targeted rTMS | Experimental | Device: Individualized Cerebellar-Targeted Repetitive Transcranial Magnetic StimulationParticipants 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. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Aged 6-18 years.
- Meet the diagnostic criteria for autism spectrum disorder (ASD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
- Have a Childhood Autism Rating Scale (CARS) score >30.
- Voluntarily agree to participate in the study and provide written informed consent. For participants who are unable to read or sign the informed consent form due to a lack of legal capacity or other reasons, or for participants who are minors, informed consent must be obtained from their legally authorized representatives or legal guardians.
Key exclusion criteria (5 listed)
- Presence of severe medical conditions or physical disorders, including but not limited to congenital heart disease, thyroid disorders, hepatic or renal dysfunction, and visual or hearing impairments.
- Presence of severe neurological disorders, a documented family history of such disorders, or potential neurological risks, including but not limited to traumatic brain injury, encephalitis, epilepsy, febrile seizures, birth-related injuries, or abnormal electroencephalographic (EEG) findings.
- Presence of confirmed or suspected genetic disorders, such as trisomy 21 (Down syndrome) or fragile X syndrome.
- Diagnosis of other developmental disorders, such as isolated intellectual disability, isolated language developmental disorder, or selective mutism.
- Diagnosis of other severe psychiatric disorders, such as schizophrenia or bipolar disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized Cerebellar-Targeted Repetitive Transcranial Magnetic StimulationParticipants 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). | Device | Individualized Cerebellar-Targeted rTMS |
Primary outcome
Change in Social Responsiveness Scale (SRS) Total Score From Baseline to Week 2
Time frame: Baseline and 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).
5 secondary outcomes
Change in Social Responsiveness Scale (SRS) Total Score From Baseline to Week 12
Time frame: Baseline and Week 12
Change in Repetitive Behavior Scale-Revised (RBS-R) Total Score From Baseline
Time frame: Baseline, Week 2, and Week 12
Change in Strengths and Difficulties Questionnaire (SDQ) Total Difficulties Score From Baseline
Time frame: Baseline, Week 2, and Week 12
Change in Cerebellar Functional Connectivity Assessed by Resting-State Functional MRI
Time frame: Baseline, Week 2, and Week 12
Genetic Variants Identified Through Peripheral Blood Genotyping
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wei Chen principal investigator
Sir Run Run Shaw Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized Cerebellar-Targeted Repetitive Transcranial Magnetic Stimulation in people with Autism Spectrum Disorder and TMS, run by Sir Run Run Shaw Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dan Dan Chen (15868417997, dandan5115@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Social Responsiveness Scale (SRS) Total Score From Baseline to Week 2 (time frame: Baseline and Week 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.