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Magnetic brain stimulation aimed at the cerebellum for children and teens with autism

Tests magnetic stimulation of the cerebellum in children and teenagers with autism spectrum disorder.

Key facts

Who runs it
Sir Run Run Shaw Hospital
Where
Hangzhou, ChinaSee the site
Trial code
Registry title
Transcranial Magnetic Stimulation (TMS) for Autism Spectrum Disorder
Status
Not yet recruiting
People taking part
120 people, planned
Started
1 Nov 2026
Expected to end
31 Dec 2028
Type of study
Interventional
Treatments tested
  • Individualized Cerebellar-Targeted Repetitive Transcranial Magnetic Stimulation
Record updated
3 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children and teenagers aged 6 to 18 with autism spectrum disorder who would get a brain stimulation treatment (rTMS) aimed at the cerebellum.

Age
6 to 18 years
Sex
All sexes can join.
Disease stage
Autism spectrum disorder diagnosed by DSM-5 criteria, with a Childhood Autism Rating Scale (CARS) score above 30.

Main reasons for not taking part

  • Severe medical conditions such as congenital heart disease, thyroid disorders, liver or kidney problems, or vision or hearing impairment
  • Severe neurological disorders or risks, such as head injury, encephalitis, epilepsy, febrile seizures or abnormal EEG
  • Confirmed or suspected genetic disorders, such as trisomy 21 (Down syndrome) or fragile X syndrome
  • Other developmental disorders, such as isolated intellectual disability, isolated language developmental disorder or selective mutism
  • Other severe psychiatric disorders, such as schizophrenia or bipolar disorder

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • 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 take part

  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 6 and 18 years old?

Where in China

  • Sir Run Run Shaw Hospital Zhejiang University School of MedicineHangzhou, ChinaContact: Dan dan ChenNo longer taking part

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The group in the trial

  • Individualized Cerebellar-Targeted rTMSTreatment being tested

    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.

    Treatment: Individualized Cerebellar-Targeted Repetitive Transcranial Magnetic Stimulation

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Cerebellar-Targeted Repetitive Transcranial Magnetic Stimulation (rTMS) for Autism Spectrum Disorder: A Novel Treatment Approach
Plain-language title
Magnetic brain stimulation aimed at the cerebellum for children and teens with autismGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 13 November 2026.
Fit questions
Built from NCT07910305, who can take part
Record updated
3 November 2026