Efficacy and Mechanism of Repetitive Transcranial Magnetic Stimulation in Children With Autism Sp… (NCT05927792) | Clinical Trial Compass
CompletedPhase 2/3
Efficacy and Mechanism of Repetitive Transcranial Magnetic Stimulation in Children With Autism Spectrum Disorders
China200 participantsStarted 2023-07-04
Plain-language summary
This study is a prospective, multicenter, randomized, single-blind controlled trial to enroll 200 children with autism spectrum disorders (ASD). The investigators hope to further explore the effectiveness of accelerated continuous theta-burst stimulation (a-cTBS) over the left primary motor cortex (M1) to improve core symptoms in ASD children based on a previous open-label clinical trial.
Who can participate
Age range
4 Years – 10 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Children aged 4-10 years old
* Meet the diagnostic criteria for ASD of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
* ASD Diagnosis confirmed by the Autism Diagnostic Observation Schedule (ADOS) or Autism Diagnostic Interview, Revised (ADI-R)
* IQ of 50 or above
* Provide written informed consents
Exclusion Criteria:
* With metal implants in the body
* History of epilepsy or other neurological disease
* Require surgical treatment due to structural abnormalities indicated by brain MRI
* Diagnosed with genetic and chromosomal abnormalities
* With psychiatric/mental disorder (e.g., very early-onset schizophrenia) other than ASD
* Suffer from serious heart disease and/or severe hearing impairment
* Intracranial hypertension
* Participating in other clinical trials
* Participants who received other interventions within 4 weeks prior to enrollment.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes of Social Responsiveness Scale, Second Edition (SRS-2) scores from pre-intervention to post-intervention
Timeframe: within 2 weeks before the intervention (pre-intervention), within 3 days after the completion of the intervention course (post-intervention)
2
Changes of Social Responsiveness Scale, Second Edition (SRS-2) scores from pre-intervention to 1 month follow-up
Timeframe: within 2 weeks before the intervention (pre-intervention), 1 month following the last intervention session (one month follow-up)
Trial details
NCT IDNCT05927792
SponsorXinhua Hospital, Shanghai Jiao Tong University School of Medicine