Transcranial Temporal Interference Stimulation for Children With Autism Spectrum Disorders (NCT07625748) | Clinical Trial Compass
RecruitingNot Applicable
Transcranial Temporal Interference Stimulation for Children With Autism Spectrum Disorders
China16 participantsStarted 2026-05-25
Plain-language summary
The goal of this single-blinded, randomized controlled trial is to assess the safety, tolerability, and feasibility of tTIS for children with ASD. The main question it aims to answer is:
\- Is tTIS safe, tolerable, and feasible for use for children with autism spectrum disorder?
Researchers will compare tTIS group with control group to explore the safety and feasibility of the transcranial electrical stimulation for children with autism.
Participants will:
* tTIS group: undergo 5 days of temporal tTIS.
* Sham group: undergo 5 days of temporal tTIS without low-frequency envelope.
From baseline to 4 weeks after intervention completion, subjects will be followed up regarding clinical symptoms and adverse events:
* Primary Outcome Measures: Safety and feasibility of tTIS, assessed by adverse events, treatment completion rate, adherence to the stimulation protocol and tolerability.
* Secondary/Exploratory Outcome Measures: Changes in SRS-2 total scores and other clinical measures related to language, adaptive functioning, and cognition.
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
* Meeting the diagnostic criteria for ASD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and confirmed by the Autism Diagnostic Observation Schedule (ADOS) and/or the Autism Diagnostic Interview-Revised (ADI-R)
* Full Scale Intelligence Quotient (FSIQ) ≥50
* Signed informed consent form
Exclusion Criteria:
* Individuals with metal implants in the body
* Individuals with neurological disorders such as epilepsy
* Those requiring surgical treatment due to structural abnormalities indicated by brain MRI examination
* Those diagnosed with genetic or chromosomal abnormalities
* Individuals with mental illness (such as early-onset schizophrenia)
* Those with severe cardiac disease
* Individuals with increased intracranial pressure
* Those currently participating in other clinical trials
* Those who received new intervention protocols 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
Completion of the tTIS intervention protocol
Timeframe: During the 5-day intervention
2
Number of participants with adverse events
Timeframe: From the start of the intervention to 4 weeks after completion of the 5-day intervention.
Trial details
NCT IDNCT07625748
SponsorXinhua Hospital, Shanghai Jiao Tong University School of Medicine