Temporal Pole Transcranial Alternating Current Stimulation for Children With Autism Spectrum Diso… (NCT07045584) | Clinical Trial Compass
CompletedNot Applicable
Temporal Pole Transcranial Alternating Current Stimulation for Children With Autism Spectrum Disorder
China36 participantsStarted 2025-07-01
Plain-language summary
The goal of this open-label randomized controlledl trial is to explore the safety and efficacy of conventional transcranial alternating current stimulation (tACS) and transcranial temporal interference stimulation (tTIS) targeting the temporal pole in children with autism spectrum disorder (ASD) in China. The main questions it aims to answer are:
\*Can tACS and tTIS safely and effectively improve clinical symptoms in children with autism?
Researchers will compare the tACS group and tTIS group with control group to explore the safety, feasibility and efficacy of the transcranial electrical stimulation in children with autism.
Participants will:
* tACS group: undergo 5 days of temporal pole tACS
* tTIS group:undergo 5 days of temporal pole tTIS
* Control group: receive routine rehabilitation training during the study period.
From baseline to 4 weeks after intervention completion, subjects will be followed up regarding clinical symptoms and adverse reactions:
* Safety Outcome Measures: adverse events
* Primary Efficacy Outcome Measures: Social Responsiveness Scale (SRS-2) total scores
* Other clinical outcome measures related language, adapative function 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)
. Diagnosis 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
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
Social Responsiveness Scale, SRS-2
Timeframe: Baseline, 4 weeks after completion of 5-day intervention