Transcranial Temporal Interference Stimulation for Children With Autism Spectrum Disorders
Recruiting now · Not applicable
Conditions studied: Autism Spectrum Disorder
In brief
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.
Key facts
- Study ID
- NCT07625748
- Run by
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- People needed
- 16
- Starts
- 2026-05-25
- Expected to finish
- 2026-10-05
- Last updated by the study team
- 2026-06-04
Who can join
Age: 4 and older, up to 10. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Fei Li — Shanghai, Shanghai Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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