Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Phase
Not applicable
Started
2026-05-25
Last updated
2026-06-04
Condition(s) studied
Autism Spectrum Disorder
Investigational drug(s) / intervention(s)
transcranial Temporal Interference Stimulation
transcranial Temporal Interference Stimulation: Receive tTIS targeting the anterior middle temporal gyrus with stimulation frequency of 2040/2000HZ, using battery power supply: voltage 12V, current set at 1.5mA, 6 times/day, 20min/session with 20min intervals between sessions, lasting for 5 days.
Study 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.
Eligibility
Sex
ALL
Min age
4 Years
Max age
10 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Completion of the tTIS intervention protocol — During the 5-day intervention The proportion of participants who complete all scheduled tTIS sessions according to the predefined stimulation protocol during the 5-day intervention.
Number of participants with adverse events — From the start of the intervention to 4 weeks after completion of the 5-day intervention. The number and proportion of participants who experience adverse events during the study period.
Trial sites (1)
Facility
City
Region
Status
Fei Li
Shanghai
Shanghai Municipality
Recruiting
More Xinhua Hospital, Shanghai Jiao Tong University School of Medicine trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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