Temporal Interference Stimulation for Children with Autism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a 5-week, single-blinded, randomized trial enrolling 16 children with autism to compare temporal interference stimulation (tTIS) against a sham control over five consecutive days. Participants in the active arm receive 1.5 mA stimulation at 2040/2000 Hz with a 40 Hz envelope for 20 minutes per session, while the sham group receives identical setup without the 40 Hz envelope. Primary outcomes focus on safety, tolerability, completion rate, and protocol adherence, with secondary outcomes including change in SRS-2 scores from baseline to end of treatment and to four weeks post-intervention. Assessments include baseline measurements, IQ testing, clinical scales, and resting-state EEG, with follow-up on symptoms, imaging, and adverse events through four weeks after completion. The study aims to determine feasibility of tTIS in pediatric ASD and to gather preliminary signals on social responsiveness changes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Fei Li
  Shanghai, Shanghai Municipality, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.