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 range4 Years – 10 Years
SexALL
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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
✕. 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 mood disorders, etc.)
What they're measuring
1
Social Responsiveness Scale, SRS-2
Timeframe: Baseline, 4 weeks after completion of 5-day intervention