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Transcranial Temporal Interference Stimulation for Children With Autism Spectrum Disorders

RecruitingNAAges 4 Years - 10 YearsAllXinhua Hospital, Shanghai Jiao Tong University Sc…
NCT07625748 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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. * Se

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📋 Eligibility rules (as published)
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.
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What it tests

  • transcranial Temporal Interference Stimulation
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Where

1 site
Fei Li
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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