NCT07045584Completed
Temporal Pole Transcranial Alternating Current Stimulation for Children With Autism Spectrum Disorder
Temporal Pole Transcranial Alternating Current Stimulation for Children With Autism Spectrum Disorder: A Randomized Controlled Open-Label Trial
Source: ClinicalTrials.gov · Last updated 25 Mar 2026
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 36 (actual)
- First submitted
- 29 May 2025
- Start date
- 1 Jul 2025
- Primary completion date
- 30 Sept 2025
- Lead sponsor
- Fei Li
- Diseases
- Autism
- NCT number
- NCT07045584
What you commit to
- Study type: Interventional
- Participants enrolled: 36
- From 1 Jul 2025 to the primary completion date, 30 Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Individuals with metal implants in the body
- Those requiring surgical treatment due to structural abnormalities indicated by brain MRI examination
- Those who received new intervention protocols within 4 weeks prior to enrollment.
Other illness
- Individuals with neurological disorders such as epilepsy
- Individuals with mental illness (such as mood disorders, etc.)
- Those with severe cardiac disease
Other
- Those diagnosed with genetic or chromosomal abnormalities
- Individuals with increased intracranial pressure
- Those currently participating in other clinical trials
Who the study is looking for
- 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
Age in the registry: 4 years to 10 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Xinhua Hospital Affiliated To Shanghai Jiao tong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.