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Temporal Pole Transcranial Alternating Current Stimulation for Children With Autism Spectrum Disorder

NCT07045584 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-03-25

No results posted yet for this study

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

Conditions

Interventions

DEVICE

Transcranial Alternating Current Stimulation

Intervention Group（tACS）: Receive tACS stimulation targeting the temporal pole, with stimulation frequency of 40Hz, using adapter power supply: voltage 9V, current set at 1.5mA, 6 times/day, 20min/session with 20min intervals between sessions, lasting for 5 days;

DEVICE

transcranial Temporal Interference Stimulation

Intervention Group（tTIS）: Receive tTIS targeting the temporal pole, 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;

Sponsors & Collaborators

  • Fei Li

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2025-09-30
Completion
2025-10-07

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07045584 on ClinicalTrials.gov