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

NCT07045584 | Completed DMC

• 1 other identifier: XHEC-C-2025-090-3
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

Autism Spectrum Disorder

Keywords

Autism Spectrum Disorder (ASD); Transcranial Alternating Current Stimulation (tACS); Transcranial temporal interference stimulation (tTIS); Children; Intervention

Outcome Measures

Primary Outcomes (1)

• Social Responsiveness Scale, SRS-2

  The SRS-2 is primarily used to assess symptoms associated with ASD. Compared to other autism assessment tools, the SRS-2 stands out for its focus on quantifying the severity of social impairment, with higher scores indicating more autism symptoms and greater social disability.

  Baseline, 4 weeks after completion of 5-day intervention

Secondary Outcomes (7)

• SRS-2

  Baseline, after completion of 5-day intervention

• Childhood Autism Rating Scale (CARS)

  Baseline, 4 weeks after completion of 5-day intervention

• Chinese Communicative Development Inventory, CCDI

  Baseline, 4 weeks after completion of 5-day intervention

• Peabody Picture Vocabulory Test, PPVT

  Baseline, 4 weeks after completion of 5-day intervention

• Neuropsychological Assessment for Child, NEPSY-II

  Baseline, 4 weeks after completion of 5-day intervention

Other Outcomes (1)

• Several electroencephalography (EEG) parameters

  Baseline, after completion of 5-day intervention, 4 weeks after completion of 5-day intervention

Study Arms (3)

Intervention group(tACS)

EXPERIMENTAL

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 Alternating Current Stimulation

Control group

NO INTERVENTION

Receive routine rehabilitation training during the study period

Intervention group(tTIS)

EXPERIMENTAL

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

Device: transcranial Temporal Interference Stimulation

Interventions

Transcranial Alternating Current Stimulation DEVICE

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;

Intervention group(tACS)

transcranial Temporal Interference Stimulation DEVICE

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;

Intervention group(tTIS)

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.)
• 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.

Sponsors & Collaborators

• Fei Li: lead

Study Sites (1)

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200000, China

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinding of Clinical Scale Assessors
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician, Doctoral Supervisor

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: July 1, 2025
• Study Start: July 1, 2025
• Primary Completion: September 30, 2025
• Study Completion: October 7, 2025
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)