Transcranial Temporal Interference Stimulation for Children With Autism Spectrum Disorders

NCT07625748 | Recruiting

• 1 other identifier: XHEC-C-2026-109-1
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.
• Secondary/Exploratory Outcome Measures: Changes in SRS-2 total scores and other clinical measures related to language, adaptive functioning, and cognition.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (2)

• Completion of the tTIS intervention protocol

  The proportion of participants who complete all scheduled tTIS sessions according to the predefined stimulation protocol during the 5-day intervention.

  During the 5-day intervention

• Number of participants with adverse events

  The number and proportion of participants who experience adverse events during the study period.

  From the start of the intervention to 4 weeks after completion of the 5-day intervention.

Secondary Outcomes (9)

• SRS-2

  Baseline, after completion of 5-day intervention

• Childhood Autism Rating Scale (CARS)

  Baseline, 4 weeks after completion of 5-day intervention

• Social Responsiveness Scale, Second Edition (SRS-2)

  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

Other Outcomes (4)

• Change from baseline in alpha-band EEG power

  Baseline, immediately after completion of the 5-day intervention, and 4 weeks after completion of the 5-day intervention.

• Change from baseline in theta-band EEG power

  Baseline, immediately after completion of the 5-day intervention, and 4 weeks after completion of the 5-day intervention.

• Change from baseline in inter-trial phase coherence in the alpha band

  Baseline, immediately after completion of the 5-day intervention, and 4 weeks after completion of the 5-day intervention.

Study Arms (2)

Intervention group (tTIS)

EXPERIMENTAL

Receive tTIS targeting the anterior middle temporal gyrus, 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

Control group

SHAM COMPARATOR

Receive tTIS targeting the anterior middle temporal gyrus, with stimulation frequency of 2000/2000HZ(without 40Hz envelope compared to tTIS group), 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 Temporal Interference Stimulation DEVICE

Receive tTIS targeting the anterior middle temporal gyrus 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.

Control group; 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) 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

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 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.

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Fei Li

Shanghai, Shanghai Municipality, 200092, China

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: June 4, 2026
• Study Start: May 25, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): October 5, 2026
• Last Updated: June 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)