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

NCT ID: NCT07045584

Last Updated: 2025-07-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2025-11-30

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

Detailed Description

This research is a 5-week prospective, open-label, randomized controlled trial, planning to enroll 36 autistic children aged 4-10 with a full-scale intelligence quotient (FSIQ) of 50 or above. Children who satisfy all inclusion criteria without meeting any exclusion criteria, may be enrolled after their legal guardians provided the written informed consent.

Eligible subjects will be randomly divided into three groups: tACS group, tTIS group and control group. The tACS group will undergo 5 days of temporal pole tACS stimulation (1.5mA, 40Hz, 20min/session, 6 sessions/day); the tTIS group will undergo 5 days of temporal pole TI stimulation（1.5mA, 2040/2000Hz, 20min/session, 6 sessions/day）; the control group will receive routine rehabilitation training during the study period, including various rehabilitation services provided by the community.

At baseline, subjects will undergo physical measurements, demographic and medical history collection, intelligence test and symptom clinical scale assessments, and resting-state EEG collection. From the start of intervention until 4 weeks after completion, subjects will be followed up regarding clinical symptoms, neuroimaging, and adverse reactions.

The safety outcome: adverse events and their rate. The primary efficacy outcome is the change in Social Responsiveness Scale (SRS-2) scores 4 weeks after intervention completion compared to pre-intervention.

Secondary outcomes include changes in SRS-2 scores immediately after the 5-day intervention compared to pre-intervention; and changes in Chinese Communicative Development Inventory (CCDI), Childhood Autism Rating Scale (CARS), Peabody Picture Vocabulary Test (PPVT), Developmental Neuropsychological Assessment (NEPSY-II, including narrative memory, facial memory, theory of mind, vocabulary generation) four items, and Clinical Global Impression (CGI) scale scores 4 weeks after the 5-day intervention compared to pre-intervention.

Exploratory indicators include changes in resting-state EEG neuroimaging characteristics before intervention, immediately after the 5-day intervention, and 4 weeks after the 5-day intervention.

Conditions

Autism Spectrum Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Transcranial Alternating Current Stimulation

Intervention Type: 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;

Control group

Receive routine rehabilitation training during the study period

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: EXPERIMENTAL

transcranial Temporal Interference Stimulation

Intervention Type: 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;

Interventions

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;

Intervention Type: 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;

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Children aged 4-10 years

2. Meeting the diagnostic criteria for ASD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)

3. Diagnosis confirmed by the Autism Diagnostic Observation Schedule (ADOS) and/or the Autism Diagnostic Interview-Revised (ADI-R)

4. Full Scale Intelligence Quotient (FSIQ) ≥50

5. Signed informed consent form

Exclusion Criteria

1. Individuals with metal implants in the body

2. Individuals with neurological disorders such as epilepsy

3. Those requiring surgical treatment due to structural abnormalities indicated by brain MRI examination

4. Those diagnosed with genetic or chromosomal abnormalities

5. Individuals with mental illness (such as mood disorders, etc.)

6. Those with severe cardiac disease

7. Individuals with increased intracranial pressure

8. Those currently participating in other clinical trials

9. Those who received new intervention protocols within 4 weeks prior to enrollment.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fei Li

OTHER

Sponsor Role: lead

Responsible Party

Fei Li

Chief Physician, Doctoral Supervisor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

XHEC-C-2025-090-3

Identifier Type: -

Identifier Source: org_study_id