Autism Spectrum DisorderNCT07045584
Temporal Pole Transcranial Alternating Current Stimulation for Children With Autism Spectrum Disorder
A study testing Transcranial Alternating Current Stimulation and transcranial Temporal Interference Stimulation in people with Autism Spectrum Disorder, run by Fei Li at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Transcranial Alternating Current Stimulation and transcranial Temporal Interference Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 7 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Individuals with increased intracranial pressure
- Those currently participating in other clinical trials
- Those who received new intervention protocols within 4 weeks prior to enrollment.
Trial locations and contacts
1 site in 1 country.
China1 site
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200000
About this study
Official title: Temporal Pole Transcranial Alternating Current Stimulation for Children With Autism Spectrum Disorder: A Randomized Controlled Open-Label Trial
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?
Read more
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
Read the 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
- Being tested
- Transcranial Alternating Current Stimulation, transcranial Temporal Interference Stimulation
- Keywords
- Autism Spectrum Disorder (ASD), Transcranial Alternating Current Stimulation (tACS), Transcranial temporal interference stimulation (tTIS), Children, Intervention
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Alternating Current StimulationDevice
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;
transcranial Temporal Interference StimulationDevice
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;
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: transcranial Temporal Interference Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 4 weeks after completion of 5-day intervention
Secondary outcomes (7)
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.
Measured: Baseline, after completion of 5-day intervention
Childhood Autism Rating Scale (CARS)
CARS is a behavior rating scale used to assess the presence and severity of the symptoms associated autism spectrum disorder. The scores of the CARS rate from 15 to 60, and higher scores indicate more severe symptoms. The changes in the CAR scores from baseline to 3 months after the treatment will be analyzed to asses the impact often intervention on participants with ASD.
Measured: Baseline, 4 weeks after completion of 5-day intervention
Chinese Communicative Development Inventory, CCDI
Chinese Communicative Development Inventory(CCDl)is a questionnaire used to measures the language abilities. Higher scores suggest better language level. The changes in the CCDl between baseline and 3 month after treatment will be analyzed.
Measured: Baseline, 4 weeks after completion of 5-day intervention
Peabody Picture Vocabulory Test, PPVT
PPVT as a tool for measuring children's language receptive ability and language comprehension ability
Measured: Baseline, 4 weeks after completion of 5-day intervention
Neuropsychological Assessment for Child, NEPSY-II
NEPSY-II is a comprehensive neuropsychological measurement tool used for assessing neuro-cognitive functions in children aged 3-16 years. This study primarily evaluates four aspects: narrative memory assessment; facial memory assessment; theory of mind; and word generation.
Measured: Baseline, 4 weeks after completion of 5-day intervention
Vineland Adaptive Behavior Scales-Third Edition, Vineland-3
The VABS-3 is used to measure adaptive functioning across domains such as communication,daily living skills,socialization,and motor skills.Changes in VABs scores from baseline to 3 months post-treatment will be analyzed to assess the intervention's impact on adaptive behaviors in children with ASD.
Measured: Baseline, 4 weeks after completion of 5-day intervention
Clinical Global Impression Scale (CGI)
The Clinical Global Impressions (CGI) scale is used to assess both the severity of illness and the global improvement of participants undergoing intervention.The Clinical Global Impression-Severity scale (CGI-S) is a clinician-rated, 7-point scale that measures overall illness severity. Scores range from 1 (Normal, not at all ill) through 4 (Moderately ill) to 7 (Among the most extremely ill patients).
The Clinical Global Impression-Improvement scale (CGI-I) is a companion measure that evaluates changes in the patient's symptoms relative to baseline. Scores range from 1 (Very much improved) through 4 (No change) to 7 (Very much worse).The CGI-E thus yields an efficacy index (EI) that reflects the net clinical benefit, accounting for both symptom improvement and adverse effects.
Measured: after completion of 5-day intervention, four weeks after completion of 5-day intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start1 Jul 2025
- Primary completion30 Sep 2025
- Study completion7 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fei Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fei Li, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07045584
- Sponsor's protocol ID
- XHEC-C-2025-090-3
- Status last verified
- Mar 2026
- First submitted
- 29 May 2025
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study Protocol, statisticalAnalysis plan, informed Consent Form, and other relevant documents wil be available under reasonable and ethically approved request to the corresponding authors.
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temporal Pole Transcranial Alternating Current Stimulation for Children With Autism Spectrum Disorder: A Randomized Controlled Open-Label Trial
- ClinicalTrials.gov ID
- NCT07045584
- Acronym / sponsor ID
- XHEC-C-2025-090-3
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism Spectrum Disorder (ASD), Transcranial Alternating Current Stimulation (tACS), Transcranial temporal interference stimulation (tTIS), Children, Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Fei LiUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 7 Oct 2025 (actual)
- First posted
- 1 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention group(tACS) | Experimental | Device: Transcranial Alternating Current StimulationReceive 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 | No intervention | –Receive routine rehabilitation training during the study period |
| Intervention group(tTIS) | Experimental | Device: transcranial Temporal Interference StimulationReceive 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 |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Alternating Current StimulationIntervention 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 | Intervention group(tACS) |
| transcranial Temporal Interference StimulationIntervention 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; | Device | Intervention group(tTIS) |
Primary outcome
Social Responsiveness Scale, SRS-2
Time frame: Baseline, 4 weeks after completion of 5-day intervention
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.
7 secondary outcomes
SRS-2
Time frame: Baseline, after completion of 5-day intervention
Childhood Autism Rating Scale (CARS)
Time frame: Baseline, 4 weeks after completion of 5-day intervention
Chinese Communicative Development Inventory, CCDI
Time frame: Baseline, 4 weeks after completion of 5-day intervention
Peabody Picture Vocabulory Test, PPVT
Time frame: Baseline, 4 weeks after completion of 5-day intervention
Neuropsychological Assessment for Child, NEPSY-II
Time frame: Baseline, 4 weeks after completion of 5-day intervention
Vineland Adaptive Behavior Scales-Third Edition, Vineland-3
Time frame: Baseline, 4 weeks after completion of 5-day intervention
Clinical Global Impression Scale (CGI)
Time frame: after completion of 5-day intervention, four weeks after completion of 5-day intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Individual participant dataSharing planned: No. The study Protocol, statisticalAnalysis plan, informed Consent Form, and other relevant documents wil be available under reasonable and ethically approved request to the corresponding authors.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Alternating Current Stimulation and transcranial Temporal Interference Stimulation in people with Autism Spectrum Disorder, run by Fei Li at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social Responsiveness Scale, SRS-2 (time frame: Baseline, 4 weeks after completion of 5-day intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.