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Brain Stimulation Through the Scalp for Children With Autism: A Safety Study

Tests whether temporal interference brain stimulation is safe and workable in children with autism.

Key facts

Who runs it
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Where
Shanghai, ChinaSee the site
Trial code
Registry title
Transcranial Temporal Interference Stimulation for Children With Autism Spectrum Disorders
Status
Recruiting
People taking part
16 people, planned
Started
25 May 2026
Planned end
5 Oct 2026
Type of study
Interventional, 2 groupsOne group gets a sham (pretend) treatment, for comparison.
Treatments tested
  • transcranial Temporal Interference Stimulation
Record updated
4 June 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children aged 4-10 years with autism spectrum disorder. It tests whether a gentle brain stimulation (tTIS) is safe and workable.

Age
4 to 10 years
Sex
Girls and boys can both join.
Disease stage
Autism spectrum disorder confirmed by DSM-5 criteria and by the ADOS and/or ADI-R tests. Full Scale Intelligence Quotient (FSIQ) of 50 or more.
Earlier treatment
Cannot have started a new intervention protocol within 4 weeks before joining.

Main reasons for not taking part

  • Metal implants in the body
  • Neurological disorders such as epilepsy
  • Genetic or chromosomal abnormalities
  • Mental illness such as early-onset schizophrenia
  • Severe heart disease

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Individuals with metal implants in the body
  • Those requiring surgical treatment due to structural abnormalities indicated by brain MRI examination
  • Those who received new intervention protocols within 4 weeks prior to enrollment
  • Individuals with neurological disorders such as epilepsy
  • Individuals with mental illness (such as early-onset schizophrenia)
  • Those with severe cardiac disease
  • Those diagnosed with genetic or chromosomal abnormalities
  • Individuals with increased intracranial pressure
  • Those currently participating in other clinical trials

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 4 and 10 years old?

Where in China

  • Fei LiShanghai, ChinaContact: Fei Li, PHD, MDTaking people

About the trial

What the trial wants to find out

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:

Read full original descriptionShow less

- 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.

The 2 groups in the trial

  • Intervention group (tTIS)Treatment being tested

    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

    Treatment: transcranial Temporal Interference Stimulation

  • Control groupSham treatment, for comparison

    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

    Treatment: transcranial Temporal Interference Stimulation

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Individualized Targeted Transcranial Temporal Interference Stimulation for Children With Autism Spectrum Disorder: A Single-Blinded, Randomized, Controlled Exploratory Trial
Plain-language title
Brain Stimulation Through the Scalp for Children With Autism: A Safety StudyGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07625748, who can take part
Record updated
4 June 2026