Transcranial Temporal Interference Stimulation for Children With Autism Spectrum Disorders

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-10
SponsorXinhua Hospital, Shanghai Jiao Tong University School of Medicine

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • transcranial Temporal Interference Stimulation

Treatment groups

16 Participants
are divided into 2 treatment groups