Individualized Targeted Transcranial Temporal Interference Stimulation for Children With Autism Spectrum Disorder: A Single-Blinded, Randomized, Controlled Exploratory Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 16
- Locations
- 1
Study Overview
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.
Detailed Description
This research is a 5-week single-blinded, randomized controlled trial, planning to enroll 16 ASD 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 two groups: tTIS group and sham group. The tTIS group will undergo 5 days of temporal TI stimulation (1.5mA, 2040/2000Hz, 20min/session, 6 sessions/day); the control group will undergo 5 days of temporal TI stimulation (1.5mA, 2000/2000Hz, 20min/session, 6 sessions/day, without 40Hz envelope compared to tTIS group)
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 events.
Primary Outcome Measures:
- Safety and feasibility of tTIS, assessed by adverse events, treatment completion rate, adherence to the stimulation protocol and tolerability.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Device Feasibility
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 4 Years to 10 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Investigators
Fei Li
Chief Physician
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine