Transcranial Temporal Interference Stimulation for Children With Autism Spectrum Disorders
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: transcranial Temporal Interference Stimulation.
- Who it may be relevant to
- Registry conditions: Autism Spectrum Disorder. Basic parameters: 4 years — 10 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Individualized Targeted Transcranial Temporal Interference Stimulation for Children With Autism Spectrum Disorder: A Single-Blinded, Randomized, Controlled Exploratory Trial
Overview
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.
Secondary outcomes:
* Change in Social Responsiveness Scale, Second Edition (SRS-2) total score from baseline to immediately after completion of the 5-day intervention. * Change in SRS-2 total score from baseline to 4 weeks after completion of the 5-day intervention. * Changes in other clinical measures from baseline to 4 weeks after completion of the 5-day intervention, including the Chinese Communicative Development Inventory (CCDI), Childhood Autism Rating Scale (CARS), Peabody Picture Vocabulary Test (PPVT), selected subtests of A Developmental Neuropsychological Assessment, Second Edition (NEPSY-II; Narrative Memory, Memory for Faces, Theory of Mind, Word Generation, and Affect Recognition), and Clinical Global Impression (CGI) scale scores.
Exploratory Outcomes:
\- resting-state and task-state EEG neuroimaging characteristics before intervention, immediately after the 5-day intervention, and 4 weeks after completion of the 5-day intervention
Interventions
- Device transcranial Temporal Interference Stimulation
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.
Primary outcome measures
- Completion of the tTIS intervention protocol [Time frame: During the 5-day intervention]
- Number of participants with adverse events [Time frame: From the start of the intervention to 4 weeks after completion of the 5-day intervention.]
Secondary outcome measures (9)
- 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]
- Social Responsiveness Scale, Second Edition (SRS-2) [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]
- Multilingual Assessment Instrument for Narratives (MAIN) [Time frame: Baseline, 4 weeks after completion of 5-day intervention]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Device feasibility
Study locations
China · 1 center
- Fei Li — Shanghai
Identifiers
NCT: NCT07625748 · XHEC-C-2026-109-1