Transcranial Temporal Interference Stimulation for Children With Autism Spectrum Disorders

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

• SRS-2 [Срок оценки: Baseline, after completion of 5-day intervention]
• Childhood Autism Rating Scale (CARS) [Срок оценки: Baseline, 4 weeks after completion of 5-day intervention]
• Social Responsiveness Scale, Second Edition (SRS-2) [Срок оценки: Baseline, 4 weeks after completion of 5-day intervention]
• Chinese Communicative Development Inventory, CCDI [Срок оценки: Baseline, 4 weeks after completion of 5-day intervention]
• Peabody Picture Vocabulory Test, PPVT [Срок оценки: Baseline, 4 weeks after completion of 5-day intervention]
• Neuropsychological Assessment for Child, NEPSY-II [Срок оценки: Baseline, 4 weeks after completion of 5-day intervention]
• Vineland Adaptive Behavior Scales-Third Edition, Vineland-3 [Срок оценки: Baseline, 4 weeks after completion of 5-day intervention]
• Clinical Global Impression Scale (CGI) [Срок оценки: after completion of 5-day intervention, four weeks after completion of 5-day intervention]
• Multilingual Assessment Instrument for Narratives (MAIN) [Срок оценки: Baseline, 4 weeks after completion of 5-day intervention]