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Transcranial Temporal Interference Stimulation for Children With Autism Spectrum Disorders

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated June 4, 2026 (before its estimated September 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT07625748
Lead Sponsor Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Conditions
(from sponsor)		 Autism Spectrum Disorder
Related terms Autism Spectrum Disorder
Enrollment 16 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov