Clinical Research Directory

Transcranial Temporal Interference Stimulation for Children With Autism Spectrum Disorders

Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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.

Official title: Individualized Targeted Transcranial Temporal Interference Stimulation for Children With Autism Spectrum Disorder: A Single-Blinded, Randomized, Controlled Exploratory Trial

Key Details

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Interventions

Locations (1)