JMIR Publications

ABSTRACT

Background:

Autism spectrum disorder (ASD) represents a significant public health challenge characterized by persistent social communication deficits and restricted, repetitive patterns of behavior. Current interventions show limited efficacy, particularly for core symptoms. Repetitive transcranial magnetic stimulation (rTMS) and auditory integration training (AIT) have independently demonstrated promise in addressing neurophysiological abnormalities associated with ASD. This study aims to evaluate the clinical efficacy of dual-modality intervention with a combination of TMS and AIT compared to rTMS alone and sham stimulation for children with ASD.

Methods:

This randomized sham-controlled trial will recruit 60 children aged 2-6 years with confirmed ASD diagnosis. Participants will be randomly allocated in a 1:1:1 ratio to receive: (1) active rTMS (n=20), (2) active rTMS plus AIT (n=20), or (3) sham rTMS (n=20). Primary outcome measures include changes in Autism Behavior Checklist (ABC) and Childhood Autism Rating Scale (CARS) scores. Secondary outcomes include the Strengths and Difficulties Questionnaire (SDQ) and Repetitive Behavior Scale-Revised (RBS-R). Assessments will be conducted at baseline and immediately post-intervention. SPSS software was used for data processing and analysis. Discussion: This study will be the first sham-controlled trial to systematically investigate the potential synergistic effects of combined rTMS and AIT intervention in children with ASD. Results will provide valuable insights into the neurotherapeutic potential of this combined approach and contribute to the development of evidence-based interventions for ASD. Trial registration: Chinese Clinical Trials Registry: ChiCTR2400082706. (URL:http://www.chictr.org.cn/showproj). Registered on April 3, 2024.