Scalp acupuncture for children with autism spectrum disorder: Protocol for a randomized controlled trial using EEG and structural MRI to assess multimodal neurofunctional changes

Introduction Autism spectrum disorder (ASD) is a neurodevelopmental condition characterized by deficits in social communication and restricted behaviors. Scalp acupuncture may improve ASD symptoms. However, high-quality clinical evidence and mechanistic insights are limited. This trial aims to rigorously assess the clinical efficacy and neurophysiological mechanisms of scalp acupuncture for ASD using behavioral evaluations and multimodal neuroimaging (EEG and sMRI). Methods and analysis This single-center, parallel-group, assessor-blinded, randomized controlled trial will enroll 120 children with ASD aged 2-6 years. Participants will be allocated (1:1) to scalp acupuncture plus educational rehabilitation or rehabilitation alone for 12 weeks (six sessions/week). The primary outcomes will be changes in the Autism Treatment Evaluation Checklist (ATEC) and Childhood Autism Rating Scale (CARS) scores from baseline to week 12. Secondary outcomes will include the Autism Behavior Checklist (ABC), Psychoeducational Profile-3 (PEP-3), and caregiver satisfaction. Resting-state electroencephalography (EEG) and sMRI data will be collected at baseline and week 12 to assess brain network and structural changes. Adverse events will be monitored throughout the study period. Ethics and dissemination The study protocol has been approved by the Institutional Ethics Committee of the Institute of Basic Clinical Medicine, China Academy of Chinese Medical Sciences (Approval No. P25009-PJ09). Written informed consent will be obtained from the legal guardians of all participants prior to enrollment. Results will be disseminated through peer-reviewed scientific journals and academic conferences. Trial registration number ITMCTR2025001437.