JMIR Publications

ABSTRACT

Background:

Autism spectrum disorder (ASD) is a neurodevelopmental disorder characterized by limited and repetitive behaviors and disturbances in social communication and interactions. Currently, there is no fundamental treatment for ASD, with only a few medications available for use on a limited basis to manage concomitant neuropsychiatric symptoms. The primary therapeutic goal of such treatments is to alleviate symptoms while maximizing the functional independence and quality of life of affected individuals. Many complementary and alternative medicine (CAM) therapies have been reported to have effects on ASD symptoms; however, evidence is insufficient to confirm their clinical effectiveness. Acupuncture has traditionally been used as a complementary intervention to manage various neurological and neuropsychiatric diseases, including ASD, in East Asia. However, how acupuncture stimulation modulates neural activity at the macroscale level in individuals with ASD remains largely unknown.

Objective:

This study aims to elucidate the acute neural mechanisms underlying acupuncture stimulation in patients with autism spectrum disorder (ASD) and typically developing individuals using a multimodal neuroimaging approach.

Methods:

This study was designed as a randomized placebo-controlled trial. Seventy participants, including individuals with ASD (n=35) and typically developing (TD) controls (n=35), will be randomly assigned to either the verum or sham acupuncture group. The verum acupuncture group will receive stimulation at specific acupoints clinically indicated for ASD and gain a deqi sensation. The sham acupuncture group will receive superficial needling at non-acupoints unrelated to the ASD symptoms. Each group will undergo clinical assessments and multimodal neuroimaging measurements, including functional near-infrared spectroscopy (fNIRS) and electroencephalography (EEG), before and after acupuncture stimulation. The primary outcomes include differences in resting brain connectivity, network metrics, and power spectrum densities associated with disease status, as well as changes in these neural markers following acupuncture stimulation between the two groups. Secondary outcomes will focus on identifying neural markers and specific brain regions that correlate with clinical indicators of autism spectrum disorder.

Results:

Recruitment began in April 2025. To date, 20 ASD and 12 TD individuals have participated in this study. The recruitment process is expected to continue until December 2026.

Conclusions:

ASD presents a significant socioeconomic burden, with no definitive treatment established to date. Although acupuncture is a widely applied intervention for various neurological conditions, including ASD, its macroscale neural mechanisms remain poorly understood. By employing multimodal neuroimaging, the present study aims to elucidate the immediate neural substrates underlying acupuncture stimulation in patients with ASD. These findings should provide a robust neurobiological foundation for future longitudinal research and development of evidence-based integrative treatment strategies. Clinical Trial: Clinical Research Information Service of the Republic of Korea (CRIS), one of the WHO ICTRP Primary Registries; KCT0010437 (https://cris.nih.go.kr/cris/search/detailSearch.do/31192)