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. 2024 Feb 5:15:1337101.
doi: 10.3389/fpsyt.2024.1337101. eCollection 2024.

Effects of transcutaneous auricular vagus nerve stimulation and exploration of brain network mechanisms in children with high-functioning autism spectrum disorder: study protocol for a randomized controlled trial

Ke Sun  1 , Ying Li  2 , Zhenhang Zhai  1 , Heqing Yin  1 , Shuli Liang  1 , Feng Zhai  1 , Yonghua Cui  2 , Guojun Zhang  1
Affiliations

Effects of transcutaneous auricular vagus nerve stimulation and exploration of brain network mechanisms in children with high-functioning autism spectrum disorder: study protocol for a randomized controlled trial

Ke Sun et al. Front Psychiatry. .

Abstract

Background: Autism Spectrum Disorders (ASD) are a collection of neurodevelopmental diseases characterized by poor social interaction and communication, a limited range of interests, and stereotyped behavior. High-functioning autism (HFA) indicates a subgroup of individuals with autism who possess cognitive and/or language skills that are within the average to above-normal range for their age. Transcutaneous auricular vagus nerve stimulation (taVNS) holds promise in children with HFA. However, few studies have used randomized controlled trials to validate the effectiveness of taVNS. Therefore, in this study, we intend to provide a study protocol to examine the therapeutic effects of taVNS in individuals diagnosed with HFA and to investigate the process of brain network remodeling in individuals with ASD using functional imaging techniques to observe alterations in large-scale neural networks.

Methods and design: We planned to employ a randomized, double-blind experimental design, including 40 children receiving sham stimulation and 40 children receiving real stimulation. We will assess clinical scales and perform functional imaging examinations before and after the stimulation. Additionally, we will include age- and gender-matched healthy children as controls and conduct functional imaging examinations. We plan first to observe the therapeutic effects of taVNS. Furthermore, we will observe the impact of taVNS stimulation on the brain network.

Discussion: taVNS was a low-risk, easy-to-administer, low-cost, and portable option to modulate the vagus system. taVNS may improve the social performance of HFA. Changes in the network properties of the large-scale brain network may be related to the efficacy of taVNS.

Clinical trial registration: http://www.chictr.org.cn, identifier ChiCTR2300074035.

Keywords: high-functioning autism; neuromodulation; protocol; randomized control trial; transcutaneous auricular vagus nerve stimulation.

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Conflict of interest statement

The authors declare that the research was conducted without any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
A schematic representation of the study timeline of events.
Figure 2
Figure 2
Proposed study procedures and participant flow. HFA, high−functioning autism spectrum disorder; ABC, Autism Behavior Scale; CABS, Clancy Autism Behavioral Scale; SRS, Social Responsiveness Scale; HC, healthy controls; fMRI 、DTI.
See this image and copyright information in PMC

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