远程经颅直流电刺激（tDCS）用于自闭症儿童自我调节的可行性和可用性：一项随机对照试验研究方案
Feasibility and usability of remote transcranial direct current stimulation (tDCS) for self-regulation in children with autism: protocol for a randomized controlled pilot study.
作者信息
Abbo Norna, Mitchell Trina, Tonekaboni Seyed Hassan, Anagnostou Evdokia, Andrade Brendan F, Thorpe Kevin, Beal Deryk S
机构信息
Bloorview Research Institute, Holland Bloorview Kids Rehabilitation, Toronto, Canada.
Institute of Biomedical Engineering, University of Toronto, Toronto, Canada.
出版信息
Pilot Feasibility Stud. 2025 Apr 29;11(1):57. doi: 10.1186/s40814-025-01650-4.
BACKGROUND
Autism spectrum disorder (ASD) is a neurodevelopmental disorder characterized by social communication and self-regulation impairments. Impaired response inhibition and self-regulation in ASD have been shown to be related to abnormal functional network connectivity in the dorsolateral prefrontal cortices (DLPFC). Transcranial direct current stimulation (tDCS) of DLPFC is a safe, tolerable, and precise intervention that has shown promise for the improvement of self-regulatory behavior in ASD. However, clinical translation has been prevented by a lack of effective systematic design, experimental control, and a high participation burden. The proposed protocol aims to evaluate the feasibility and usability of home-based tDCS to promote self-regulation in children with ASD.
METHODS
Participants will be randomized into an active or sham tDCS group and will receive 20 min of stimulation 5 days per week for 3 weeks. Participants in the sham group receive a negligible amount of stimulation. Sessions will be virtually supported by the study team. Assessments are taken at baseline, 1-week post-treatment, and 18 weeks post-treatment. These assessments include clinical measures of self-regulation and social communication (participant-, parent-, and clinician-reported), a response inhibition task, and magnetic resonance imaging. Recruitment, retention, and adherence rates will be used to assess the feasibility of the protocol. The usability of the remote tDCS device will be assessed via a usability survey, user interviews, and video analysis of device use.
DISCUSSION
Home-based tDCS may benefit children by providing an efficient, passive, and tolerable treatment that positively impacts function, activities, and participation. This study will identify potential challenges for the clinical translation of this therapy so that home-based tDCS can be positioned for success in healthcare delivery implementation.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT06129058. Registered on November 8, 2024.
背景
自闭症谱系障碍（ASD）是一种神经发育障碍，其特征为社交沟通和自我调节受损。研究表明，ASD患者的反应抑制和自我调节受损与背外侧前额叶皮质（DLPFC）的功能网络连接异常有关。对DLPFC进行经颅直流电刺激（tDCS）是一种安全、可耐受且精确的干预措施，已显示出改善ASD患者自我调节行为的潜力。然而，由于缺乏有效的系统设计、实验控制以及较高的参与负担，该疗法尚未实现临床转化。本研究方案旨在评估家庭式tDCS促进ASD儿童自我调节的可行性和可用性。
方法
参与者将被随机分为主动tDCS组或假刺激tDCS组，每周5天，每天接受20分钟刺激，持续3周。假刺激组参与者接受的刺激量可忽略不计。治疗过程将由研究团队提供虚拟支持。在基线、治疗后1周和治疗后18周进行评估。这些评估包括自我调节和社交沟通的临床指标（参与者、家长和临床医生报告）、反应抑制任务以及磁共振成像。将通过招募率、留存率和依从率评估方案的可行性。将通过可用性调查、用户访谈以及设备使用视频分析评估远程tDCS设备的可用性。
讨论
家庭式tDCS可能通过提供一种高效、被动且可耐受的治疗方法，对儿童的功能、活动和参与产生积极影响。本研究将确定该疗法临床转化的潜在挑战，以便家庭式tDCS能够在医疗保健实施中取得成功。
试验注册
ClinicalTrials.gov，NCT06129058。于2024年11月8日注册。
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