Feasibility and usability of remote transcranial direct current stimulation (tDCS) for self-regulation in children with autism: protocol for a randomized controlled pilot study.
Norna Abbo, Trina Mitchell, Seyed Hassan Tonekaboni, Evdokia Anagnostou, Brendan F Andrade, Kevin Thorpe, Deryk S Beal
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引用次数: 0
Abstract
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.
期刊介绍：
Pilot and Feasibility Studies encompasses all aspects of the design, conduct and reporting of pilot and feasibility studies in biomedicine. The journal publishes research articles that are intended to directly influence future clinical trials or large scale observational studies, as well as protocols, commentaries and methodology articles. The journal also ensures that the results of all well-conducted, peer-reviewed, pilot and feasibility studies are published, regardless of outcome or significance of findings. Pilot and feasibility studies are increasingly conducted prior to a full randomized controlled trial. However, these studies often lack clear objectives, many remain unpublished, and there is confusion over the meanings of the words “pilot” and “feasibility”. Pilot and Feasibility Studies provides a forum for discussion around this key aspect of the scientific process, and seeks to ensure that these studies are published, so as to complete the publication thread for clinical research.
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