# Feasibility and usability of remote transcranial direct current stimulation (tDCS) for self-regulation in children with autism: protocol for a randomized controlled pilot study

## TL;DR

This study tests if home-based tDCS can help children with autism improve self-regulation, with virtual support and assessments over time.

## Contribution

The study introduces a protocol for evaluating remote tDCS feasibility and usability for self-regulation in children with ASD.

## Key findings

- The protocol assesses recruitment, retention, and adherence rates to determine feasibility.
- Usability is evaluated through surveys, interviews, and video analysis of device use.
- Assessments include clinical measures, response inhibition tasks, and MRI scans.

## Abstract

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.

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.

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.

ClinicalTrials.gov, NCT06129058. Registered on November 8, 2024.

The online version contains supplementary material available at 10.1186/s40814-025-01650-4.