Home-based Transcranial Direct Current Stimulation (tDCS) to Promote Social Communication and Behaviour in Children With Autism Spectrum Disorder (ASD)

Last updated: July 29, 2024
Sponsor: Holland Bloorview Kids Rehabilitation Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

Autism

Asperger's Disorder

Autism Spectrum Disorder (Asd)

Treatment

Sham at-home tDCS

At-home transcranial direct current stimulation (tDCS)

Clinical Study ID

NCT06129058
ASDR02
  • Ages 9-18
  • All Genders

Study Summary

Transcranial direct current stimulation (tDCS) is a form of non-invasive brain stimulation that can be delivered in a home setting. It is a safe and tolerable intervention that has shown promise for improving positive social communication and self-regulation in youth with Autism Spectrum Disorder (ASD). Children and youth with ASD will be randomized to At-home tDCS or sham control stimulation for 3 weeks. We will measure the effect of At-home tDCS on the brain mechanisms and clinical measures of social communication and self-regulation..

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Children with a diagnosis of autism spectrum disorder and self-regulation impairmentor social communication challenges

  • Able to participate in tDCS

Exclusion

Exclusion Criteria:

  • Children with contraindications to tDCS (history of seizures, family history ofseizures, metal implants)

  • Co-existing neurological conditions (epilepsy, stroke, etc.)

Study Design

Total Participants: 20
Treatment Group(s): 2
Primary Treatment: Sham at-home tDCS
Phase: 2
Study Start date:
October 20, 2023
Estimated Completion Date:
September 30, 2025

Study Description

Transcranial direct current stimulation (tDCS) is a form of non-invasive brain stimulation that can be delivered in a home setting. It is a safe and tolerable intervention that has shown promise for improving positive social communication and self-regulation in youth with Autism Spectrum Disorder (ASD). Previous studies have been limited by small and poorly represented samples, lack of experimental control, insufficient follow-up periods, inadequate blinding and the absence of neural outcome measures. Our project will collect pilot data on the effects of home-based tDCS on reducing disruptive behaviours in youth with ASD, in order to inform the design of a follow-up full-scale clinical trial. We will recruit youth with ASD who experience clinically significant difficulties with social communication and self-regulation. Participants will be randomized to tDCS or sham control stimulation for 3 weeks. We will measure the effect of tDCS on the brain mechanisms and clinical measures of social communication and self-regulation..

Connect with a study center

  • Holland Bloorview Kids Rehabilitation Hosptail

    Toronto, Ontario M4G1R5
    Canada

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.