NCT06129058

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Holland Bloorview Kids Rehabilitation Hospital · Academic / Other
• Sex: All
• Age: 9 Years – 18 Years
• Healthy volunteers: Not accepted

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..

Detailed 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..

Conditions

• Autism Spectrum Disorder

Interventions

Type	Name	Description
DEVICE	At-home transcranial direct current stimulation (tDCS)	30 minutes session 5 days/week for 3 weeks.
DEVICE	Sham at-home tDCS	30 minutes session 5 days/week for 3 weeks.

Timeline

• Start date: 2023-10-20
• Primary completion: 2025-09-30
• Completion: 2025-09-30
• First posted: 2023-11-13
• Last updated: 2024-07-30

Locations

1 site across 1 country: Canada