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

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06129058
• Other study ID #: ASDR02
• Status: Recruiting
• Phase: Phase 2
• Start date: October 20, 2023
• Est. completion date: September 30, 2025

Study information

• Verified date: November 2023
• Source: Holland Bloorview Kids Rehabilitation Hospital
• Contact: Trina Mitchell, PhD
• Phone: 416-425-6220
• Email: tmitchell[@]hollandbloorview.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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..

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..

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 18 Years

Eligibility

Inclusion Criteria:

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

• Able to participate in tDCS

Exclusion Criteria:

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

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

Device:
• At-home transcranial direct current stimulation (tDCS)
30 minutes session 5 days/week for 3 weeks.
• Sham at-home tDCS
30 minutes session 5 days/week for 3 weeks.

Locations

Country	Name	City	State
Canada	Holland Bloorview Kids Rehabilitation Hosptail	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Holland Bloorview Kids Rehabilitation Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment	Recruitment rates of 4 participants/month are achieved with a = 20% response rate	weeks 1-18
Primary	Attrition	Attrition rates of less than 10% (i.e., =90% of participants successfully complete assessments).	weeks 1-18
Primary	Adherence	90% of participants who complete assessment achieve the target intensity and dose (15 tDCS sessions)	weeks 1-18
Primary	Blinding	Blinding of participants and their parents/caregivers and required study team using a Blinding Questionnaire indicating the perceived group membershipmembers will be assessed using a Blinding Questionnaire indicating the perceived group membership (tDCS/Sham)	weeks 1-18
Secondary	Magnetic Resonance Imaging (MRI)	Diffusion imaging - change in fractional anisotropy, Resting State functional MRI change in Blood Oxygen Level Dependent (BOLD) signal	0 weeks, 6 weeks, 18 weeks
Secondary	Inhibitory control	change in Go/No Task Response Time	0 weeks, 6 weeks, 18 weeks
Secondary	Overall Clinical Change	Clinical Global Impression scale - 1 item on a scale from 0-7 (a change of 0.5 indicates a clinical impact of significance)	0 weeks, 6 weeks, 18 weeks