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

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..

Study Overview

• Status: Recruiting
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Device: At-home transcranial direct current stimulation (tDCS); Device: Sham at-home tDCS

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..

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Deryk Beal, PhD; Phone Number: 3582 416-425-6220; Email: dbeal@hollandbloorview.ca
• Study Contact Backup: Name: Trina Mitchell, PhD; Phone Number: 3965 416-425-6220; Email: tmitchell@hollandbloorview.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4G1R5
      • Recruiting
      • Holland Bloorview Kids Rehabilitation Hosptail
      • Contact: Deryk Beal, PhD; Phone Number: 3582 416-425-6220; Email: dbeal@hollandbloorview.ca
      • Contact: Trina Mitchell, PhD; Phone Number: 3965 416-425-6220; Email: tmichell@hollandbloorview.ca
      • Sub-Investigator: Evdokia Anagnostou, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham; sham tDCS	Device: Sham at-home tDCS; 30 minutes session 5 days/week for 3 weeks.
Experimental: tDCS; active tDCS	Device: At-home transcranial direct current stimulation (tDCS); 30 minutes session 5 days/week for 3 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment	Recruitment rates of 4 participants/month are achieved with a ≥ 20% response rate	weeks 1-18
Attrition	Attrition rates of less than 10% (i.e., ≥90% of participants successfully complete assessments).	weeks 1-18
Adherence	90% of participants who complete assessment achieve the target intensity and dose (15 tDCS sessions)	weeks 1-18
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Inhibitory control	change in Go/No Task Response Time	0 weeks, 6 weeks, 18 weeks
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

Collaborators and Investigators

• Sponsor: Holland Bloorview Kids Rehabilitation Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2023
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: November 8, 2023
• First Submitted That Met QC Criteria: November 8, 2023
• First Posted (Actual): November 13, 2023

Study Record Updates

• Last Update Posted (Estimated): January 1, 2024
• Last Update Submitted That Met QC Criteria: December 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: MRI; tDCS; brain stimulation
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
• Other Study ID Numbers: ASDR02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No