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

Study Overview
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Brief Summary
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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
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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..

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

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Device: At-home transcranial direct current stimulation (tDCS)
* Device: Sham at-home tDCS


Participation Criteria
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Eligibility Criteria
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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.)

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized sham-controlled
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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 members will be assessed using a Blinding Questionnaire indicating the perceived group membership | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tDCS, MRI, brain stimulation