Home-based Transcranial Direct Current Stimulation (tDCS) to Promote Social Communication and Behaviour in Children With Autism Spectrum Disorder (ASD)
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Autism Spectrum Disorder
- Sponsor
- Holland Bloorview Kids Rehabilitation Hospital
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Recruitment
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief 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..
Investigators
Eligibility Criteria
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.)
Outcomes
Primary Outcomes
Recruitment
Time Frame: weeks 1-18
Recruitment rates of 4 participants/month are achieved with a ≥ 20% response rate
Attrition
Time Frame: weeks 1-18
Attrition rates of less than 10% (i.e., ≥90% of participants successfully complete assessments).
Blinding
Time Frame: weeks 1-18
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)
Adherence
Time Frame: weeks 1-18
90% of participants who complete assessment achieve the target intensity and dose (15 tDCS sessions)
Secondary Outcomes
- Inhibitory control(0 weeks, 6 weeks, 18 weeks)
- Magnetic Resonance Imaging (MRI)(0 weeks, 6 weeks, 18 weeks)
- Overall Clinical Change(0 weeks, 6 weeks, 18 weeks)