Home-based Transcranial Direct Current Stimulation (tDCS) to Promote Social Communication and Behaviour in Children With Autism Spectrum Disorder (ASD)
- Conditions
- Autism Spectrum Disorder
- Interventions
- Device: At-home transcranial direct current stimulation (tDCS)Device: Sham at-home tDCS
- Registration Number
- NCT06129058
- Lead Sponsor
- Holland Bloorview Kids Rehabilitation Hospital
- 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..
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- Children with a diagnosis of autism spectrum disorder and self-regulation impairment or social communication challenges
- Able to participate in tDCS
- Children with contraindications to tDCS (history of seizures, family history of seizures, metal implants)
- Co-existing neurological conditions (epilepsy, stroke, etc.)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description tDCS At-home transcranial direct current stimulation (tDCS) active tDCS Sham Sham at-home tDCS sham tDCS
- Primary Outcome Measures
Name Time Method Recruitment weeks 1-18 Recruitment rates of 4 participants/month are achieved with a ≥ 20% response rate
Attrition weeks 1-18 Attrition rates of less than 10% (i.e., ≥90% of participants successfully complete assessments).
Blinding 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 weeks 1-18 90% of participants who complete assessment achieve the target intensity and dose (15 tDCS sessions)
- Secondary Outcome Measures
Name Time Method Inhibitory control 0 weeks, 6 weeks, 18 weeks change in Go/No Task Response Time
Overall Clinical Change 0 weeks, 6 weeks, 18 weeks Clinical Global Impression scale - 1 item on a scale from 0-7 (a change of 0.5 indicates a clinical impact of significance)
Magnetic Resonance Imaging (MRI) 0 weeks, 6 weeks, 18 weeks Diffusion imaging - change in fractional anisotropy, Resting State functional MRI change in Blood Oxygen Level Dependent (BOLD) signal
Trial Locations
- Locations (1)
Holland Bloorview Kids Rehabilitation Hosptail
🇨🇦Toronto, Ontario, Canada