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..
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
20
30 minutes session 5 days/week for 3 weeks.
30 minutes session 5 days/week for 3 weeks.
Holland Bloorview Kids Rehabilitation Hosptail
Toronto, Ontario, Canada
RECRUITINGRecruitment
Recruitment rates of 4 participants/month are achieved with a ≥ 20% response rate
Time frame: weeks 1-18
Attrition
Attrition rates of less than 10% (i.e., ≥90% of participants successfully complete assessments).
Time frame: weeks 1-18
Adherence
90% of participants who complete assessment achieve the target intensity and dose (15 tDCS sessions)
Time frame: 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)
Time frame: weeks 1-18
Magnetic Resonance Imaging (MRI)
Diffusion imaging - change in fractional anisotropy, Resting State functional MRI change in Blood Oxygen Level Dependent (BOLD) signal
Time frame: 0 weeks, 6 weeks, 18 weeks
Inhibitory control
change in Go/No Task Response Time
Time frame: 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)
Time frame: 0 weeks, 6 weeks, 18 weeks
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