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..
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.)
Parallel
At-home transcranial direct current stimulation (tDCS)
Device30 minutes session 5 days/week for 3 weeks.
Sham at-home tDCS
Device30 minutes session 5 days/week for 3 weeks.
Recruitment
Recruitment rates of 4 participants/month are achieved with a ≥ 20% response rate
Attrition
Attrition rates of less than 10% (i.e., ≥90% of participants successfully complete assessments).
Adherence
90% of participants who complete assessment achieve the target intensity and dose (15 tDCS sessions)
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)
Magnetic Resonance Imaging (MRI)
Diffusion imaging - change in fractional anisotropy, Resting State functional MRI change in Blood Oxygen Level Dependent (BOLD) signal
Inhibitory control
change in Go/No Task Response Time
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)
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