Holland Bloorview Kids Rehabilitation Hosptail
Toronto, Ontario, M4G1R5, Canada
Location status: Recruiting
NCT Number: NCT06129058
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..
Interested in participating?
Request Info9 year–18 year
All sexes
Interventional
Phase 2
Toronto, Ontario, M4G1R5, Canada
Location status: Recruiting
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..
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
30 minutes session 5 days/week for 3 weeks.
30 minutes session 5 days/week for 3 weeks.
Time frame: weeks 1-18
Recruitment rates of 4 participants/month are achieved with a ≥ 20% response rate
Time frame: weeks 1-18
Attrition rates of less than 10% (i.e., ≥90% of participants successfully complete assessments).
Time frame: weeks 1-18
90% of participants who complete assessment achieve the target intensity and dose (15 tDCS sessions)
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)
Time frame: 0 weeks, 6 weeks, 18 weeks
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
change in Go/No Task Response Time
Time frame: 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)
Contact information is provided by the study sponsor or research team.
Holland Bloorview Kids Rehabilitation Hospital
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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