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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..
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tDCS | Experimental | active tDCS |
|
| Sham | Sham Comparator | sham tDCS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| At-home transcranial direct current stimulation (tDCS) | Device | 30 minutes session 5 days/week for 3 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment | Recruitment rates of 4 participants/month are achieved with a ≥ 20% response rate | weeks 1-18 |
| Attrition | Attrition rates of less than 10% (i.e., ≥90% of participants successfully complete assessments). | weeks 1-18 |
| Adherence | 90% of participants who complete assessment achieve the target intensity and dose (15 tDCS sessions) | 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) | weeks 1-18 |
| Measure | Description | Time Frame |
|---|---|---|
| Magnetic Resonance Imaging (MRI) | Diffusion imaging - change in fractional anisotropy, Resting State functional MRI change in Blood Oxygen Level Dependent (BOLD) signal | 0 weeks, 6 weeks, 18 weeks |
| Inhibitory control |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Deryk Beal, PhD | Contact | 416-425-6220 | 3582 | dbeal@hollandbloorview.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Holland Bloorview Kids Rehabilitation Hosptail | Recruiting | Toronto | Ontario | M4G1R5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40301914 | Derived | Abbo N, Mitchell T, Tonekaboni SH, Anagnostou E, Andrade BF, Thorpe K, Beal DS. Feasibility and usability of remote transcranial direct current stimulation (tDCS) for self-regulation in children with autism: protocol for a randomized controlled pilot study. Pilot Feasibility Stud. 2025 Apr 29;11(1):57. doi: 10.1186/s40814-025-01650-4. |
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Randomized sham-controlled
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Participants and outcomes assessor will be blind to tDCS or sham condition.
| Sham at-home tDCS | Device | 30 minutes session 5 days/week for 3 weeks. |
|
change in Go/No Task Response Time
| 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) | 0 weeks, 6 weeks, 18 weeks |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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