A Phase 2 interventional study of At-home transcranial direct current stimulation (tDCS) and Sham at-home tDCS in Autism Spectrum Disorder, sponsored by Holland Bloorview Kids Rehabilitation Hospital. Recruiting at 1 site in Canada. Open to participants aged 9 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-07-30.
Sponsored by Holland Bloorview Kids Rehabilitation Hospital · Phase 2, Interventional, and Treatment
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Among 22 studies in Autism Spectrum Disorder by Holland Bloorview Kids Rehabilitation Hospital — 5 open to participants now, 6 under way, none of them phase 3. Autism Spectrum Disorder · Holland Bloorview Kids Rehabilitation Hospital.
Among the 22 studies in Autism Spectrum Disorder by Holland Bloorview Kids Rehabilitation Hospital, this one is the 17th largest by planned enrollment of the 21 interventional ones that give a count, is the only one that started in 2023, is one of 9 in phase 2, and was the 22nd registered.
1,727 studies on the registry are indexed under Autism Spectrum Disorder; 500 are open to participants now.
Browse Autism Spectrum Disorder studies →5 of the 22 studies in Autism Spectrum Disorder by Holland Bloorview Kids Rehabilitation Hospital are open now, in 1 country. Recruiting first, the newest first:
Holland Bloorview Kids Rehabilitation Hospital · Sites in Canada
Ages 8–17
Holland Bloorview Kids Rehabilitation Hospital · Sites in Canada
Ages 0 mo–64 mo
Holland Bloorview Kids Rehabilitation Hospital · Sites in Canada
Ages 9–18
Holland Bloorview Kids Rehabilitation Hospital · Sites in Canada
Ages 6–17
By country, each count listing its studies:
Of the 349 Autism Spectrum Disorder studies recruiting now, 48 (14%) set no upper age limit and 294 (84%) stop at 75 or younger; 298 take children under 18; 92 take healthy volunteers.
This study: 9 Years to 18 Years · all sexes · no healthy volunteers.
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22 studies; the count open now beside each. This study's row is marked.
First in 2010; this study’s year is marked. 1 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 20 is below the median of 52 across 1,370 interventional studies indexed under Autism Spectrum Disorder.
Median enrollment 60 across the 21 interventional studies, 200 across the 1 observational. Of the 14 that completed or were terminated, 3 (21%) have results posted.
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Holland Bloorview Kids Rehabilitation Hospital is the lead sponsor of 64 studies on the registry; 13 are open to participants now.
1 of the studies in Autism Spectrum Disorder by Holland Bloorview Kids Rehabilitation Hospital that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06081348Holland Bloorview Kids Rehabilitation HospitalSertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents With NeurodevelopMental Disorders | 2027-09 |
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Among the 22 studies in Autism Spectrum Disorder by Holland Bloorview Kids Rehabilitation Hospital, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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..
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
active tDCS
Device: At-home transcranial direct current stimulation (tDCS)
sham tDCS
Device: Sham at-home tDCS
30 minutes session 5 days/week for 3 weeks.
30 minutes session 5 days/week for 3 weeks.
Recruitment
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
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2023 (actual). Primary completion is estimated for Sep 2025, 23 months after the start.
Of 67 non-industry phase 2 interventional studies under Autism Spectrum Disorder, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 63. This study's planned 23 months is below that.
Counting every sponsor, half of 82 studies reached it within 36 months; a quarter within 23 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
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Holland Bloorview Kids Rehabilitation Hospital