A Phase 2 interventional study of repetitive transcranial magnetic stimulation (rTMS) and Sham stimulation in Autism Spectrum Disorder and Self-Regulation, Emotion, 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 2024-07-26.
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 14th largest by planned enrollment of the 21 interventional ones that give a count, is one of 4 that started in 2022, is one of 9 in phase 2, and was the 17th 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 9–18
Holland Bloorview Kids Rehabilitation Hospital · Sites in Canada
Ages 0 mo–64 mo
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.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
22 studies; the count open now beside each. This study's row is marked.
First in 2010; this study’s year is marked. 4 started in 2022.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 50 is close to 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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This study will evaluate the feasibility of repetitive Transcranial Magnetic Stimulation (rTMS) in Autism Spectrum Disorder (ASD) with self-regulation impairment. Baseline and follow-up participant visits will include behavioral assessments of self-regulation and magnetic resonance imaging (MRI) to determine neurophysiological outcomes before and after rTMS treatment.
Children and youth with Autism Spectrum Disorder (ASD) often present with co-morbid impairments in self-regulation (e.g., difficulty managing their emotions) resulting in unhelpful regulatory approaches such as disruptive compulsive, aggressive and self-injurious behaviour. There is an urgent need to establish novel, precise and effective interventions that promote self-regulation and reduce disruptive behaviours. This project will collect pilot data on the effects of repetitive TMS in reducing disruptive behaviours in youth with ASD, in order to inform the design of a follow-up full-scale clinical trial. Youth with ASD who experience clinically significant difficulties with self-regulation and disruptive behaviour will be recruited. Participants will be randomized to rTMS or sham rTMS for 3 weeks. The overall feasibility of the trial will be assessed. The effect of rTMS on the brain mechanisms of self-regulation and clinical improvement in disruptive behaviours will also be measured. Neurophysiological outcomes, including changes in regional brain network activity for inhibition of behaviour, will be explored.
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.
Participants will receive 15 rTMS sessions for 3 weeks.
Device: repetitive transcranial magnetic stimulation (rTMS)
Participants will receive 15 sessions of sham stimulation for 3 weeks.
Other: Sham stimulation
30 minutes rTMS session 5 days/week for 3 weeks.
30 minutes sham stimulation 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 rTMS sessions)
Time frame: Weeks 1-18
Blinding success
Blinding of participants and their parents/caregivers and required study team members will be assessed using a Blinding Questionnaire indicating the perceived group membership (rTMS/sham)
Time frame: Weeks 1-18
Clinical Measure of Self-regulation: Emotion Dysregulation Index Reactivity and Dysphoria
Change in total score on Reactivity (0-96) and Dysphoria (0-24) scales - greater scores indicates a worse outcome
Time frame: Weeks 1, 6, 18
Clinical Measure of Self-Regulation: The Response To Stress Questionnaire - Family Stress
Change in total score Response To Stress Questionnaire Family Stress Version (57-228, greater score indicates worse a outcome)
Time frame: Weeks 1, 6, 18
Clinical Measure of Self-regulation: Aberrant Behaviour Checklist - Irritability Subscale
Change in total score on Aberrant Behaviour Checklist - Irritability Subscale (15-60, greater score indicates a worse outcome)
Time frame: Weeks 1, 6, 18
Clinical Measure of Self-regulation: Emotional Regulation Checklist
change in total score on Emotional Regulation Checklist (24-96, low scores indicate worse outcomes)
Time frame: Weeks 1, 6, 18
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: Weeks 1, 6, 18
Inhibitory control
Go/No-Go Task Performance
Time frame: Weeks 1, 6, 18
Functional brain changes (magnetic resonance imaging)
change in blood oxygen level dependent (BOLD) signal associated with go/no-go task
Time frame: Weeks 1, 6, 18
Structural brain changes (magnetic resonance imaging)
Diffusion imaging - change in fractional anisotropy
Time frame: Weeks 1, 6, 18
Plan to share: No
Started Sep 2022 (actual). Primary completion is estimated for Feb 2025, 29 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 29 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