RecruitingPhase 2

Treatment to Promote Self-regulation in Children With Autism Spectrum Disorder

Canada50 participantsStarted 2022-09-22

Plain-language summary

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.

Who can participate

Age range

9 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Children with a diagnosis of autism spectrum disorder and self-regulation impairment or challenges * Able to participate in rTMS Exclusion Criteria: * Children with autism spectrum disorder but no co-morbid self-regulation disorders. * Children with contraindications to TMS (history of seizures, family history of seizures, metal implants) * Co-existing neurological conditions (epilepsy, stroke, etc.)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Recruitment

Timeframe: Weeks 1-18

Attrition

Timeframe: Weeks 1-18

Adherence

Timeframe: Weeks 1-18

Blinding success

Timeframe: Weeks 1-18

Trial details

NCT IDNCT05235919

SponsorHolland Bloorview Kids Rehabilitation Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-02

Contact for this trial

Deryk Beal, PhD

416-425-6220 dbeal@hollandbloorview.ca

View on ClinicalTrials.gov More Autism Spectrum Disorder trials

Plain-language summary

Who can participate

Age range

9 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.