Treatment to help children with autism manage their emotions
Repetitive Transcranial Magnetic Stimulation to Promote Helpful Self-regulatory Behaviour in Children and Youth With Autism Spectrum Disorder
This study is testing if a special brain treatment can help children with autism manage their emotions better and reduce disruptive behaviors.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 9 Years to 18 Years |
| Sex | All |
| Sponsor | Holland Bloorview Kids Rehabilitation Hospital Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT05235919 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility of using repetitive Transcranial Magnetic Stimulation (rTMS) to improve self-regulation in children with Autism Spectrum Disorder (ASD). Participants will undergo behavioral assessments and MRI scans before and after a 3-week treatment period, where they will be randomized to receive either rTMS or sham stimulation. The study aims to gather pilot data on the effectiveness of rTMS in reducing disruptive behaviors associated with self-regulation impairments. The ultimate goal is to inform a larger clinical trial based on the findings.
Who should consider this trial
Good fit: Ideal candidates are children diagnosed with Autism Spectrum Disorder who also experience significant self-regulation challenges.
Not a fit: Patients with autism who do not have co-morbid self-regulation disorders or those with contraindications to TMS will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve emotional regulation and reduce disruptive behaviors in children with autism.
How similar studies have performed: While the use of rTMS in this context is novel, similar studies have shown promise in other populations, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.)
Where this trial is running
Toronto, Ontario
- Bloorivew Research Institute — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Deryk Beal, PhD — Holland Bloorview Research Institute
- Study coordinator: Deryk Beal, PhD
- Email: dbeal@hollandbloorview.ca
- Phone: 416-425-6220
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.