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Device

rTMS for Autism

Phase 2
Recruiting
Led By Deryk Beal, PhD
Research Sponsored by Holland Bloorview Kids Rehabilitation Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Children with a diagnosis of autism spectrum disorder and self-regulation impairment or challenges
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 1, 6, 18
Awards & highlights

Study Summary

This trial will test if a non-invasive brain stimulation treatment can help improve self-regulation in people with ASD.

Who is the study for?
This trial is for children with Autism Spectrum Disorder who struggle with self-regulation. They must be able to undergo rTMS treatment safely, meaning no history of seizures, family history of seizures, metal implants in the body, or other neurological conditions like epilepsy.Check my eligibility
What is being tested?
The study tests if repetitive Transcranial Magnetic Stimulation (rTMS) can help kids with Autism manage their emotions and behaviors better. It includes a comparison between actual rTMS and sham (fake) stimulation alongside behavioral assessments and MRI scans before and after treatment.See study design
What are the potential side effects?
Possible side effects from rTMS may include discomfort at the stimulation site, headache, lightheadedness, or tingling. There's also a low risk of seizure but it's generally considered safe when standard guidelines are followed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My child has autism and struggles with self-regulation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 1, 6, 18
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 1, 6, 18 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adherence
Attrition
Blinding success
+1 more
Secondary outcome measures
Clinical Measure of Self-Regulation: The Response To Stress Questionnaire - Family Stress
Clinical Measure of Self-regulation: Aberrant Behaviour Checklist - Irritability Subscale
Clinical Measure of Self-regulation: Emotion Dysregulation Index Reactivity and Dysphoria
+5 more

Side effects data

From 2005 Phase 2 trial • 50 Patients • NCT00004980
59%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Active Repetitive Transcanial Magnetic Stimulation
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: repetitive transcranial magnetic stimulation (rTMS)Experimental Treatment1 Intervention
Participants will receive 15 rTMS sessions for 3 weeks.
Group II: ShamPlacebo Group1 Intervention
Participants will receive 15 sessions of sham stimulation for 3 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
repetitive transcranial magnetic stimulation (rTMS)
2003
Completed Phase 2
~380

Find a Location

Who is running the clinical trial?

Holland Bloorview Kids Rehabilitation HospitalLead Sponsor
67 Previous Clinical Trials
14,024 Total Patients Enrolled
Centre for Addiction and Mental HealthOTHER
356 Previous Clinical Trials
81,394 Total Patients Enrolled
University of TorontoOTHER
690 Previous Clinical Trials
1,019,593 Total Patients Enrolled
1 Trials studying Emotional Regulation
135 Patients Enrolled for Emotional Regulation

Media Library

repetitive transcranial magnetic stimulation (rTMS) (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05235919 — Phase 2
Emotional Regulation Research Study Groups: repetitive transcranial magnetic stimulation (rTMS), Sham
Emotional Regulation Clinical Trial 2023: repetitive transcranial magnetic stimulation (rTMS) Highlights & Side Effects. Trial Name: NCT05235919 — Phase 2
repetitive transcranial magnetic stimulation (rTMS) (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05235919 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment for this clinical trial limited to adults who are over 60 years of age?

"Within the age range of 9 and 18 years old, this trial is accepting enrollees."

Answered by AI

Does the FDA sanction repetitive transcranial magnetic stimulation (rTMS) as a legitimate treatment?

"Considering prior clinical data that has established a foundation of safety, our team at Power assigned a score of 2 to repetitive transcranial magnetic stimulation (rTMS). This Phase 2 trial does not yet have evidence for efficacy."

Answered by AI

Are there any openings for participants in this clinical experiment?

"According to clinicaltrials.gov, this medical trial is actively enrolling patients and has been since September 22nd 2022 - the last update was posted on October 28th 2022."

Answered by AI

What is the current number of participants in this clinical experiment?

"Confirmed. According to the clinicaltrials.gov database, this medical trial is recruiting participants with an initial advertisement posted on September 22nd 2022 and a recent update issued October 28th 2022. A total of fifty patients are needed at one site for enrolment in the study."

Answered by AI

What characteristics make an individual suitable for this medical research?

"This investigation is recruiting 50 individuals aged between 9 and 18 that have been diagnosed with autism spectrum disorder. It is essential for those selected to meet the following conditions: having a diagnosis of ASD plus issues with self-regulation, as well as being able to partake in rTMS treatments."

Answered by AI

What is the intended outcome of this experiment?

"This trial will span 18 weeks, with the primary goal of participant recruitment. Secondary metrics include functional MRI changes associated with go/no-go tasks, diffusion imaging to measure fractional anisotropy, and a clinical questionnaire focused on measuring irritability."

Answered by AI

Who else is applying?

What state do they live in?
Florida
New York
Pennsylvania
Other
How old are they?
< 18
18 - 65
What site did they apply to?
Bloorivew Research Institute
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

How responsive is this trial?

Typically responds via
Email
Recent research and studies
Autism ResearchJournal
Transcranial Magnetic Stimulation in Autism Spectrum Disorder: Challenges, Promise, and Roadmap for Future Research
Oberman, Lindsay M., Peter G. Enticott, Manuel F. Casanova, Alexander Rotenberg, Alvaro Pascual-Leone, James T. McCracken, and the TMS in ASD Consensus Group. 2015. “Transcranial Magnetic Stimulation in Autism Spectrum Disorder: Challenges, Promise, and Roadmap for Future Research”. Autism Research. Wiley. doi:10.1002/aur.1567.
clinicaltrials.govStudy
Treatment to Promote Self-regulation in Children With Autism Spectrum Disorder
Deryk Beal 2022. "Treatment to Promote Self-regulation in Children With Autism Spectrum Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05235919.
All > Asd > Transcranial Magnetic Stimulation
~16 spots leftby Feb 2025
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