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

Autism Spectrum Disorder Clinical Trial

Official title:

Repetitive Transcranial Magnetic Stimulation to Promote Helpful Self-regulatory Behaviour in Children and Youth With Autism Spectrum Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05235919
• Other study ID #: ASDSR01
• Status: Recruiting
• Phase: Phase 2
• Start date: September 22, 2022
• Est. completion date: February 2025

Study information

• Verified date: October 2022
• Source: Holland Bloorview Kids Rehabilitation Hospital
• Contact: Trina Mitchell, PhD
• Phone: 416-425-6220
• Email: tmitchell[@]hollandbloorview.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 18 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

Device:
• repetitive transcranial magnetic stimulation (rTMS)
30 minutes rTMS session 5 days/week for 3 weeks.

Other:
• Sham stimulation
30 minutes sham stimulation 5 days/week for 3 weeks.

Locations

Country	Name	City	State
Canada	Bloorivew Research Institute	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Holland Bloorview Kids Rehabilitation Hospital	Centre for Addiction and Mental Health, University of Toronto

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Oberman LM, Enticott PG, Casanova MF, Rotenberg A, Pascual-Leone A, McCracken JT; TMS in ASD Consensus Group. Transcranial magnetic stimulation in autism spectrum disorder: Challenges, promise, and roadmap for future research. Autism Res. 2016 Feb;9(2):184-203. doi: 10.1002/aur.1567. Epub 2015 Nov 4. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment	Recruitment rates of 4 participants/month are achieved with a = 20% response rate	Weeks 1-18
Primary	Attrition	Attrition rates of less than 10% (i.e., =90% of participants successfully complete assessments).	Weeks 1-18
Primary	Adherence	90% of participants who complete assessment achieve the target intensity and dose (15 rTMS sessions)	Weeks 1-18
Primary	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)	Weeks 1-18
Secondary	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	Weeks 1, 6, 18
Secondary	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)	Weeks 1, 6, 18
Secondary	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)	Weeks 1, 6, 18
Secondary	Clinical Measure of Self-regulation: Emotional Regulation Checklist	change in total score on Emotional Regulation Checklist (24-96, low scores indicate worse outcomes)	Weeks 1, 6, 18
Secondary	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)	Weeks 1, 6, 18
Secondary	Inhibitory control	Go/No-Go Task Performance	Weeks 1, 6, 18
Secondary	Functional brain changes (magnetic resonance imaging)	change in blood oxygen level dependent (BOLD) signal associated with go/no-go task	Weeks 1, 6, 18
Secondary	Structural brain changes (magnetic resonance imaging)	Diffusion imaging - change in fractional anisotropy	Weeks 1, 6, 18