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

Phase 2

Recruiting

• Conditions: Autism Spectrum Disorder; Self-Regulation, Emotion
• Interventions: Device: repetitive transcranial magnetic stimulation (rTMS); Other: Sham stimulation

• Registration Number: NCT05235919
• Lead Sponsor: Holland Bloorview Kids Rehabilitation Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-01-10
• Study First Submitted QC: 2022-02-10
• Study First Posted: 2022-02-11
• Study Start: 2022-09-22
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-25
• Last Update Posted: 2024-07-26
• Primary Completion: 2025-02
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
repetitive transcranial magnetic stimulation (rTMS)	repetitive transcranial magnetic stimulation (rTMS)	Participants will receive 15 rTMS sessions for 3 weeks.
Sham	Sham stimulation	Participants will receive 15 sessions of sham stimulation for 3 weeks.

Primary Outcome Measures

Name	Time	Method
Attrition	Weeks 1-18	Attrition rates of less than 10% (i.e., ≥90% of participants successfully complete assessments).
Recruitment	Weeks 1-18	Recruitment rates of 4 participants/month are achieved with a ≥ 20% response rate
Blinding success	Weeks 1-18	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)
Adherence	Weeks 1-18	90% of participants who complete assessment achieve the target intensity and dose (15 rTMS sessions)

Secondary Outcome Measures

Name	Time	Method
Functional brain changes (magnetic resonance imaging)	Weeks 1, 6, 18	change in blood oxygen level dependent (BOLD) signal associated with go/no-go task
Clinical Measure of Self-Regulation: The Response To Stress Questionnaire - Family Stress	Weeks 1, 6, 18	Change in total score Response To Stress Questionnaire Family Stress Version (57-228, greater score indicates worse a outcome)
Clinical Measure of Self-regulation: Aberrant Behaviour Checklist - Irritability Subscale	Weeks 1, 6, 18	Change in total score on Aberrant Behaviour Checklist - Irritability Subscale (15-60, greater score indicates a worse outcome)
Clinical Measure of Self-regulation: Emotional Regulation Checklist	Weeks 1, 6, 18	change in total score on Emotional Regulation Checklist (24-96, low scores indicate worse outcomes)
Inhibitory control	Weeks 1, 6, 18	Go/No-Go Task Performance
Structural brain changes (magnetic resonance imaging)	Weeks 1, 6, 18	Diffusion imaging - change in fractional anisotropy
Clinical Measure of Self-regulation: Emotion Dysregulation Index Reactivity and Dysphoria	Weeks 1, 6, 18	Change in total score on Reactivity (0-96) and Dysphoria (0-24) scales - greater scores indicates a worse outcome
Overall Clinical Change	Weeks 1, 6, 18	Clinical Global Impression scale - 1 item on a scale from 0-7 (a change of 0.5 indicates a clinical impact of significance)

Trial Locations

Locations (1)

Bloorivew Research Institute; 🇨🇦 Toronto, Ontario, Canada