Repetitive Transcranial Magnetic Stimulation to Promote Helpful Self-regulatory Behaviour in Children and Youth With Autism Spectrum Disorder
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Autism Spectrum Disorder
- Sponsor
- Holland Bloorview Kids Rehabilitation Hospital
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Recruitment
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Deryk Beal
Clinician-Scientist
Holland Bloorview Kids Rehabilitation Hospital
Eligibility 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.)
Outcomes
Primary Outcomes
Recruitment
Time Frame: Weeks 1-18
Recruitment rates of 4 participants/month are achieved with a ≥ 20% response rate
Blinding success
Time Frame: 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
Time Frame: Weeks 1-18
90% of participants who complete assessment achieve the target intensity and dose (15 rTMS sessions)
Attrition
Time Frame: Weeks 1-18
Attrition rates of less than 10% (i.e., ≥90% of participants successfully complete assessments).
Secondary Outcomes
- Clinical Measure of Self-Regulation: The Response To Stress Questionnaire - Family Stress(Weeks 1, 6, 18)
- Clinical Measure of Self-regulation: Aberrant Behaviour Checklist - Irritability Subscale(Weeks 1, 6, 18)
- Clinical Measure of Self-regulation: Emotional Regulation Checklist(Weeks 1, 6, 18)
- Inhibitory control(Weeks 1, 6, 18)
- Structural brain changes (magnetic resonance imaging)(Weeks 1, 6, 18)
- Functional brain changes (magnetic resonance imaging)(Weeks 1, 6, 18)
- Clinical Measure of Self-regulation: Emotion Dysregulation Index Reactivity and Dysphoria(Weeks 1, 6, 18)
- Overall Clinical Change(Weeks 1, 6, 18)