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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
50
30 minutes rTMS session 5 days/week for 3 weeks.
30 minutes sham stimulation 5 days/week for 3 weeks.
Bloorivew Research Institute
Toronto, Ontario, Canada
RECRUITINGRecruitment
Recruitment rates of 4 participants/month are achieved with a ≥ 20% response rate
Time frame: Weeks 1-18
Attrition
Attrition rates of less than 10% (i.e., ≥90% of participants successfully complete assessments).
Time frame: Weeks 1-18
Adherence
90% of participants who complete assessment achieve the target intensity and dose (15 rTMS sessions)
Time frame: Weeks 1-18
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)
Time frame: Weeks 1-18
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
Time frame: Weeks 1, 6, 18
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)
Time frame: Weeks 1, 6, 18
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)
Time frame: Weeks 1, 6, 18
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Clinical Measure of Self-regulation: Emotional Regulation Checklist
change in total score on Emotional Regulation Checklist (24-96, low scores indicate worse outcomes)
Time frame: Weeks 1, 6, 18
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)
Time frame: Weeks 1, 6, 18
Inhibitory control
Go/No-Go Task Performance
Time frame: Weeks 1, 6, 18
Functional brain changes (magnetic resonance imaging)
change in blood oxygen level dependent (BOLD) signal associated with go/no-go task
Time frame: Weeks 1, 6, 18
Structural brain changes (magnetic resonance imaging)
Diffusion imaging - change in fractional anisotropy
Time frame: Weeks 1, 6, 18