Autism Spectrum Disorder, Self-Regulation, Emotion
Conditions
Keywords
transcranial magnetic stimulation, rTMS, MRI
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.
Interventions
DEVICErepetitive transcranial magnetic stimulation (rTMS)
30 minutes rTMS session 5 days/week for 3 weeks.
OTHERSham stimulation
30 minutes sham stimulation 5 days/week for 3 weeks.
Sponsors
Centre for Addiction and Mental Health
University of Toronto
Holland Bloorview Kids Rehabilitation Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Participants and outcomes assessor will be blind to rTMS or sham condition.
Intervention model description
Randomized sham-controlled rTMS trial
Eligibility
Sex/Gender
ALL
Age
9 Years to 18 Years
Healthy volunteers
No
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment | Weeks 1-18 | Recruitment rates of 4 participants/month are achieved with a ≥ 20% response rate |
| Attrition | Weeks 1-18 | Attrition rates of less than 10% (i.e., ≥90% of participants successfully complete assessments). |
| Adherence | Weeks 1-18 | 90% of participants who complete assessment achieve the target intensity and dose (15 rTMS sessions) |
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Inhibitory control | Weeks 1, 6, 18 | Go/No-Go Task Performance |
| 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 |
| Structural brain changes (magnetic resonance imaging) | Weeks 1, 6, 18 | Diffusion imaging - change in fractional anisotropy |
| 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) |
Countries
Canada
Contacts
Primary ContactDeryk Beal, PhD
Outcome results
None listed