Clinical trial NCT05235919: Treatment to Promote Self-regulation in Children With Autism Spectrum Disorder
Official title: Repetitive Transcranial Magnetic Stimulation to Promote Helpful Self-regulatory Behaviour in Children and Youth With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Autism Spectrum Disorder
Self-Regulation, Emotion
Keywords: transcranial magnetic stimulation
rTMS
MRI
Lead sponsor: Holland Bloorview Kids Rehabilitation Hospital
Sponsor class: OTHER
Collaborators: name: Centre for Addiction and Mental Health
name: University of Toronto
First posted: 2022-02-11
Enrollment: 50
Sex: ALL
Minimum age (years): 9
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized sham-controlled rTMS trial
Primary purpose: TREATMENT

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.

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.)

Primary outcomes:
measure: Recruitment
timeFrame: Weeks 1-18
measure: Attrition
timeFrame: Weeks 1-18
measure: Adherence
timeFrame: Weeks 1-18
measure: Blinding success
timeFrame: Weeks 1-18
Secondary outcomes:
measure: Clinical Measure of Self-regulation: Emotion Dysregulation Index Reactivity and Dysphoria
timeFrame: Weeks 1, 6, 18
measure: Clinical Measure of Self-Regulation: The Response To Stress Questionnaire - Family Stress
timeFrame: Weeks 1, 6, 18
measure: Clinical Measure of Self-regulation: Aberrant Behaviour Checklist - Irritability Subscale
timeFrame: Weeks 1, 6, 18
measure: Clinical Measure of Self-regulation: Emotional Regulation Checklist
timeFrame: Weeks 1, 6, 18
measure: Overall Clinical Change
timeFrame: Weeks 1, 6, 18
measure: Inhibitory control
timeFrame: Weeks 1, 6, 18
measure: Functional brain changes (magnetic resonance imaging)
timeFrame: Weeks 1, 6, 18
measure: Structural brain changes (magnetic resonance imaging)
timeFrame: Weeks 1, 6, 18
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Bloorivew Research Institute
state: Ontario
Study officials:
affiliation: Holland Bloorview Research Institute
name: Deryk Beal, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.