Treatment to Promote Self-regulation in Children With Autism Spectrum Disorder
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age9-18
SponsorHolland Bloorview Kids Rehabilitation Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children with a diagnosis of autism spectrum disorder and self-regulation impairment or challenges
Able to participate in rTMS
Disqualifiers
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.)
Trial design
Design model
Parallel
Treatments tested in this trial
repetitive transcranial magnetic stimulation (rTMS)
Device30 minutes rTMS session 5 days/week for 3 weeks.
Sham stimulation
Other intervention30 minutes sham stimulation 5 days/week for 3 weeks.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: repetitive transcranial magnetic stimulation (rTMS)Experimental treatment 1 intervention
Group B: ShamSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Recruitment
Recruitment rates of 4 participants/month are achieved with a ≥ 20% response rate
Time frame
Weeks 1-182
Attrition
Attrition rates of less than 10% (i.e., ≥90% of participants successfully complete assessments).
Time frame
Weeks 1-183
Adherence
90% of participants who complete assessment achieve the target intensity and dose (15 rTMS sessions)
Time frame
Weeks 1-184
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 1-18Secondary outcomes
1
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, 182
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, 183
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, 184
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, 18Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Holland Bloorview Kids Rehabilitation Hospital
Lead sponsor
Centre for Addiction and Mental Health
Collaborator
University of Toronto
Collaborator
Source ClinicalTrials.gov