Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05235919

Treatment to Promote Self-regulation in Children With Autism Spectrum Disorder

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

9 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Bloorivew Research Institute

Toronto, Ontario, M4G 1R8, Canada

Location status: Recruiting

Location contact

Deryk Beal, PhD

CONTACT

[email protected]

416-425-6220 ext. 3582

Deryk Beal, PhD, Reg. CASLPO, CCC-SLP

PRINCIPAL_INVESTIGATOR

Evdokia Anagnostou, MD

PRINCIPAL_INVESTIGATOR

PhD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Repetitive transcranial magnetic stimulation (rTMS)

Device

30 minutes rTMS session 5 days/week for 3 weeks.

Sham stimulation

Other

30 minutes sham stimulation 5 days/week for 3 weeks.

Primary outcomes

  1. Recruitment

    Time frame: Weeks 1-18

    Recruitment rates of 4 participants/month are achieved with a ≥ 20% response rate

  2. Attrition

    Time frame: Weeks 1-18

    Attrition rates of less than 10% (i.e., ≥90% of participants successfully complete assessments).

  3. Adherence

    Time frame: Weeks 1-18

    90% of participants who complete assessment achieve the target intensity and dose (15 rTMS sessions)

  4. 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)

Secondary outcomes

  1. Clinical Measure of Self-regulation: Emotion Dysregulation Index Reactivity and Dysphoria

    Time frame: Weeks 1, 6, 18

    Change in total score on Reactivity (0-96) and Dysphoria (0-24) scales - greater scores indicates a worse outcome

  2. Clinical Measure of Self-Regulation: The Response To Stress Questionnaire - Family Stress

    Time frame: Weeks 1, 6, 18

    Change in total score Response To Stress Questionnaire Family Stress Version (57-228, greater score indicates worse a outcome)

  3. Clinical Measure of Self-regulation: Aberrant Behaviour Checklist - Irritability Subscale

    Time frame: Weeks 1, 6, 18

    Change in total score on Aberrant Behaviour Checklist - Irritability Subscale (15-60, greater score indicates a worse outcome)

  4. Clinical Measure of Self-regulation: Emotional Regulation Checklist

    Time frame: Weeks 1, 6, 18

    change in total score on Emotional Regulation Checklist (24-96, low scores indicate worse outcomes)

  5. Overall Clinical Change

    Time frame: 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)

  6. Inhibitory control

    Time frame: Weeks 1, 6, 18

    Go/No-Go Task Performance

  7. Functional brain changes (magnetic resonance imaging)

    Time frame: Weeks 1, 6, 18

    change in blood oxygen level dependent (BOLD) signal associated with go/no-go task

  8. Structural brain changes (magnetic resonance imaging)

    Time frame: Weeks 1, 6, 18

    Diffusion imaging - change in fractional anisotropy

Study contacts

Contact information is provided by the study sponsor or research team.

Deryk Beal, PhD

CONTACT

[email protected]

416-425-6220 ext. 3582

Sponsors and collaborators

Lead sponsor

Holland Bloorview Kids Rehabilitation Hospital

Other

Collaborators

  • Centre for Addiction and Mental Health
  • University of Toronto

Registry information

Official study title

Repetitive Transcranial Magnetic Stimulation to Promote Helpful Self-regulatory Behaviour in Children and Youth With Autism Spectrum Disorder

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Feb 11, 2022
Registry last updated
Jul 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.