NCT05235919

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 11, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

September 22, 2022

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

July 26, 2024

Status Verified

July 1, 2024

Enrollment Period

2.4 years

First QC Date

January 10, 2022

Last Update Submit

July 25, 2024

Conditions

Autism Spectrum DisorderSelf-Regulation, Emotion

Keywords

transcranial magnetic stimulationrTMSMRI

Outcome Measures

Primary Outcomes (4)

  • Recruitment

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

    Weeks 1-18

  • Attrition

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

    Weeks 1-18

  • Adherence

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

    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)

    Weeks 1-18

Secondary Outcomes (8)

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

    Weeks 1, 6, 18

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

    Weeks 1, 6, 18

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

    Weeks 1, 6, 18

  • Clinical Measure of Self-regulation: Emotional Regulation Checklist

    Weeks 1, 6, 18

  • Overall Clinical Change

    Weeks 1, 6, 18

  • +3 more secondary outcomes

Study Arms (2)

repetitive transcranial magnetic stimulation (rTMS)

EXPERIMENTAL

Participants will receive 15 rTMS sessions for 3 weeks.

Device: repetitive transcranial magnetic stimulation (rTMS)

Sham

SHAM COMPARATOR

Participants will receive 15 sessions of sham stimulation for 3 weeks.

Other: Sham stimulation

Interventions

repetitive transcranial magnetic stimulation (rTMS)DEVICE

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

repetitive transcranial magnetic stimulation (rTMS)
Sham stimulationOTHER

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

Sham

Eligibility Criteria

Age9 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children with a diagnosis of autism spectrum disorder and self-regulation impairment or challenges
  • Able to participate in rTMS

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bloorivew Research Institute

Toronto, Ontario, M4G 1R8, Canada

RECRUITING

Related Publications (1)

  • 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.

    PMID: 26536383BACKGROUND

MeSH Terms

Conditions

Autism Spectrum DisorderEmotional Regulation

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersSelf-ControlSocial BehaviorBehavior

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Deryk Beal, PhD

    Holland Bloorview Research Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Deryk Beal, PhD

CONTACT

416-425-6220dbeal@hollandbloorview.ca

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Participants and outcomes assessor will be blind to rTMS or sham condition.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized sham-controlled rTMS trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinician-Scientist

Study Record Dates

First Submitted

January 10, 2022

First Posted

February 11, 2022

Study Start

September 22, 2022

Primary Completion

February 1, 2025

Study Completion

February 1, 2025

Last Updated

July 26, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)