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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-22

Study Completion Date

2025-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Autism Spectrum Disorder Self-Regulation, Emotion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized sham-controlled rTMS trial

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Participants and outcomes assessor will be blind to rTMS or sham condition.

Study Groups

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repetitive transcranial magnetic stimulation (rTMS)

Participants will receive 15 rTMS sessions for 3 weeks.

Group Type EXPERIMENTAL

repetitive transcranial magnetic stimulation (rTMS)

Intervention Type DEVICE

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

Sham

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

Group Type SHAM_COMPARATOR

Sham stimulation

Intervention Type OTHER

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

Interventions

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repetitive transcranial magnetic stimulation (rTMS)

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

Intervention Type DEVICE

Sham stimulation

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

Intervention Type OTHER

Eligibility Criteria

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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.)

Minimum Eligible Age

9 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No