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

Holland Bloorview Kids Rehabilitation Hospital

Status and phase: Enrolling; Phase 2

Conditions: Autism Spectrum Disorder; Self-Regulation, Emotion

Treatments: Device: repetitive transcranial magnetic stimulation (rTMS); Other: Sham stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05235919

ASDSR01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 9 to 18 years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups

repetitive transcranial magnetic stimulation (rTMS)

Experimental group

Description:

Participants will receive 15 rTMS sessions for 3 weeks.

Treatment:

Device: repetitive transcranial magnetic stimulation (rTMS)

Sham

Sham Comparator group

Description:

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

Treatment:

Other: Sham stimulation