Recruiting
Phase 2

Self-regulation

Sponsor:

Holland Bloorview Kids Rehabilitation Hospital

Code:

NCT05235919

Conditions

Autism Spectrum Disorder

Self-Regulation, Emotion

Eligibility Criteria

Sex: All

Age: 9 - 18

Healthy Volunteers: Not accepted

Interventions

repetitive transcranial magnetic stimulation (rTMS)

Sham stimulation

Study Details

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.

Conditions

Autism Spectrum Disorder

Self-Regulation, Emotion

Study ID

NCT05235919

Start date

Sep 22, 2022

Status verified date

Jul, 2024

Completion date

Feb, 2025

Anticipated

Primary completion date

Feb, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 9 - 18

Healthy Volunteers: Not accepted

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.)

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: repetitive transcranial magnetic stimulation (rTMS)

Participants will receive 15 rTMS sessions for 3 weeks.

sham comparator: Sham

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

Interventions

repetitive transcranial magnetic stimulation (rTMS)

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

Sham stimulation

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

Primary outcome measure

  • Recruitment [ Time Frame: Weeks 1-18 ]
  • Attrition [ Time Frame: Weeks 1-18 ]
  • Adherence [ Time Frame: Weeks 1-18 ]
  • Blinding success [ Time Frame: Weeks 1-18 ]

Central Contacts and Locations

Central contacts

Deryk Beal, PhD

416-425-6220dbeal@hollandbloorview.ca

Locations

Bloorivew Research Institute

Recruiting

Toronto, Ontario, Canada, M4G 1R8

Contacts

Deryk Beal, PhD

416-425-6220dbeal@hollandbloorview.ca

Principal Investigator:

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

More Information

Sponsor

Holland Bloorview Kids Rehabilitation Hospital

Last update posted

Jul 26, 2024

Last verified

Jul, 2024

Keywords

  • transcranial magnetic stimulation
  • rTMS
  • MRI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Holland Bloorview Kids Rehabilitation Hospital on 2024-07-26.