Autism Spectrum DisorderPhase 2NCT05235919
Treatment to Promote Self-regulation in Children With Autism Spectrum Disorder
A Phase 2 study testing repetitive transcranial magnetic stimulation (rTMS) in people with Autism Spectrum Disorder and Self-Regulation, Emotion, run by Holland Bloorview Kids Rehabilitation Hospital at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 9 to 18 years
- Conditions the study is for
- Autism Spectrum Disorder, Self-Regulation, Emotion
- What is being tested?
- repetitive transcranial magnetic stimulation (rTMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 22 Sep 2022to Feb 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children with a diagnosis of autism spectrum disorder and self-regulation impairment or challenges
- Able to participate in rTMS
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Bloorivew Research Institute
Toronto, Ontario, M4G 1R8
Deryk Beal, PhD, 416-425-6220 ext. 3582, dbeal@hollandbloorview.ca
PhD
About this study
Official title: Repetitive Transcranial Magnetic Stimulation to Promote Helpful Self-regulatory Behaviour in Children and Youth 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.
Read the detailed 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.
- Conditions
- Autism Spectrum Disorder, Self-Regulation, Emotion
- Being tested
- repetitive transcranial magnetic stimulation (rTMS), Sham stimulation
- Keywords
- transcranial magnetic stimulation, rTMS, MRI
- Medical subject headings
- Autism Spectrum Disorder, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repetitive transcranial magnetic stimulation (rTMS)Device
30 minutes rTMS session 5 days/week for 3 weeks.
Sham stimulationOther
30 minutes sham stimulation 5 days/week for 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| repetitive transcranial magnetic stimulation (rTMS) | Experimental | Participants will receive 15 rTMS sessions for 3 weeks. Receives: Device: repetitive transcranial magnetic stimulation (rTMS) |
| Sham | Sham comparator | Participants will receive 15 sessions of sham stimulation for 3 weeks. Receives: Other: Sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
Recruitment rates of 4 participants/month are achieved with a ≥ 20% response rate
Measured: Weeks 1-18
Attrition
Attrition rates of less than 10% (i.e., ≥90% of participants successfully complete assessments).
Measured: Weeks 1-18
Adherence
90% of participants who complete assessment achieve the target intensity and dose (15 rTMS sessions)
Measured: 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)
Measured: Weeks 1-18
Secondary outcomes (8)
Clinical Measure of Self-regulation: Emotion Dysregulation Index Reactivity and Dysphoria
Change in total score on Reactivity (0-96) and Dysphoria (0-24) scales - greater scores indicates a worse outcome
Measured: Weeks 1, 6, 18
Clinical Measure of Self-Regulation: The Response To Stress Questionnaire - Family Stress
Change in total score Response To Stress Questionnaire Family Stress Version (57-228, greater score indicates worse a outcome)
Measured: Weeks 1, 6, 18
Clinical Measure of Self-regulation: Aberrant Behaviour Checklist - Irritability Subscale
Change in total score on Aberrant Behaviour Checklist - Irritability Subscale (15-60, greater score indicates a worse outcome)
Measured: Weeks 1, 6, 18
Clinical Measure of Self-regulation: Emotional Regulation Checklist
change in total score on Emotional Regulation Checklist (24-96, low scores indicate worse outcomes)
Measured: Weeks 1, 6, 18
Overall Clinical Change
Clinical Global Impression scale - 1 item on a scale from 0-7 (a change of 0.5 indicates a clinical impact of significance)
Measured: Weeks 1, 6, 18
Inhibitory control
Go/No-Go Task Performance
Measured: Weeks 1, 6, 18
Functional brain changes (magnetic resonance imaging)
change in blood oxygen level dependent (BOLD) signal associated with go/no-go task
Measured: Weeks 1, 6, 18
Structural brain changes (magnetic resonance imaging)
Diffusion imaging - change in fractional anisotropy
Measured: Weeks 1, 6, 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start22 Sep 2022
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized sham-controlled rTMS trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Holland Bloorview Kids Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Centre for Addiction and Mental Health, University of Toronto
- Responsible party
- Principal investigator, Deryk Beal, Holland Bloorview Kids Rehabilitation Hospital
- Investigators
- Deryk Beal, PhD, Principal investigator, Holland Bloorview Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05235919
- Sponsor's protocol ID
- ASDSR01
- Status last verified
- Jul 2024
- First submitted
- 10 Jan 2022
- Last updated
- 26 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26536383
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repetitive Transcranial Magnetic Stimulation to Promote Helpful Self-regulatory Behaviour in Children and Youth With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT05235919
- Acronym / sponsor ID
- ASDSR01
- Conditions
- Autism Spectrum Disorder, Self-Regulation, Emotion
- Keywords
- transcranial magnetic stimulation, rTMS, MRI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Holland Bloorview Kids Rehabilitation HospitalUniversity, hospital or other
- Collaborators
- Centre for Addiction and Mental Health, University of Toronto
- Study start
- 22 Sep 2022 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 11 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized sham-controlled rTMS trial
| Arm | Type | Receives |
|---|---|---|
| repetitive transcranial magnetic stimulation (rTMS) | Experimental | Device: repetitive transcranial magnetic stimulation (rTMS)Participants will receive 15 rTMS sessions for 3 weeks. |
| Sham | Sham comparator | Other: Sham stimulationParticipants will receive 15 sessions of sham stimulation for 3 weeks. |
Who may qualify
- Ages
- 9 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Children with a diagnosis of autism spectrum disorder and self-regulation impairment or challenges
- Able to participate in rTMS
Key exclusion criteria (3 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| repetitive transcranial magnetic stimulation (rTMS)30 minutes rTMS session 5 days/week for 3 weeks. | Device | repetitive transcranial magnetic stimulation (rTMS) |
| Sham stimulation30 minutes sham stimulation 5 days/week for 3 weeks. | Other | Sham |
Primary outcome
Recruitment
Time frame: Weeks 1-18
Recruitment rates of 4 participants/month are achieved with a ≥ 20% response rate
Attrition
Time frame: Weeks 1-18
Attrition rates of less than 10% (i.e., ≥90% of participants successfully complete assessments).
Adherence
Time frame: Weeks 1-18
90% of participants who complete assessment achieve the target intensity and dose (15 rTMS sessions)
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)
8 secondary outcomes
Clinical Measure of Self-regulation: Emotion Dysregulation Index Reactivity and Dysphoria
Time frame: Weeks 1, 6, 18
Clinical Measure of Self-Regulation: The Response To Stress Questionnaire - Family Stress
Time frame: Weeks 1, 6, 18
Clinical Measure of Self-regulation: Aberrant Behaviour Checklist - Irritability Subscale
Time frame: Weeks 1, 6, 18
Clinical Measure of Self-regulation: Emotional Regulation Checklist
Time frame: Weeks 1, 6, 18
Overall Clinical Change
Time frame: Weeks 1, 6, 18
Inhibitory control
Time frame: Weeks 1, 6, 18
Functional brain changes (magnetic resonance imaging)
Time frame: Weeks 1, 6, 18
Structural brain changes (magnetic resonance imaging)
Time frame: Weeks 1, 6, 18
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
- Background: PubMed 26536383Oberman 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deryk Beal, PhD principal investigator
Holland Bloorview Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing repetitive transcranial magnetic stimulation (rTMS) in people with Autism Spectrum Disorder and Self-Regulation, Emotion, run by Holland Bloorview Kids Rehabilitation Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Deryk Beal, PhD (416-425-6220 ext. 3582, dbeal@hollandbloorview.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (time frame: Weeks 1-18). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05235919, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2024.