Autism Spectrum Disorder(AMBLE Autism)NCT06497920
rTMS to Improve Motor Function in Autism
A study testing Active rTMS to the motor cortex in people with Autism Spectrum Disorder and Motor Activity, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
In the current project, investigators have two main goals: i) Testing whether an excessive plasticity, i.e. hyperplasticity in the motor cortex underlies motor function difficulties in autistic adults, and ii) Using repetitive Transcranial Magnetic Stimulation (rTMS) with autistic adults to examine whether resulting… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Motor Activity
- What is being tested?
- Active rTMS to the motor cortex
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- 24 Apr 2024to 30 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ASD or control participants must meet all of the inclusion criteria to eligible for this study:
- Aged between 18 and 40 years old. 40 years is chosen as the cut-off because of the report of high rates of Parkinsonism in autistic adults > 39years;
- Have IQ>70;
- Are able to read, write and communicate effectively in English;
- Are able to provide informed consent. We will recruit only intellectually-able autistic adults. The intellectual ability will be determined using WASI-II. The ability to provide consent will be determined using clinical assessment.
- Have no prior history of seizure;
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- Must sign and date the informed consent form;
- Stated willingness to comply with all study procedures;
- Agreement to adhere to Lifestyle Considerations, that is: refrain from consumption of alcohol, tobacco, marijuana, or caffeine on the day of study visits.
- All ASD participants:
- Will have DSM-5 diagnosis of ASD without intellectual disability, confirmed by clinical assessment and the Autism Diagnostic Observation Schedule - 2 (ADOS-2);
- Will have significant motor function difficulties defined as a standard composite score <40 (i.e., >1 standard deviation below the mean) on either fine or gross motor composite scores of the Bruininks-Oseretsky Test of Motor Proficiency, Second Edition or BOT-2;
- Are clinically stable as determined by clinical assessment, with no medication changes over the past 4 weeks. Given the high variability of handedness in ASD, we will include participants with left, right or mixed handedness.
Who cannot join
- ASD or control participants will be excluded if they experience/have:
- Current pregnancy;
- Current or past history of co-morbid medical condition that may require urgent medical intervention;
- DSM-5 substance use disorder (other than tobacco) within the past 6 months; however, all participants will be asked to refrain from smoking or taking caffeine four hours prior to the iTBS session;
- Significant hearing or visual impairment interfering with the ability to read or hear instructions;
- Significantly debilitating medical or neurologic illness (e.g., encephalitis, aneurysms, tumors, central nervous system infections), or acute or unstable medical illnesses as determined by project physician (e.g., uncontrolled diabetes);
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- Metal implants or a pace-maker;
- Prior rTMS treatment;
- In addition, ASD participants will be excluded if they report taking benzodiazepines or anticonvulsants currently.
- NT controls will be excluded if they have:
- Presence of psychopathology other than specific phobia, as screened by Personality Assessment Inventory and;
- A known diagnosis of Pervasive Developmental Disorder or ASD among any biologically related family members.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Center for Addiction and Mental Health (CAMH)
Toronto, Ontario, M6J 1H4
Pushpal Desarkar, MD, 4165358501 ext. 32726, Pushpal.Desarkar@camh.ca
About this study
Official title: Modulating Plasticity in the Motor Cortex Using Repetitive Transcranial Magnetic Stimulation to Improve Motor Function in Autism Spectrum Disorder
In the current project, investigators have two main goals: i) Testing whether an excessive plasticity, i.e. hyperplasticity in the motor cortex underlies motor function difficulties in autistic adults, and ii) Using repetitive Transcranial Magnetic Stimulation (rTMS) with autistic adults to examine whether resulting reduced hyperplasticity in the motor cortex will be associated with clinical improvements in the motor function.
Read the detailed description
Autism spectrum disorder (ASD) is a very common developmental condition, yet the cause remains unknown and effective treatment options to improve outcomes remain limited. Most autistic adults experience significant motor function difficulties involving balance, posture, coordination, and strength that negatively affect their quality of life, social interaction, confidence and daily functioning. Therefore, such difficulties remain an important treatment target. However, there are no known effective clinical interventions for such difficulties. Investigators previously showed that the part of the brain that controls motor movements, i.e. motor cortex, showed hyperplasticity, as assessed by theta-burst magnetic brain stimulation (TBS), in autistic adults. Hyperplasticity may adversely affect brain health and behavior. Investigators also previously found that rTMS may reduce such hyperplasticity in the motor cortex in autistic adults.
In this project, 100 autistic adults with significant motor function difficulties and 50 neurotypical (NT) controls matched 2:1 based on age, sex, and IQ will be recruited. At the Centre for Addiction and Mental Health, Toronto, each autistic adult's participation will consist of six visits, while each NT adult's participation will include two visits.
All participants, both autistic and NT, will undergo clinical, adaptive, and motor function assessments during their first visit (lasting approximately 3 hours) and a pre- and post-intermittent-TBS (iTBS) session, paired with electroencephalography (EEG), to induce and assess plasticity in the left or right motor cortex (depending on handedness) during their second visit (lasting approximately 3 hours). Based on the preliminary evidence that rTMS reduces hyperplasticity in the motor cortex in autistic adults, the investigators will then use a randomized, double-blind, sham-controlled design for bilateral 3-session rTMS on the motor cortex. Autistic participants will be randomized (1:1, sex-stratified) to receive either active or sham rTMS (150 trains of 40 pulses with an inter-train interval of 25 seconds, delivered at 90% of the resting motor threshold for both conditions) three days a week (approximately 1.5 hours each), from their third to fifth visits (total of 3 sessions). Assessment of motor and adaptive function, and plasticity in the motor cortex will be repeated the next day after the last rTMS session (i.e. 3rd rTMS session).
- Conditions
- Autism Spectrum Disorder, Motor Activity
- Being tested
- Active rTMS to the motor cortex, Sham rTMS to the motor cortex
- Keywords
- Autism, Motor Function, Repetitive Transcranial Magnetic Stimulation, Transcranial Magnetic Stimulation, Motor Cortex, Electroencephalography
- Medical subject headings
- Autism Spectrum Disorder, Motor Activity, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active rTMS to the motor cortexDevice
Active bilateral repetitive transcranial magnetic stimulation to the motor cortex
Sham rTMS to the motor cortexDevice
Sham bilateral repetitive transcranial magnetic stimulation to the motor cortex
| Study group | Role | What they receive |
|---|---|---|
| Active rTMS | Active comparator | Autistic adults receiving active rTMS to the motor cortex. Receives: Device: Active rTMS to the motor cortex |
| Sham rTMS | Sham comparator | Autistic adults receiving sham rTMS to the motor cortex. Receives: Device: Sham rTMS to the motor cortex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in motor cortical plasticity using motor evoked potentials (MEPs) in autistic adults following rTMS.
Plasticity will be indexed by the duration of facilitation of motor evoked potentials (MEPs) amplitude, i.e. the time for the MEP amplitude to return to baseline values following iTBS.
Measured: Plasticity in the motor cortex will be evaluated at baseline and the day after the final rTMS session.
Secondary outcomes (3)
Changes in motor cortical plasticity using cortical evoked activity (CEA) in autistic adults following rTMS.
A secondary measure of plasticity will be indexed by the maximum post-iTBS/pre-iTBS cortical evoked activity (CEA) ratio. CEA will be defined as the area under rectified curve for averaged electroencephalography (EEG) recordings in the electrode over motor cortex between 50-275 millisecond post-stimulus.
Measured: Plasticity in the motor cortex will be evaluated at baseline and the day after the final rTMS session.
Changes in the adaptive daily living skills in autistic adults following rTMS.
The daily living skills domain of Adaptive Behavior Assessment System-3rd edition will be used to assess adaptive daily living skills. A higher score represents better adaptive skills.
Measured: Adaptive daily living skills will be assessed at baseline and the day after the final rTMS session.
Changes in motor function in autistic adults following rTMS.
Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2) will be used to assess motor function. The total motor composite score will be used as the primary measure of motor function. A higher score on BOT-2 indicates better motor performance.
Measured: Motor function will be assessed at baseline and the day after the final rTMS.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start24 Apr 2024
- Primary completion30 Apr 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This project includes a randomized controlled trial. We will use a randomized, double- blind, sham-controlled design comparing the efficacy of active vs. sham rTMS (6000 pulses at 20 Hz/session, 3000 pulses/hemisphere with 5-10 min break in between) delivered to the motor cortex using bilaterally, 1 session/day for 3 consecutive days (3 sessions). Pulses will be delivered to one hemisphere (left or right) first, followed by the opposite side. The sequence will be randomized for each participant.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06497920
- Sponsor's protocol ID
- 2023/180
- Acronym
- (AMBLE Autism)
- Status last verified
- Jun 2026
- First submitted
- 13 Jun 2024
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulating Plasticity in the Motor Cortex Using Repetitive Transcranial Magnetic Stimulation to Improve Motor Function in Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT06497920
- Acronym / sponsor ID
- (AMBLE Autism) / 2023/180
- Conditions
- Autism Spectrum Disorder, Motor Activity
- Keywords
- Autism, Motor Function, Repetitive Transcranial Magnetic Stimulation, Transcranial Magnetic Stimulation, Motor Cortex, Electroencephalography
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- 24 Apr 2024 (actual)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 12 Jul 2024 (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.
In the current project, investigators have two main goals: i) Testing whether an excessive plasticity, i.e. hyperplasticity in the motor cortex underlies motor function difficulties in autistic adults, and ii) Using repetitive Transcranial Magnetic Stimulation (rTMS) with autistic adults to examine whether resulting reduced hyperplasticity in the motor cortex will be associated with clinical improvements in the motor function.
Detailed description
Autism spectrum disorder (ASD) is a very common developmental condition, yet the cause remains unknown and effective treatment options to improve outcomes remain limited. Most autistic adults experience significant motor function difficulties involving balance, posture, coordination, and strength that negatively affect their quality of life, social interaction, confidence and daily functioning. Therefore, such difficulties remain an important treatment target. However, there are no known effective clinical interventions for such difficulties. Investigators previously showed that the part of the brain that controls motor movements, i.e. motor cortex, showed hyperplasticity, as assessed by theta-burst magnetic brain stimulation (TBS), in autistic adults. Hyperplasticity may adversely affect brain health and behavior. Investigators also previously found that rTMS may reduce such hyperplasticity in the motor cortex in autistic adults.
In this project, 100 autistic adults with significant motor function difficulties and 50 neurotypical (NT) controls matched 2:1 based on age, sex, and IQ will be recruited. At the Centre for Addiction and Mental Health, Toronto, each autistic adult's participation will consist of six visits, while each NT adult's participation will include two visits.
All participants, both autistic and NT, will undergo clinical, adaptive, and motor function assessments during their first visit (lasting approximately 3 hours) and a pre- and post-intermittent-TBS (iTBS) session, paired with electroencephalography (EEG), to induce and assess plasticity in the left or right motor cortex (depending on handedness) during their second visit (lasting approximately 3 hours). Based on the preliminary evidence that rTMS reduces hyperplasticity in the motor cortex in autistic adults, the investigators will then use a randomized, double-blind, sham-controlled design for bilateral 3-session rTMS on the motor cortex. Autistic participants will be randomized (1:1, sex-stratified) to receive either active or sham rTMS (150 trains of 40 pulses with an inter-train interval of 25 seconds, delivered at 90% of the resting motor threshold for both conditions) three days a week (approximately 1.5 hours each), from their third to fifth visits (total of 3 sessions). Assessment of motor and adaptive function, and plasticity in the motor cortex will be repeated the next day after the last rTMS session (i.e. 3rd rTMS session).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This project includes a randomized controlled trial. We will use a randomized, double- blind, sham-controlled design comparing the efficacy of active vs. sham rTMS (6000 pulses at 20 Hz/session, 3000 pulses/hemisphere with 5-10 min break in between) delivered to the motor cortex using bilaterally, 1 session/day for 3 consecutive days (3 sessions). Pulses will be delivered to one hemisphere (left or right) first, followed by the opposite side. The sequence will be randomized for each participant.
| Arm | Type | Receives |
|---|---|---|
| Active rTMS | Active comparator | Device: Active rTMS to the motor cortexAutistic adults receiving active rTMS to the motor cortex. |
| Sham rTMS | Sham comparator | Device: Sham rTMS to the motor cortexAutistic adults receiving sham rTMS to the motor cortex. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- ASD or control participants must meet all of the inclusion criteria to eligible for this study:
- Aged between 18 and 40 years old. 40 years is chosen as the cut-off because of the report of high rates of Parkinsonism in autistic adults > 39years;
- Have IQ>70;
- Are able to read, write and communicate effectively in English;
- Are able to provide informed consent. We will recruit only intellectually-able autistic adults. The intellectual ability will be determined using WASI-II. The ability to provide consent will be determined using clinical assessment.
Key exclusion criteria (12 listed)
- Current pregnancy;
- Current or past history of co-morbid medical condition that may require urgent medical intervention;
- DSM-5 substance use disorder (other than tobacco) within the past 6 months; however, all participants will be asked to refrain from smoking or taking caffeine four hours prior to the iTBS session;
- Significant hearing or visual impairment interfering with the ability to read or hear instructions;
- Significantly debilitating medical or neurologic illness (e.g., encephalitis, aneurysms, tumors, central nervous system infections), or acute or unstable medical illnesses as determined by project physician (e.g., uncontrolled diabetes);
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 |
|---|---|---|
| Active rTMS to the motor cortexActive bilateral repetitive transcranial magnetic stimulation to the motor cortex | Device | Active rTMS |
| Sham rTMS to the motor cortexSham bilateral repetitive transcranial magnetic stimulation to the motor cortex | Device | Sham rTMS |
Primary outcome
Changes in motor cortical plasticity using motor evoked potentials (MEPs) in autistic adults following rTMS.
Time frame: Plasticity in the motor cortex will be evaluated at baseline and the day after the final rTMS session.
Plasticity will be indexed by the duration of facilitation of motor evoked potentials (MEPs) amplitude, i.e. the time for the MEP amplitude to return to baseline values following iTBS.
3 secondary outcomes
Changes in motor cortical plasticity using cortical evoked activity (CEA) in autistic adults following rTMS.
Time frame: Plasticity in the motor cortex will be evaluated at baseline and the day after the final rTMS session.
Changes in the adaptive daily living skills in autistic adults following rTMS.
Time frame: Adaptive daily living skills will be assessed at baseline and the day after the final rTMS session.
Changes in motor function in autistic adults following rTMS.
Time frame: Motor function will be assessed at baseline and the day after the final rTMS.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active rTMS to the motor cortex in people with Autism Spectrum Disorder and Motor Activity, run by Centre for Addiction and Mental Health 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 13 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 15 Jun 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pushpal Desarkar, MD (4165358501 ext. 32726, Pushpal.Desarkar@camh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in motor cortical plasticity using motor evoked potentials (MEPs) in autistic adults following rTMS. (time frame: Plasticity in the motor cortex will be evaluated at baseline and the day after the final rTMS session.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jun 2026.