Recruiting

rTMS

Sponsor:

Centre for Addiction and Mental Health

Code:

NCT06497920

Conditions

Autism Spectrum Disorder

Motor Activity

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

Interventions

Active rTMS to the motor cortex

Sham rTMS to the motor cortex

Study Details

Brief 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 reduced hyperplasticity in the motor cortex will be associated with clinical improvements in the motor function.

Conditions

Autism Spectrum Disorder

Motor Activity

Study ID

NCT06497920

Start date

Apr 24, 2024

Status verified date

Jun, 2026

Completion date

Jun 30, 2029

Anticipated

Primary completion date

Apr 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

Inclusion Criteria:

ASD or control participants must meet all of the inclusion criteria to eligible for this study:

1. 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;
2. Have IQ>70;
3. Are able to read, write and communicate effectively in English;
4. 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.
5. Have no prior history of seizure;
6. Must sign and date the informed consent form;
7. Stated willingness to comply with all study procedures;
8. 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:

1. Will have DSM-5 diagnosis of ASD without intellectual disability, confirmed by clinical assessment and the Autism Diagnostic Observation Schedule - 2 (ADOS-2);
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;
3. 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.

Exclusion Criteria:

ASD or control participants will be excluded if they experience/have:

1. Current pregnancy;
2. Current or past history of co-morbid medical condition that may require urgent medical intervention;
3. 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;
4. Significant hearing or visual impairment interfering with the ability to read or hear instructions;
5. 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);
6. Metal implants or a pace-maker;
7. 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:

1. Presence of psychopathology other than specific phobia, as screened by Personality Assessment Inventory and;
2. A known diagnosis of Pervasive Developmental Disorder or ASD among any biologically related family members.

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Active rTMS

Autistic adults receiving active rTMS to the motor cortex.

sham comparator: Sham rTMS

Autistic adults receiving sham rTMS to the motor cortex.

Interventions

Active rTMS to the motor cortex

Active bilateral repetitive transcranial magnetic stimulation to the motor cortex

Sham rTMS to the motor cortex

Sham bilateral repetitive transcranial magnetic stimulation to the motor cortex

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. ]

Central Contacts and Locations

Central contacts

Locations

Center for Addiction and Mental Health (CAMH)

Recruiting

Toronto, Ontario, Canada, M6J 1H4

Contacts

More Information

Sponsor

Centre for Addiction and Mental Health

Last update posted

Jun 15, 2026

Last verified

Jun, 2026

Keywords

  • Autism
  • Motor Function
  • Repetitive Transcranial Magnetic Stimulation
  • Transcranial Magnetic Stimulation
  • Motor Cortex
  • Electroencephalography

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Centre for Addiction and Mental Health on 2026-06-15.