rTMS to Improve Motor Function in Autism

Last updated: November 13, 2025
Sponsor: Centre for Addiction and Mental Health
Overall Status: Active - Recruiting

Phase

N/A

Condition

Autism Spectrum Disorder (Asd)

Autism

Asperger's Disorder

Treatment

Sham rTMS to the motor cortex

Active rTMS to the motor cortex

Clinical Study ID

NCT06497920
2023/180
  • Ages 18-40
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 thereport 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-ableautistic adults. The intellectual ability will be determined using WASI-II. Theability 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 consumptionof 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 byclinical assessment and the Autism Diagnostic Observation Schedule - 2 (ADOS-2);

  2. Will have significant motor function difficulties defined as a standard compositescore <40 (i.e., >1 standard deviation below the mean) on either fine or gross motorcomposite scores of the Bruininks-Oseretsky Test of Motor Proficiency, SecondEdition or BOT-2;

  3. Are clinically stable as determined by clinical assessment, with no medicationchanges over the past 4 weeks. Given the high variability of handedness in ASD, wewill include participants with left, right or mixed handedness.

Exclusion

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 urgentmedical 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 hoursprior to the iTBS session;

  4. Significant hearing or visual impairment interfering with the ability to read orhear instructions;

  5. Significantly debilitating medical or neurologic illness (e.g., encephalitis,aneurysms, tumors, central nervous system infections), or acute or unstable medicalillnesses 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 PersonalityAssessment Inventory and;

  2. A known diagnosis of Pervasive Developmental Disorder or ASD among any biologicallyrelated family members.

Study Design

Total Participants: 150
Treatment Group(s): 2
Primary Treatment: Sham rTMS to the motor cortex
Phase:
Study Start date:
April 24, 2024
Estimated Completion Date:
June 30, 2029

Study 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 eight 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, one week (seventh visit), and four weeks (eighth visit) after the last rTMS session (i.e. 3rd rTMS session).

Connect with a study center

  • Center for Addiction and Mental Health (CAMH)

    Toronto, Ontario M6J 1H4
    Canada

    Site Not Available

  • Center for Addiction and Mental Health (CAMH)

    Toronto 6167865, Ontario 6093943 M6J 1H4
    Canada

    Active - Recruiting

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