Using rTMS to enhance motor function in autistic adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This project aims to investigate the role of hyperplasticity in the motor cortex as a contributor to motor function difficulties in autistic adults. The study will utilize repetitive Transcranial Magnetic Stimulation (rTMS) to assess whether reducing hyperplasticity can lead to improvements in motor function. A total of 100 autistic adults with significant motor challenges and 50 neurotypical controls will participate in clinical and motor function assessments over multiple visits. The study will compare the effects of active rTMS versus sham rTMS on motor performance.

Why it matters

Who can join: the full rules

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.

Where it's running

• Center for Addiction and Mental Health (CAMH)
  Toronto, Ontario, Canada Recruiting

Study contacts

• Study coordinator: Pushpal Desarkar, MD
• Email: Pushpal.Desarkar@camh.ca
• Phone: 4165358501

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.