Status:
RECRUITING
rTMS to Improve Motor Function in Autism
Lead Sponsor:
Centre for Addiction and Mental Health
Conditions:
Autism Spectrum Disorder
Motor Activity
Eligibility:
All Genders
18-40 years
Phase:
NA
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...
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 experien...
Eligibility Criteria
Inclusion
- 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;
- 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.
Exclusion
- 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);
- 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.
Key Trial Info
Start Date :
April 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2029
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06497920
Start Date
April 24 2024
End Date
June 30 2029
Last Update
November 14 2025
Active Locations (1)
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1
Center for Addiction and Mental Health (CAMH)
Toronto, Ontario, Canada, M6J 1H4