rTMS to Improve Motor Function in Autism (NCT06497920) | Clinical Trial Compass
RecruitingNot Applicable
rTMS to Improve Motor Function in Autism
Canada150 participantsStarted 2024-04-24
Plain-language 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.
Who can participate
Age range
18 Years – 40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in motor cortical plasticity using motor evoked potentials (MEPs) in autistic adults following rTMS.
Timeframe: Plasticity in the motor cortex will be evaluated at baseline and the day after the final rTMS session.
. Agreement to adhere to Lifestyle Considerations, that is: refrain from consumption of alcohol, tobacco, marijuana, or caffeine on the day of study visits.
Exclusion criteria
. 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;
. Presence of psychopathology other than specific phobia, as screened by Personality Assessment Inventory and;