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New treatment option for Autism Spectrum Disorder
Official title rTMS to Improve Motor Function in Autism
ClinicalTrials.gov ID: NCT06497920
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 40. Healthy volunteers may be eligible.
You may be able to join if
- ASD or control participants must meet all of the 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...
You likely can't join if
- 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...
- 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...
See the full eligibility criteria
- ASD or control participants must meet all of the 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...
- 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 \ 1 standard deviation below the mean) on either fine or gross motor composite scores of the Bruininks-Oseretsky Test of Motor...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 40 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.