rTMS to Improve Motor Function in Autism

Launched by CENTRE FOR ADDICTION AND MENTAL HEALTH · Jul 5, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how a treatment called repetitive Transcranial Magnetic Stimulation (rTMS) can help improve motor function in adults with Autism Spectrum Disorder (ASD). Researchers believe that some motor difficulties in autistic adults may be linked to changes in the brain's motor cortex, and they want to see if rTMS can help reduce these issues. The trial aims to enroll adults aged 18 to 40 who have been diagnosed with ASD and experience significant motor function challenges.

To participate, individuals must be able to communicate effectively in English, have a certain level of intellectual ability, and have no history of seizures. Participants will undergo assessments to confirm their eligibility and will need to agree to follow the study's guidelines. Throughout the trial, participants can expect to receive rTMS treatment and undergo evaluations to see if their motor skills improve. It’s important to know that those with certain medical conditions, past rTMS treatments, or significant hearing or visual impairments may not be eligible to join the study.

Gender

ALL

Eligibility criteria

• 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 WAIS. 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 throughout study duration.
• 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;
• • 8. Claustrophobia;
• • 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.