(AMBLE Autism)Repetitive Transcranial Magnetic Stimulation for Motor Function in Autism Spectrum Disorder
This study aims to assess whether repetitive transcranial magnetic stimulation can improve motor function and brain plasticity in adults with autism spectrum disorder.
Active rTMS to the motor cortex
+ Sham rTMS to the motor cortex
Autism Spectrum Disorder+4
+ Autistic Disorder
+ Behavior
Treatment Study
Summary
Study start date: April 24, 2024
Actual date on which the first participant was enrolled.This study is focused on helping autistic adults who struggle with motor skills such as balance, posture, coordination, and strength. These motor difficulties can significantly affect their daily lives and social interactions, yet there are currently no effective treatments available. The study aims to explore whether a technique called repetitive transcranial magnetic stimulation (rTMS) can improve motor function by reducing an overactivity in the brain's motor cortex observed in autistic adults. This research is important because it could lead to better treatment options for improving the quality of life for those with autism spectrum disorder. Participants in the study will include 100 autistic adults and 50 neurotypical adults for comparison. Autistic participants will visit the research center nine times, while neurotypical participants will visit twice. During these visits, various assessments of motor skills and brain activity will be conducted, including a technique called TBS and EEG to measure brain plasticity. Autistic participants will be randomly assigned to either receive the active rTMS treatment or a sham treatment over five sessions. This involves applying magnetic pulses to the brain for about an hour each session. The effectiveness of the treatment will be evaluated through follow-up assessments conducted immediately after, one week, and four weeks after the last session. The study seeks to determine if rTMS can effectively improve motor functions in autistic adults.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.150 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 40 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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 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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
Active ComparatorGroup II
ShamStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Center for Addiction and Mental Health (CAMH)
Toronto, CanadaOpen Center for Addiction and Mental Health (CAMH) in Google Maps