Using rTMS to enhance motor function in autistic adults

Modulating Plasticity in the Motor Cortex Using Repetitive Transcranial Magnetic Stimulation to Improve Motor Function in Autism Spectrum Disorder

This study is testing if a brain treatment called rTMS can help improve motor skills in autistic adults who have trouble with movement.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years to 40 Years
• Sex: All
• Sponsor: Centre for Addiction and Mental Health (other)
• Locations: 1 site (Toronto, Ontario)
• Trial ID: NCT06497920 on ClinicalTrials.gov

What this trial studies

This project aims to investigate the role of hyperplasticity in the motor cortex as a contributor to motor function difficulties in autistic adults. The study will utilize repetitive Transcranial Magnetic Stimulation (rTMS) to assess whether reducing hyperplasticity can lead to improvements in motor function. A total of 100 autistic adults with significant motor challenges and 50 neurotypical controls will participate in clinical and motor function assessments over multiple visits. The study will compare the effects of active rTMS versus sham rTMS on motor performance.

Who should consider this trial

Good fit: Ideal candidates are autistic adults aged 18 to 40 with significant motor function difficulties and an IQ above 70.

Not a fit: Patients with a history of seizures or those who do not meet the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve motor function and quality of life for autistic adults.

How similar studies have performed: While the use of rTMS in this context is relatively novel, previous studies have shown promising results in reducing hyperplasticity in the motor cortex.

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 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.

Where this trial is running

Toronto, Ontario

• Center for Addiction and Mental Health (CAMH) — Toronto, Ontario, Canada (RECRUITING)

Study contacts

• Study coordinator: Pushpal Desarkar, MD

Conditions: Autism Spectrum Disorder, Motor Activity, Autism, Motor Function, Repetitive Transcranial Magnetic Stimulation, Transcranial Magnetic Stimulation, Motor Cortex, Electroencephalography