Explore the Impacts of One Session Theta Burst Stimulation Over Cerebellum in Adults With Autism Spectrum Disorder

Study Overview
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Brief Summary
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The investigator would like to investigate the impact of theta-burst stimulation over cerebellum in adults with autism spectrum disorder

Official Title
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Explore the Impacts of One Session Theta Burst Stimulation Over Cerebellum in Adults With Autism Spectrum Disorder

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Device: intermittent theta burst stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults with autism spectrum disorder (≥18 years old), confirmed by Autism Diagnostic Observation Schedule. Exclusion Criteria: Previous or current severe neurological disorder such as epilepsy, visual or hearing impairment. Previous or current severe systemic disease such as cardiovascular disease, diabetes or infection. Previous or current severe brain injury Implementation of metal materials such as pacemaker or medication pump Previous or current severe psychiatric disorders such as schizophrenia, bipolar disorder or substance abuse Pregnancy Individuals with a significant brain abnormality such as intracranial space occupied lesions History of brain surgery or nervous system infection, such as meningitis and encephalitis Concurrent use of medications which increased the risk of seizure attack Participate another clinical trial within one month Skin trauma on application site Individuals suffering from multiple sclerosis Individuals with a large ischemic scar Individuals suffering from sleep deprivation during rTMS procedures Individuals with a heavy consumption of alcohol Current taking antiepileptic drugs Individuals with a migraine headache from increased intracranial pressure Unable to complete MRI scan Withdrawal criteria: Seizure attack during study period Autistic symptoms worsened obviously during study period Extreme agitation or irritability during study period Participants request Take antiepileptic drug during study period

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>All of the participants will accept one session iTBS over right Crus I/II. The total pulses of every session are 1200 pulses (600 pulses with 15 minutes interval) *iTBS = intermittent theta burst stimulation. | Device: intermittent theta burst stimulation<br>* stimulatory protocol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse effects report form (Headache) | Recording adverse effects in participants after iTBS. | 1 week after iTBS (post iTBS) | 
| Adverse effects report form (Dizziness) | Recording adverse effects in participants after iTBS. | 1 week after iTBS (post iTBS) | 
| Adverse effects report form (Tinnitus) | Recording adverse effects in participants after iTBS. | 1 week after iTBS (post iTBS) | 
| Adverse effects report form (Seizure) | Recording adverse effects in participants after iTBS. | 1 week after iTBS (post iTBS) | 
| Adverse effects report form (Other) | Recording adverse effects in participants after iTBS. | 1 week after iTBS (post iTBS) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI T1 | Brain structural volumes (cm²) | Within one month | 
| functional MRI (resting-state/biological motion task) - BOLD signal | Blood-oxygen-level-dependent (BOLD) signal is a measurement used in fMRI, which reflects the neural activity. | Within one month |