Autism Spectrum Disorder
Conditions
Brief summary
The investigator would like to investigate the impact of theta-burst stimulation over cerebellum in adults with autism spectrum disorder
Interventions
DEVICEintermittent theta burst stimulation
stimulatory protocol
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse effects report form (Dizziness) | 1 week after iTBS (post iTBS) | Recording adverse effects in participants after iTBS. |
| Adverse effects report form (Seizure) | 1 week after iTBS (post iTBS) | Recording adverse effects in participants after iTBS. |
| Adverse effects report form (Other) | 1 week after iTBS (post iTBS) | Recording adverse effects in participants after iTBS. |
| Adverse effects report form (Headache) | 1 week after iTBS (post iTBS) | Recording adverse effects in participants after iTBS. |
| Adverse effects report form (Tinnitus) | 1 week after iTBS (post iTBS) | Recording adverse effects in participants after iTBS. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| functional MRI (resting-state/biological motion task) - BOLD signal | Within one month | Blood-oxygen-level-dependent (BOLD) signal is a measurement used in fMRI, which reflects the neural activity. |
| MRI T1 | Within one month | Brain structural volumes (cm²) |
Countries
Taiwan
Outcome results
None listed