Explore the Impacts of One Session Theta Burst Stimulation Over Cerebellum in Adults With Autism Spectrum Disorder
Not Applicable
Active, not recruiting
- Conditions
- Autism Spectrum Disorder
- Interventions
- Device: intermittent theta burst stimulation
- Registration Number
- NCT05578261
- Lead Sponsor
- Chang Gung Memorial Hospital
- Brief Summary
The investigator would like to investigate the impact of theta-burst stimulation over cerebellum in adults with autism spectrum disorder
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 10
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Active intermittent theta burst stimulation 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.
- Primary Outcome Measures
Name Time Method Adverse effects report form (Tinnitus) 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 (Headache) 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 (Dizziness) 1 week after iTBS (post iTBS) Recording adverse effects in participants after iTBS.
- Secondary Outcome Measures
Name Time Method MRI T1 Within one month Brain structural volumes (cm²)
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.
Trial Locations
- Locations (1)
Chang Gung Memorial Hospital
🇨🇳Taoyuan, Taiwan