Therapeutic Impacts of Theta Burst Stimulation Over Bilateral Posterior Superior Temporal Sulcus in Autism Spectrum Disorder
- Conditions
- Autism Spectrum Disorder
- Interventions
- Device: intermittent theta burst stimulation
- Registration Number
- NCT05578209
- Lead Sponsor
- Chang Gung Memorial Hospital
- Brief Summary
The investigator would like to investigate the impact of intermittent theta burst stimulation over bilateral posterior superior temporal sulcus in autism spectrum disorder
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- Autism spectrum disorder, confirmed by Autism Diagnostic Observation Schedule II (CSS≧6)
- No change in psychiatric drugs within one month
- 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
- Previous febrile seizures
- Concurrent use of medications which increased the risk of seizure attack.
- Participate another clinical trial within one month.
- Unable to complete MRI scan (claustrophobia)
- Skin trauma on application site
- Individuals with a large ischemic scar
- Individuals suffering from multiple sclerosis
- Individuals suffering from sleep deprivation during rTMS procedures
- Individuals with a heavy consumption of alcohol
- Individuals with a migraine headache from increased intracranial pressure
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active intermittent theta burst stimulation Participants received the intervention of iTBS (The total pulse of every session is 1200 pulses) over bilateral posterior superior temporal sulcus for 4 weeks (5 days/week). \*iTBS = intermittent theta burst stimulation Sham intermittent theta burst stimulation Participants received the sham intervention of iTBS (sham-coil) over bilateral posterior superior temporal sulcus for 4 weeks (5 days/week).
- Primary Outcome Measures
Name Time Method Changes of total scores of Social Responsiveness Scale baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline) Social Responsiveness Scale can measure the autism clinical severity with the range from 65-260. The lower scores stand for better social responsiveness.
Changes of total scores of Repetitive Behavior Scale-Revised baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline) Repetitive Behavior Scale-Revised is a questionnaire that focuses on repetitive behavior. The score ranges from 0-129. The lower scores stand for lower repetitive behavior.
- Secondary Outcome Measures
Name Time Method Changes of total scores of Emotional Dysregulation Inventory baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline) Emotional Dysregulation Inventory is a parents' report questionnaire for emotional dysregulation. The score ranges from 0-120. The lower scores stand for better emotional regulation.
Changes of total scores of Aberrant Behavior Checklist baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline) ABC is a parents' report questionnaire for aberrant behavior. The lower scores stand for less aberrant behavior.
Changes of total scores of Child Behavior Checklist baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline) CBCL is a parents' report questionnaire for behavioral and emotional problems. The lower scores stand for better behavioral and emotional regulation.
Changes of total scores of Adaptive Behavior Assessment System baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline) Adaptive Behavior Assessment System is a parents' report questionnaire for adaptive behavior. The score ranges from 9-171. The higher scores stand for better adaptive behavior.
Changes in accuracy of Frith-Happe animation baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline) A quick and objective test of Theory of Mind. 8 questions in total, the more correct questions stand for better Social Cognition.
Changes of total scores of Behavior Rating Inventory of Executive Function baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline) An advanced test for cognitive flexibility. 128 questions in total, the more correct questions stand for better cognitive flexibility.
Raven's Progressive Matrices baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline) An advanced test for for executive function. 60 questions in total, the more correct questions stand for better executive function.
Changes in accuracy of Eyes task baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline) An advanced test for Theory of Mind. 43 questions in total, the more correct questions stand for better social skills.
Changes in accuracy of Wisconsin Card Sorting Test baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline) An advanced test for cognitive flexibility. 128 questions in total, the more correct questions stand for better cognitive flexibility.
functional MRI (resting-state/biological motion task) - BOLD signal baseline; post TBS (4 weeks after baseline) Blood-oxygen-level-dependent (BOLD) signal is a measurement used in fMRI, which reflects the neural activity.
MRI T1 baseline; post TBS (4 weeks after baseline) Brain structural volumes (cm²)
Diffusion Tensor Imaging (DTI) - FA baseline; post TBS (4 weeks after baseline) Fractional anisotropy (FA) is a measurement used in DTI, which reflects the movement of water molecules. FA ranges from 0 to 1, the higher FA value may represent more intact axons.
Electroencephalography baseline; post TBS (4 weeks after baseline) Resting state EEG (alpha power / frontal gamma power)
Trial Locations
- Locations (1)
Chang Gung Memorial Hospital
🇨🇳Taoyuan, Taiwan