Clinical trial NCT04993144: The Therapeutic Effects of Continuous Theta Burst Stimulation in Autism Spectrum Disorder
Official title: To Explore the Therapeutic Effects of Continuous Theta-burst Stimulation Over Left Dorsolateral Prefrontal Cortex in Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2021-08-06
Enrollment: 90
Sex: ALL
Minimum age (years): 8
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigator would like to investigate the impact of theta burst stimulation over left dorsolateral prefrontal cortex in autism spectrum disorder


Eligibility criteria: Inclusion Criteria:

* autism spectrum disorder, confirmed by ADOS

Exclusion Criteria:

* current and past systemic disease
* current and past major psychiatric disorders including schizophrenia, bipolar affective disorder and major depressive disorder
* current and past brain injuries
* intelligence \< 70
* seizure history
* pregnant

Primary outcomes:
measure: Changes of total scores of Social Responsiveness Scale
timeFrame: baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)
measure: Changes of total scores of Repetitive Behavior Scale-Revised
timeFrame: baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)
Secondary outcomes:
measure: Changes of total scores of Emotional Dysregulation Inventory
timeFrame: baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)
measure: Changes of total scores of Adaptive Behavior Assessment System
timeFrame: baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)
measure: Changes of total scores of Vineland Adaptive Behavior Scales
timeFrame: baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)
measure: Changes in accuracy of Frith-Happe animation
timeFrame: baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)
measure: Changes in accuracy of Eyes task
timeFrame: baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)
measure: Changes in accuracy of Wisconsin Card Sorting Test
timeFrame: baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)
measure: Changes of total scores of Behavior Rating Inventory of Executive Function
timeFrame: baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)
measure: Raven's Progressive Matrices
timeFrame: baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)
measure: Autism Diagnostic Observation Schedule - Generic
timeFrame: baseline; post TBS (8 weeks after baseline)
measure: MRI T1
timeFrame: baseline; post TBS (8 weeks after baseline)
measure: functional MRI (resting-state/biological motion task) - BOLD signal
timeFrame: baseline; post TBS (8 weeks after baseline)
measure: Diffusion Tensor Imaging (DTI) - FA
timeFrame: baseline; post TBS (8 weeks after baseline)
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
References: