Clinical trial NCT04987541: The Therapeutic Effect of TBS Stimulation on Emotion Regulation in Autism Spectrum Disorder
Official title: The Therapeutic Effect of TBS Stimulation Over Left Dorsolateral Prefrontal Cortex on Emotion Regulation in Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2021-08-03
Enrollment: 60
Sex: ALL
Minimum age (years): 8
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* autism spectrum disorder, confirmed by ADOS

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
* Individuals with a family history of epilepsy
* Previous febrile seizures
* Current taking antiepileptic drugs
* Concurrent use of medications which increased the risk of seizure attack
* Individuals suffering from sleep deprivation during rTMS procedures
* Skin trauma on application site
* Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to participate in the study
* Participate another clinical trial within one month

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