The Therapeutic Effect of TBS Stimulation on Emotion Regulation in Autism Spectrum Disorder

Autism Spectrum Disorder Clinical Trial

Official title:

The Therapeutic Effect of TBS Stimulation Over Left Dorsolateral Prefrontal Cortex on Emotion Regulation in Autism Spectrum Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04987541
• Other study ID #: 202002498A0
• Status: Recruiting
• Phase: N/A
• Start date: September 6, 2022
• Est. completion date: December 2025

Study information

• Verified date: August 2023
• Source: Chang Gung Memorial Hospital
• Contact: Hsing-Chang Ni, Dr.
• Phone: 88633281200
• Email: alanni0918[@]yahoo.com.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

Device:
• intermittent theta burst stimulation
stimulatory protocol

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of total scores of Emotional Dysregulation Inventory	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.	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)
Primary	Changes of total scores of Aberrant Behavior Checklist	ABC is a parents' report questionnaire for aberrant behavior. The lower scores stand for less aberrant behavior.	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)
Primary	Changes of total scores of Child Behavior Checklist	CBCL is a parents' report questionnaire for behavioral and emotional problems. The lower scores stand for better behavioral and emotional regulation.	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	Changes of total scores of Social Responsiveness Scale	Social Responsiveness Scale can measure the autism clinical severity with the range from 65-260. The lower scores stand for better social responsiveness.	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	Changes of total scores of Repetitive Behavior Scale-Revised	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.	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	Changes of total scores of Adaptive Behavior Assessment System	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.	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	Changes in accuracy of Frith-Happe animation	A quick and objective test of Theory of Mind. 8 questions in total, the more correct questions stand for better Social Cognition.	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	Changes in accuracy of Eyes task	An advanced test for Theory of Mind. 43 questions in total, the more correct questions stand for better social skills.	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	Changes in accuracy of Wisconsin Card Sorting Test	An advanced test for cognitive flexibility. 128 questions in total, the more correct questions stand for better cognitive flexibility.	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	Changes of total scores of Behavior Rating Inventory of Executive Function	Behavior Rating Inventory of Executive Function is a parents' report questionnaire for executive function. The score ranges from 86-258. The lower scores stand for better executive function.	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	Raven's Progressive Matrices	An advanced test for for executive function. 60 questions in total, the more correct questions stand for better executive function.	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	MRI T1	Brain structural volumes (cm²)	baseline; post TBS (4 weeks after baseline)
Secondary	functional MRI (resting-state/biological motion task) - BOLD signal	Blood-oxygen-level-dependent (BOLD) signal is a measurement used in fMRI, which reflects the neural activity.	baseline; post TBS (4 weeks after baseline)
Secondary	Diffusion Tensor Imaging (DTI) - FA	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.	baseline; post TBS (4 weeks after baseline)
Secondary	Electroencephalography	Resting state EEG (alpha power / frontal gamma power)	baseline; post TBS (4 weeks after baseline)