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

Chang Gung Memorial Hospital60 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Autism Spectrum Disorder

Interventions

intermittent theta burst stimulationDEVICE

stimulatory protocol

Eligibility

Sex: ALLMin age: 8 YearsMax age: 30 Years

Medical Language ↔ Plain English

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

Locations (1)

Chang Gung Memorial Hospital

Taoyuan, Taiwan

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 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)

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.

Time frame: 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)

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.

Time frame: 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

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.

Time frame: 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)

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.

Time frame: 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)

Central Contacts

Hsing-Chang Ni, Dr.

CONTACT

88633281200 alanni0918@yahoo.com.tw

Data from ClinicalTrials.gov

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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.

Time frame: 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)

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.

Time frame: 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)

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.

Time frame: 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)

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.

Time frame: 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)

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.

Time frame: 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)

Raven's Progressive Matrices

An advanced test for for executive function. 60 questions in total, the more correct questions stand for better executive function.

Time frame: 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)

MRI T1

Brain structural volumes (cm²)

Time frame: baseline; post TBS (4 weeks after baseline)

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.

Time frame: baseline; post TBS (4 weeks after baseline)

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.

Time frame: baseline; post TBS (4 weeks after baseline)

Electroencephalography

Resting state EEG (alpha power / frontal gamma power)

Time frame: baseline; post TBS (4 weeks after baseline)