The Impacts of Theta-burst Stimulation on Children and Adolescents With Autism Spectrum Disorder

Chang Gung Memorial Hospital80 enrolled

Overview

The investigator would like to investigate the impact of theta-burst stimulation over posterior superior temporal sulcus in children and adolescents with 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: 7 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Chang Gung Memorial Hospital

Taoyuan, Taiwan

Outcomes

Primary 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; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)

Changes of Total Scores of Repetitive Behavior Scale-Revised

RBS-R is a questionnaire that focuses on repetitive behavior. The score range from 0-129. The lower scores stand for lower repetitive behavior.

Time frame: baseline; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)

Secondary Outcomes

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 (The score ranges from 0-48).

Time frame: baseline; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline); One month follow up (4 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 (The score ranges from 0-43).

Time frame: baseline; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)

Functional MRI (Biological Motion Task)

The MRI data have to be pre-processed before analysis. It may take few years.

Time frame: baseline; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline)

Resting State fMRI

Data from ClinicalTrials.gov

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