To Explore the Therapeutic Effects of Theta Burst Stimulation Over Right Inferior Frontal Gyrus in Autism Spectrum Disorder

Chang Gung Memorial Hospital1 site in 1 country60 target enrollmentNovember 5, 2019

ConditionsAutism Spectrum Disorder

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Autism Spectrum Disorder
Sponsor: Chang Gung Memorial Hospital
Enrollment: 60
Locations: 1
Primary Endpoint: Changes of total scores of Social Responsiveness Scale
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The investigator would like to investigate the impact of theta burst stimulation over right inferior frontal gyrus in autism spectrum disorder

Registry

clinicaltrials.gov

Start Date

November 5, 2019

End Date

November 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Chang Gung Memorial Hospital

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

Changes of total scores of Social Responsiveness Scale

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

Social Responsiveness Scale can measure the autism clinical severity with the range from 65-260. The lower scores stand for better social responsiveness.

Changes of total scores of Repetitive Behavior Scale-Revised

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

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.

Secondary Outcomes

Changes of total scores of Emotional Dysregulation Inventory(baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS))
Changes of total scores of Behavior Rating Inventory of Executive Function(baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS))
MRI T1(baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS))
Diffusion Tensor Imaging (DTI) - FA(baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS))
Changes in accuracy of Frith-Happe animation(baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS))
Autism Diagnostic Observation Schedule - Generic(baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS))
Changes of total scores of Adaptive Behavior Assessment System(baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS))
functional MRI (resting-state/biological motion task) - BOLD signal(baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS))
Changes in accuracy of Eyes task(baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS))
Changes in accuracy of Wisconsin Card Sorting Test(baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS))
Raven's Progressive Matrices(baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS))
Electroencephalography(baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS))