Therapeutic Impacts of Theta Burst Stimulation Over Bilateral Posterior Superior Temporal Sulcus in Autism Spectrum Disorder: a Comprehensive Study Integrating Clinical Symptoms, Neuropsychological Function and MRI

Chang Gung Memorial Hospital1 site in 1 country60 target enrollmentFebruary 3, 2023

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
Status: Active, not recruiting
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The investigator would like to investigate the impact of intermittent theta burst stimulation over bilateral posterior superior temporal sulcus in autism spectrum disorder

Registry

clinicaltrials.gov

Start Date

February 3, 2023

End Date

December 2025

Last Updated

11 months 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 Autism Diagnostic Observation Schedule II (CSS≧6)
•No change in psychiatric drugs within one month

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
•History of brain surgery or nervous system infection, such as meningitis and encephalitis
•Previous febrile seizures
•Concurrent use of medications which increased the risk of seizure attack.

Outcomes

Primary Outcomes

Changes of total scores of Social Responsiveness Scale

Time Frame: baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline)

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 (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline)

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 (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline))
Changes of total scores of Aberrant Behavior Checklist(baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline))
Changes of total scores of Child Behavior Checklist(baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline))
Changes of total scores of Adaptive Behavior Assessment System(baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline))
Changes in accuracy of Frith-Happe animation(baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline))
Changes of total scores of Behavior Rating Inventory of Executive Function(baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline))
Raven's Progressive Matrices(baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline))
Changes in accuracy of Eyes task(baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline))
Changes in accuracy of Wisconsin Card Sorting Test(baseline; post TBS (4 weeks after baseline); One month follow up (8 weeks after baseline); Two months follow up (12 weeks after baseline))
functional MRI (resting-state/biological motion task) - BOLD signal(baseline; post TBS (4 weeks after baseline))
MRI T1(baseline; post TBS (4 weeks after baseline))
Diffusion Tensor Imaging (DTI) - FA(baseline; post TBS (4 weeks after baseline))
Electroencephalography(baseline; post TBS (4 weeks after baseline))