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

Not Applicable

Completed

• Conditions: Autism Spectrum Disorder
• Interventions: Device: intermittent theta burst stimulation

• Registration Number: NCT03621189
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-02
• Study First Submitted: 2018-07-07
• Status Verified: 2018-08
• Study First Submitted QC: 2018-08-03
• Study First Posted: 2018-08-08
• Primary Completion: 2019-04-17
• Study Completion: 2019-04-17
• Results First Submitted: 2021-07-12
• Results First Submitted QC: 2021-08-04
• Results First Posted: 2021-08-27
• Last Update Submitted: 2024-01-03
• Last Update Posted: 2024-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active-Active	intermittent theta burst stimulation	Participants received the real intervention of TBS (iTBS 1200) over the posterior superior temporal sulcus for 8 weeks (2 days/week). \*iTBS = intermittent theta burst stimulation
Sham-Active	intermittent theta burst stimulation	Participants received the sham intervention of TBS (coil tilted one-wing 90° off the head) over the posterior superior temporal sulcus for 4 weeks (2 days/week) and then received the real intervention of TBS (iTBS 1200) over the posterior superior temporal sulcus for 4 weeks (2 days/week). \*iTBS = intermittent theta burst stimulation

Primary Outcome Measures

Name	Time	Method
Changes of Total Scores of Repetitive Behavior Scale-Revised	baseline; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)	RBS-R is a questionnaire that focuses on repetitive behavior. The score range from 0-129. The lower scores stand for lower repetitive behavior.
Changes of Total Scores of Social Responsiveness Scale	baseline; during TBS (4 weeks after 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.

Secondary Outcome Measures

Name	Time	Method
Functional MRI (Biological Motion Task)	baseline; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline)	The MRI data have to be pre-processed before analysis. It may take few years.
Changes in Accuracy of Eyes Task	baseline; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)	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).
Changes in Accuracy of Frith-Happe Animation	baseline; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)	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).
Resting State fMRI	baseline; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline)	The MRI data have to be pre-processed before analysis. It may take few years.
Diffusion Tensor Imaging	baseline; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline)	The MRI data have to be pre-processed before analysis. It may take few years.

Trial Locations

Locations (1)

Chang Gung Memorial Hospital; 🇨🇳 Taoyuan, Taiwan