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

Autism Spectrum Disorder Clinical Trial

Official title:

The Impacts of Theta-burst Stimulation Over Posterior Superior Temporal Sulcus on Children and Adolescents With Autism Spectrum Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03621189
• Other study ID #: 201509413A0
• Status: Completed
• Phase: N/A
• Start date: November 2, 2016
• Est. completion date: April 17, 2019

Study information

• Verified date: August 2018
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 17, 2019
• Est. primary completion date: April 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

Device:
• intermittent theta burst stimulation
stimulatory protocol

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)
Primary	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.	baseline; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)
Secondary	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).	baseline; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)
Secondary	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).	baseline; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)
Secondary	Functional MRI (Biological Motion Task)	The MRI data have to be pre-processed before analysis. It may take few years.	baseline; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline)
Secondary	Resting State fMRI	The MRI data have to be pre-processed before analysis. It may take few years.	baseline; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline)
Secondary	Diffusion Tensor Imaging	The MRI data have to be pre-processed before analysis. It may take few years.	baseline; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline)