The Therapeutic Effects of Intermittent Theta Burst Stimulation in Autism Spectrum Disorder

Not Applicable

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

• Registration Number: NCT04987749
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-05
• Study First Submitted: 2021-07-12
• Study First Submitted QC: 2021-08-02
• Study First Posted: 2021-08-03
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-07
• Last Update Posted: 2022-07-08
• Primary Completion: 2023-08
• Study Completion: 2023-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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
Sham	intermittent theta burst stimulation	Participants received the sham intervention of TBS (coil tilted one-wing 90° off the head) over the right inferior frontal gyrus for 8 weeks (2 days/week).
Active	intermittent theta burst stimulation	Participants received the real intervention of TBS (iTBS 600) over the right inferior frontal gyrus for 8 weeks (2 days/week). \*iTBS = intermittent theta burst stimulation

Primary Outcome Measures

Name	Time	Method
Changes of total scores of Social Responsiveness Scale	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	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 Outcome Measures

Name	Time	Method
Changes of total scores of Emotional Dysregulation Inventory	baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)	Emotional Dysregulation Inventory is a parents' report questionnaire for emotional dysregulation. The score ranges from 0-120. The lower scores stand for better emotional regulation.
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)	Behavior Rating Inventory of Executive Function is a parents' report questionnaire for executive function. The score ranges from 75-225. The lower scores stand for better executive function.
MRI T1	baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)	Brain structural volumes (cm²)
Diffusion Tensor Imaging (DTI) - FA	baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)	Fractional anisotropy (FA) is a measurement used in DTI, which reflects the movement of water molecules. FA ranges from 0 to 1, the higher FA value may represent more intact axons.
Changes in accuracy of Frith-Happe animation	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.
Autism Diagnostic Observation Schedule - Generic	baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)	The Autism Diagnostic Observation Schedule is a semi-structured assessment of communication, social interaction, and play (or imaginative use of materials) for individuals suspected of having autism spectrum disorders. The social affect domain includes the social and communication items ranging from 0 to 20. The higher scores stand for more clinical severity of autism spectrum disorder.
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)	Adaptive Behavior Assessment System is a parents' report questionnaire for adaptive behavior. The scores ranges from 9-171. The higher scores stand for better adaptive behavior.
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)	Blood-oxygen-level-dependent (BOLD) signal is a measurement used in fMRI, which reflects the neural activity.
Changes in accuracy of Eyes task	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.
Changes in accuracy of Wisconsin Card Sorting Test	baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)	An advanced test for cognitive flexibility. 128 questions in total, the more correct questions stand for better cognitive flexibility.
Raven's Progressive Matrices	baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)	An advanced test for for executive function. 60 questions in total, the more correct questions stand for better executive function.
Electroencephalography	baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)	Resting state EEG (alpha power / frontal gamma power)

Trial Locations

Locations (1)

Chang Gung Memorial Hospital; 🇨🇳 Taoyuan, Taiwan