The Therapeutic Effect of TBS Stimulation on Emotion Regulation in Autism Spectrum Disorder

Not Applicable

Recruiting

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

• Registration Number: NCT04987541
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

The investigator would like to investigate the impact of intermittent theta burst stimulation over left dorsolateral prefrontal cortex on emotion regulation in autism spectrum disorder

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-12
• Study First Submitted QC: 2021-08-02
• Study First Posted: 2021-08-03
• Study Start: 2022-09-06
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-29
• Last Update Posted: 2023-08-31
• Primary Completion: 2025-09
• Study Completion: 2025-12

Recruitment & Eligibility

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

Inclusion Criteria

• autism spectrum disorder, confirmed by ADOS

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
• Individuals with a family history of epilepsy
• Previous febrile seizures
• Current taking antiepileptic drugs
• Concurrent use of medications which increased the risk of seizure attack
• Individuals suffering from sleep deprivation during rTMS procedures
• Skin trauma on application site
• Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to participate in the study
• Participate another clinical trial within one month

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active	intermittent theta burst stimulation	Participants received the real intervention of TBS (iTBS 600) over the left dorsolateral prefrontal cortex for 4 weeks (5 days/week). \*iTBS = intermittent theta burst stimulation
Sham	intermittent theta burst stimulation	Participants received the sham intervention of TBS (sham-coil) over the left dorsolateral prefrontal cortex for 4 weeks (5 days/week).

Primary Outcome Measures

Name	Time	Method
Changes of total scores of Emotional Dysregulation Inventory	baseline; post TBS (4 weeks after baseline); One month follow up (4 weeks after post TBS); Two months follow up (8 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 Aberrant Behavior Checklist	baseline; post TBS (4 weeks after baseline); One month follow up (4 weeks after post TBS); Two months follow up (8 weeks after post TBS)	ABC is a parents' report questionnaire for aberrant behavior. The lower scores stand for less aberrant behavior.
Changes of total scores of Child Behavior Checklist	baseline; post TBS (4 weeks after baseline); One month follow up (4 weeks after post TBS); Two months follow up (8 weeks after post TBS)	CBCL is a parents' report questionnaire for behavioral and emotional problems. The lower scores stand for better behavioral and emotional regulation.

Secondary Outcome Measures

Name	Time	Method
Changes in accuracy of Eyes task	baseline; post TBS (4 weeks after baseline); One month follow up (4 weeks after post TBS); Two months follow up (8 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 (4 weeks after baseline); One month follow up (4 weeks after post TBS); Two months follow up (8 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 (4 weeks after baseline); One month follow up (4 weeks after post TBS); Two months follow up (8 weeks after post TBS)	An advanced test for for executive function. 60 questions in total, the more correct questions stand for better executive function.
Changes of total scores of Adaptive Behavior Assessment System	baseline; post TBS (4 weeks after baseline); One month follow up (4 weeks after post TBS); Two months follow up (8 weeks after post TBS)	Adaptive Behavior Assessment System is a parents' report questionnaire for adaptive behavior. The score ranges from 9-171. The higher scores stand for better adaptive behavior.
Diffusion Tensor Imaging (DTI) - FA	baseline; post TBS (4 weeks after baseline)	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.
Electroencephalography	baseline; post TBS (4 weeks after baseline)	Resting state EEG (alpha power / frontal gamma power)
Changes of total scores of Social Responsiveness Scale	baseline; post TBS (4 weeks after baseline); One month follow up (4 weeks after post TBS); Two months follow up (8 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 (4 weeks after baseline); One month follow up (4 weeks after post TBS); Two months follow up (8 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.
Changes in accuracy of Frith-Happe animation	baseline; post TBS (4 weeks after baseline); One month follow up (4 weeks after post TBS); Two months follow up (8 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.
MRI T1	baseline; post TBS (4 weeks after baseline)	Brain structural volumes (cm²)
Changes of total scores of Behavior Rating Inventory of Executive Function	baseline; post TBS (4 weeks after baseline); One month follow up (4 weeks after post TBS); Two months follow up (8 weeks after post TBS)	Behavior Rating Inventory of Executive Function is a parents' report questionnaire for executive function. The score ranges from 86-258. The lower scores stand for better executive function.
functional MRI (resting-state/biological motion task) - BOLD signal	baseline; post TBS (4 weeks after baseline)	Blood-oxygen-level-dependent (BOLD) signal is a measurement used in fMRI, which reflects the neural activity.

Trial Locations

Locations (1)

Chang Gung Memorial Hospital; 🇨🇳 Taoyuan, Taiwan