Skip to main content
Clinical Trials/NCT04987541
NCT04987541
Recruiting
Not Applicable

The Therapeutic Effect of TBS Stimulation Over Left Dorsolateral Prefrontal Cortex on Emotion Regulation in Autism Spectrum Disorder

Chang Gung Memorial Hospital1 site in 1 country60 target enrollmentSeptember 6, 2022

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 Emotional Dysregulation Inventory
Status
Recruiting
Last Updated
2 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
September 6, 2022
End Date
December 2025
Last Updated
2 years 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 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

Outcomes

Primary Outcomes

Changes of total scores of Emotional Dysregulation Inventory

Time Frame: 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

Time Frame: 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

Time Frame: 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 Outcomes

  • 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))
  • 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))
  • 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))
  • 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))
  • Diffusion Tensor Imaging (DTI) - FA(baseline; post TBS (4 weeks after baseline))
  • Electroencephalography(baseline; post TBS (4 weeks after baseline))
  • 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))
  • 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))
  • 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))
  • MRI T1(baseline; post TBS (4 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 (4 weeks after post TBS); Two months follow up (8 weeks after post TBS))
  • functional MRI (resting-state/biological motion task) - BOLD signal(baseline; post TBS (4 weeks after baseline))

Study Sites (1)

Loading locations...

Similar Trials