The Therapeutic Effect of TBS Stimulation on Emotion Regulation in Autism Spectrum Disorder
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Active Participants received the real intervention of TBS (iTBS 1200) over the left dorsolateral prefrontal cortex for 4 weeks (5 days/week). *iTBS = intermittent theta burst stimulation |
Device: intermittent theta burst stimulation
stimulatory protocol
|
| Sham Comparator: Sham Participants received the sham intervention of TBS (sham-coil) over the left dorsolateral prefrontal cortex for 4 weeks (5 days/week). |
Device: intermittent theta burst stimulation
stimulatory protocol
|
Outcome Measures
Primary Outcome Measures
- 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
- 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 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.
- 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.
- 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.
- 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.
- 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.
- Autism Diagnostic Observation Schedule - Generic [baseline; post TBS (4 weeks after baseline)]
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.
- MRI T1 [baseline; post TBS (4 weeks after baseline)]
Brain structural volumes (cm²)
- 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.
- 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)
Eligibility Criteria
Criteria
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
-
seizure history
-
pregnant
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Chang Gung Memorial Hospital | Taoyuan | Taiwan | 33305 |
Sponsors and Collaborators
- Chang Gung Memorial Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 202002498A0