search
Back to results

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

Primary Purpose

Autism Spectrum Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
intermittent theta burst stimulation
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder

Eligibility Criteria

8 Years - 30 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Chang Gung Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active

Sham

Arm Description

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

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).

Outcomes

Primary Outcome Measures

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.
Changes of total scores of Repetitive Behavior Scale-Revised
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

Changes of total scores of Emotional Dysregulation Inventory
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 Adaptive Behavior Assessment System
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.
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.
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.
Changes in accuracy of Wisconsin Card Sorting Test
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
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.
Raven's Progressive Matrices
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
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
Brain structural volumes (cm²)
functional MRI (resting-state/biological motion task) - BOLD signal
Blood-oxygen-level-dependent (BOLD) signal is a measurement used in fMRI, which reflects the neural activity.
Diffusion Tensor Imaging (DTI) - FA
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
Resting state EEG (alpha power / frontal gamma power)

Full Information

First Posted
July 12, 2021
Last Updated
July 7, 2022
Sponsor
Chang Gung Memorial Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04987749
Brief Title
The Therapeutic Effects of Intermittent Theta Burst Stimulation in Autism Spectrum Disorder
Official Title
To Explore the Therapeutic Effects of Theta Burst Stimulation Over Right Inferior Frontal Gyrus in Autism Spectrum Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 5, 2019 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Active Comparator
Arm Description
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
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
intermittent theta burst stimulation
Intervention Description
stimulatory protocol
Primary Outcome Measure Information:
Title
Changes of total scores of Social Responsiveness Scale
Description
Social Responsiveness Scale can measure the autism clinical severity with the range from 65-260. The lower scores stand for better social responsiveness.
Time Frame
baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)
Title
Changes of total scores of Repetitive Behavior Scale-Revised
Description
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.
Time Frame
baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)
Secondary Outcome Measure Information:
Title
Changes of total scores of Emotional Dysregulation Inventory
Description
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.
Time Frame
baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)
Title
Changes of total scores of Adaptive Behavior Assessment System
Description
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.
Time Frame
baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)
Title
Changes in accuracy of Frith-Happe animation
Description
A quick and objective test of Theory of Mind. 8 questions in total, the more correct questions stand for better Social Cognition.
Time Frame
baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)
Title
Changes in accuracy of Eyes task
Description
An advanced test for Theory of Mind. 43 questions in total, the more correct questions stand for better social skills.
Time Frame
baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)
Title
Changes in accuracy of Wisconsin Card Sorting Test
Description
An advanced test for cognitive flexibility. 128 questions in total, the more correct questions stand for better cognitive flexibility.
Time Frame
baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)
Title
Changes of total scores of Behavior Rating Inventory of Executive Function
Description
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.
Time Frame
baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)
Title
Raven's Progressive Matrices
Description
An advanced test for for executive function. 60 questions in total, the more correct questions stand for better executive function.
Time Frame
baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)
Title
Autism Diagnostic Observation Schedule - Generic
Description
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.
Time Frame
baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)
Title
MRI T1
Description
Brain structural volumes (cm²)
Time Frame
baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)
Title
functional MRI (resting-state/biological motion task) - BOLD signal
Description
Blood-oxygen-level-dependent (BOLD) signal is a measurement used in fMRI, which reflects the neural activity.
Time Frame
baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)
Title
Diffusion Tensor Imaging (DTI) - FA
Description
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.
Time Frame
baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)
Title
Electroencephalography
Description
Resting state EEG (alpha power / frontal gamma power)
Time Frame
baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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 intelligence < 70 seizure history pregnant
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hsing-Chang Ni
Phone
88633281200
Ext
3815
Email
alanni0918@yahoo.com.tw
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Taoyuan
ZIP/Postal Code
33305
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hsing-Chang Ni, Dr
Phone
88633281200
Ext
3815
Email
alanni0918@yahoo.com.tw

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs