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The Impacts of Theta-burst Stimulation on Children and Adolescents With Autism Spectrum Disorder

Primary Purpose

Autism Spectrum Disorder

Status
Completed
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

7 Years - 18 Years (Child, Adult)All SexesDoes not accept 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 Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active-Active

Sham-Active

Arm Description

Participants received the real intervention of TBS (iTBS 1200) over the posterior superior temporal sulcus 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 posterior superior temporal sulcus for 4 weeks (2 days/week) and then received the real intervention of TBS (iTBS 1200) over the posterior superior temporal sulcus for 4 weeks (2 days/week). *iTBS = intermittent theta burst stimulation

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
RBS-R is a questionnaire that focuses on repetitive behavior. The score range from 0-129. The lower scores stand for lower repetitive behavior.

Secondary Outcome Measures

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 (The score ranges from 0-48).
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 (The score ranges from 0-43).
Functional MRI (Biological Motion Task)
The MRI data have to be pre-processed before analysis. It may take few years.
Resting State fMRI
The MRI data have to be pre-processed before analysis. It may take few years.
Diffusion Tensor Imaging
The MRI data have to be pre-processed before analysis. It may take few years.

Full Information

First Posted
July 7, 2018
Last Updated
August 4, 2021
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03621189
Brief Title
The Impacts of Theta-burst Stimulation on Children and Adolescents With Autism Spectrum Disorder
Official Title
The Impacts of Theta-burst Stimulation Over Posterior Superior Temporal Sulcus on Children and Adolescents With Autism Spectrum Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
November 2, 2016 (Actual)
Primary Completion Date
April 17, 2019 (Actual)
Study Completion Date
April 17, 2019 (Actual)

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 posterior superior temporal sulcus in children and adolescents with 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
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active-Active
Arm Type
Active Comparator
Arm Description
Participants received the real intervention of TBS (iTBS 1200) over the posterior superior temporal sulcus for 8 weeks (2 days/week). *iTBS = intermittent theta burst stimulation
Arm Title
Sham-Active
Arm Type
Sham Comparator
Arm Description
Participants received the sham intervention of TBS (coil tilted one-wing 90° off the head) over the posterior superior temporal sulcus for 4 weeks (2 days/week) and then received the real intervention of TBS (iTBS 1200) over the posterior superior temporal sulcus for 4 weeks (2 days/week). *iTBS = intermittent theta burst stimulation
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; during TBS (4 weeks after 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
RBS-R is a questionnaire that focuses on repetitive behavior. The score range from 0-129. The lower scores stand for lower repetitive behavior.
Time Frame
baseline; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)
Secondary Outcome Measure Information:
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 (The score ranges from 0-48).
Time Frame
baseline; during TBS (4 weeks after 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 (The score ranges from 0-43).
Time Frame
baseline; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)
Title
Functional MRI (Biological Motion Task)
Description
The MRI data have to be pre-processed before analysis. It may take few years.
Time Frame
baseline; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline)
Title
Resting State fMRI
Description
The MRI data have to be pre-processed before analysis. It may take few years.
Time Frame
baseline; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline)
Title
Diffusion Tensor Imaging
Description
The MRI data have to be pre-processed before analysis. It may take few years.
Time Frame
baseline; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Taoyuan
ZIP/Postal Code
33305
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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The Impacts of Theta-burst Stimulation on Children and Adolescents With Autism Spectrum Disorder

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