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

July 7, 2022 updated by: Chang Gung Memorial Hospital

To Explore the Therapeutic Effects of Continuous Theta-burst Stimulation Over Left Dorsolateral Prefrontal Cortex in Autism Spectrum Disorder

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taoyuan, Taiwan, 33305
        • Recruiting
        • Chang Gung Memorial Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 30 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active

Participants received the real intervention of TBS (cTBS 600) over the left dorsolateral prefrontal cortex for 8 weeks (2 days/week).

*cTBS = continuous theta burst stimulation
Device: continuous theta burst stimulation
stimulatory protocol
Sham Comparator: Sham
Participants received the sham intervention of TBS (coil tilted one-wing 90° off the head) over the left dorsolateral prefrontal cortex for 8 weeks (2 days/week).
Device: continuous theta burst stimulation
stimulatory protocol
No Intervention: Normal control
No intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of total scores of Social Responsiveness Scale
Time Frame: baseline; post TBS (8 weeks after baseline); One month follow up (4 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.
baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)
Changes of total scores of Repetitive Behavior Scale-Revised
Time Frame: baseline; post TBS (8 weeks after baseline); One month follow up (4 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.
baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of total scores of Emotional Dysregulation Inventory
Time Frame: baseline; post TBS (8 weeks after baseline); One month follow up (4 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.
baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)
Changes in accuracy of Frith-Happe animation
Time Frame: baseline; post TBS (8 weeks after baseline); One month follow up (4 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.
baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)
Changes in accuracy of Eyes task
Time Frame: baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)
An advanced test for Theory of Mind. 43 questions in total, the more correct questions stand for better social skills.
baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)
Changes in accuracy of Wisconsin Card Sorting Test
Time Frame: baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)
An advanced test for cognitive flexibility. 128 questions in total, the more correct questions stand for better cognitive flexibility.
baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)
Raven's Progressive Matrices
Time Frame: baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)
An advanced test for for executive function. 60 questions in total, the more correct questions stand for better executive function.
baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)
Changes of total scores of Adaptive Behavior Assessment System
Time Frame: baseline; post TBS (8 weeks after baseline); One month follow up (4 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.
baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)
Changes of total scores of Vineland Adaptive Behavior Scales
Time Frame: baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)
Vineland Adaptive Behavior Scales is a parents' report questionnaire for adaptive behavior. The score ranges from 0-484. The higher scores stand for better adaptive behavior.
baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)
Changes of total scores of Behavior Rating Inventory of Executive Function
Time Frame: baseline; post TBS (8 weeks after baseline); One month follow up (4 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.
baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)
Autism Diagnostic Observation Schedule - Generic
Time Frame: baseline; post TBS (8 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.
baseline; post TBS (8 weeks after baseline)
MRI T1
Time Frame: baseline; post TBS (8 weeks after baseline)
Brain structural volumes (cm²)
baseline; post TBS (8 weeks after baseline)
functional MRI (resting-state/biological motion task) - BOLD signal
Time Frame: baseline; post TBS (8 weeks after baseline)
Blood-oxygen-level-dependent (BOLD) signal is a measurement used in fMRI, which reflects the neural activity.
baseline; post TBS (8 weeks after baseline)
Diffusion Tensor Imaging (DTI) - FA
Time Frame: baseline; post TBS (8 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.
baseline; post TBS (8 weeks after baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2019

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

September 1, 2022

Study Registration Dates

First Submitted

July 12, 2021

First Submitted That Met QC Criteria

July 28, 2021

First Posted (Actual)

August 6, 2021

Study Record Updates

Last Update Posted (Actual)

July 8, 2022

Last Update Submitted That Met QC Criteria

July 7, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201802246A0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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