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Completed

NCT Number: NCT03621189

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

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

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Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

7 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung Memorial Hospital

Taoyuan, 33305, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intermittent Theta Burst Stimulation

Device

stimulatory protocol

Primary outcomes

  1. Changes of Total Scores of Social Responsiveness Scale

    Time frame: baseline; during TBS (4 weeks after 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.

  2. Changes of Total Scores of Repetitive Behavior Scale-Revised

    Time frame: baseline; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)

    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 outcomes

  1. Changes in Accuracy of Frith-Happe Animation

    Time frame: baseline; during TBS (4 weeks after 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 (The score ranges from 0-48).

  2. Changes in Accuracy of Eyes Task

    Time frame: baseline; during TBS (4 weeks after 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 (The score ranges from 0-43).

  3. Functional MRI (Biological Motion Task)

    Time frame: baseline; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline)

    The MRI data have to be pre-processed before analysis. It may take few years.

  4. Resting State fMRI

    Time frame: baseline; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline)

    The MRI data have to be pre-processed before analysis. It may take few years.

  5. Diffusion Tensor Imaging

    Time frame: baseline; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline)

    The MRI data have to be pre-processed before analysis. It may take few years.

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

The Impacts of Theta-burst Stimulation Over Posterior Superior Temporal Sulcus on Children and Adolescents With Autism Spectrum Disorder

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Aug 8, 2018
Registry last updated
Jan 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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