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

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ClinicalTrials.gov Identifier: NCT03621189
Recruitment Status : Recruiting
First Posted : August 8, 2018
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
Hsing Chang Ni, Chang Gung Memorial Hospital

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

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Device: intermittent theta burst stimulation Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: the Impacts of Theta-burst Stimulation Over Posterior Superior Temporal Sulcus on Children and Adolescents With Autism Spectrum Disorder
Actual Study Start Date : November 2016
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: posterior superior temporal sulcus
iTBS 1200
Device: intermittent theta burst stimulation
stimulatory protocol

Sham Comparator: Sham control
iTBS 1200
Device: intermittent theta burst stimulation
stimulatory protocol




Primary Outcome Measures :
  1. Changes of total scores of Autism spectrum quotient [ Time Frame: baseline; during TBS (4 weeks after baseline); post TBS (8weeks after baseline); One month follow up (4 weeks after post TBS) ]
    parents' report questionnaire for autism clinical severity

  2. Changes of total scores of Social communication questionnaire [ Time Frame: baseline; during TBS (4 weeks after baseline); post TBS (8weeks after baseline); One month follow up (4 weeks after post TBS) ]
    parents' report questionnaire for autism clinical severity

  3. Changes of total scores of Social responsiveness scale [ Time Frame: baseline; during TBS (4 weeks after baseline); post TBS (8weeks after baseline); One month follow up (4 weeks after post TBS) ]
    parents' report questionnaire for autism clinical severity (score range:65-260)(Higher scores represent a worse outcome)

  4. Changes of total scores of Repetitive Behavior Scale-Revised [ Time Frame: baseline; during TBS (4 weeks after baseline); post TBS (8weeks after baseline); One month follow up (4 weeks after post TBS) ]
    parents' report questionnaire for repetitive behaviors


Secondary Outcome Measures :
  1. Changes in accuracy of Frith-Happe animation [ Time Frame: baseline; during TBS (4 weeks after baseline); post TBS (8weeks after baseline); One month follow up (4 weeks after post TBS) ]
    a quick and objective test of Theory of Mind

  2. Changes in accuracy of Eyes task [ Time Frame: baseline; during TBS (4 weeks after baseline); post TBS (8weeks after baseline); One month follow up (4 weeks after post TBS) ]
    An advanced test for Theory of mind

  3. functional MRI (biological motion task) [ Time Frame: baseline; during TBS (4 weeks after baseline); post TBS (8weeks after baseline) ]
  4. resting state fMRI [ Time Frame: baseline; during TBS (4 weeks after baseline); post TBS (8weeks after baseline) ]
  5. Diffusion Tensor Imaging [ Time Frame: baseline; during TBS (4 weeks after baseline); post TBS (8weeks after baseline) ]


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Ages Eligible for Study:   7 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03621189


Contacts
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Contact: Hsing-Chang Ni, Dr. 88633281200 ext 2479 alanni0918@yahoo.com.tw

Locations
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Taiwan
Chang Gung Memorial Hospital Recruiting
Taoyuan, Taiwan, 33305
Contact: Hsing-Chang Ni, Dr    88633281200 ext 2479    alanni0918@yahoo.com.tw   
Sponsors and Collaborators
Chang Gung Memorial Hospital

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Responsible Party: Hsing Chang Ni, Assistant professor, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT03621189     History of Changes
Other Study ID Numbers: 104-9413A
First Posted: August 8, 2018    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Additional relevant MeSH terms:
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Disease
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders