NCT03621189

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 2, 2016

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

July 7, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 8, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 17, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 17, 2019

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

August 27, 2021

Completed
Last Updated

January 23, 2024

Status Verified

August 1, 2018

Enrollment Period

2.5 years

First QC Date

July 7, 2018

Results QC Date

July 12, 2021

Last Update Submit

January 3, 2024

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (2)

  • 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.

    baseline; during TBS (4 weeks after 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

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

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

Secondary Outcomes (5)

  • Changes in Accuracy of Frith-Happe Animation

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

  • Changes in Accuracy of Eyes Task

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

  • Functional MRI (Biological Motion Task)

    baseline; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline)

  • Resting State fMRI

    baseline; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline)

  • Diffusion Tensor Imaging

    baseline; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline)

Study Arms (2)

Active-Active

ACTIVE COMPARATOR

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

Device: intermittent theta burst stimulation

Sham-Active

SHAM COMPARATOR

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

Device: intermittent theta burst stimulation

Interventions

intermittent theta burst stimulationDEVICE

stimulatory protocol

Active-ActiveSham-Active

Eligibility Criteria

Age7 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • autism spectrum disorder, confirmed by ADOS

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, 33305, Taiwan

Location

Related Publications (1)

  • Ni HC, Chao YP, Tseng RY, Wu CT, Cocchi L, Chou TL, Chen RS, Gau SS, Yeh CH, Lin HY. Lack of effects of four-week theta burst stimulation on white matter macro/microstructure in children and adolescents with autism. Neuroimage Clin. 2023;37:103324. doi: 10.1016/j.nicl.2023.103324. Epub 2023 Jan 7.

    PMID: 36638598DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Results Point of Contact

Title
Dr. Hsing Chang Ni
Organization
Chang Gung Memorial Hospital
alanni0918@yahoo.com.tw
886975365663

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2018

First Posted

August 8, 2018

Study Start

November 2, 2016

Primary Completion

April 17, 2019

Study Completion

April 17, 2019

Last Updated

January 23, 2024

Results First Posted

August 27, 2021

Record last verified: 2018-08

Locations

TW(1)