NCT04987749

Brief Summary

The investigator would like to investigate the impact of theta burst stimulation over right inferior frontal gyrus in autism spectrum disorder

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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 5, 2019

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

July 12, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

August 3, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

July 8, 2022

Status Verified

July 1, 2022

Enrollment Period

3.7 years

First QC Date

July 12, 2021

Last Update Submit

July 7, 2022

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

  • Changes of total scores of Repetitive Behavior Scale-Revised

    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 Outcomes (12)

  • Changes of total scores of Emotional Dysregulation Inventory

    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

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

  • Changes in accuracy of Frith-Happe animation

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

  • Changes in accuracy of Eyes task

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

  • Changes in accuracy of Wisconsin Card Sorting Test

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

  • +7 more secondary outcomes

Study Arms (2)

Active

ACTIVE COMPARATOR

Participants received the real intervention of TBS (iTBS 600) over the right inferior frontal gyrus for 8 weeks (2 days/week). \*iTBS = intermittent theta burst stimulation

Device: intermittent theta burst stimulation

Sham

SHAM COMPARATOR

Participants received the sham intervention of TBS (coil tilted one-wing 90° off the head) over the right inferior frontal gyrus for 8 weeks (2 days/week).

Device: intermittent theta burst stimulation

Interventions

intermittent theta burst stimulationDEVICE

stimulatory protocol

ActiveSham

Eligibility Criteria

Age8 Years - 30 Years
Sexall
Healthy VolunteersYes
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

RECRUITING

Related Publications (1)

  • Ni HC, Chen YL, Hsieh MY, Wu CT, Chen RS, Juan CH, Li CT, Gau SS, Lin HY. Improving social cognition following theta burst stimulation over the right inferior frontal gyrus in autism spectrum: an 8-week double-blind sham-controlled trial. Psychol Med. 2024 Sep 6:1-12. doi: 10.1017/S0033291724001387. Online ahead of print.

    PMID: 39238103DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Central Study Contacts

Hsing-Chang Ni

CONTACT

88633281200alanni0918@yahoo.com.tw

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 12, 2021

First Posted

August 3, 2021

Study Start

November 5, 2019

Primary Completion

August 1, 2023

Study Completion

November 1, 2023

Last Updated

July 8, 2022

Record last verified: 2022-07

Locations

TW(1)