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

NCT ID: NCT03621189

Last Updated: 2024-01-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-02

Study Completion Date

2019-04-17

Brief Summary

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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

Detailed Description

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Conditions

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Autism Spectrum Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Active-Active

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

Group Type ACTIVE_COMPARATOR

intermittent theta burst stimulation

Intervention Type DEVICE

stimulatory protocol

Sham-Active

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

Group Type SHAM_COMPARATOR

intermittent theta burst stimulation

Intervention Type DEVICE

stimulatory protocol

Interventions

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intermittent theta burst stimulation

stimulatory protocol

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type DERIVED
PMID: 36638598 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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201509413A0

Identifier Type: -

Identifier Source: org_study_id

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