Autism Spectrum DisorderNCT03621189

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

A study testing intermittent theta burst stimulation in people with Autism Spectrum Disorder, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 7 to 18 years
Conditions the study is for: Autism Spectrum Disorder
What is being tested?: intermittent theta burst stimulation
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 80 participants
Where: 1 siteTaiwan
Study dates: 2 Nov 2016to 17 Apr 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 7 to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

autism spectrum disorder, confirmed by ADOS

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

Chang Gung Memorial Hospital
Taoyuan, 33305

Other trials in Taiwan

About this study

Official title: The Impacts of Theta-burst Stimulation Over Posterior Superior Temporal Sulcus 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

Conditions: Autism Spectrum Disorder
Being tested: intermittent theta burst stimulation
Medical subject headings: Autism Spectrum Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

intermittent theta burst stimulationDevice
stimulatory protocol

Study groups in NCT03621189
Study group	Role	What they receive
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 Receives: 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 Receives: Device: intermittent theta burst stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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
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).
Measured: 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
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).
Measured: 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)
The MRI data have to be pre-processed before analysis. It may take few years.
Measured: baseline; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline)
Resting State fMRI
The MRI data have to be pre-processed before analysis. It may take few years.
Measured: baseline; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline)
Diffusion Tensor Imaging
The MRI data have to be pre-processed before analysis. It may take few years.
Measured: baseline; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Nov 201617 Apr 2019

First posted8 Aug 2018
Study start2 Nov 2016
Primary completion17 Apr 2019
Study completion17 Apr 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03621189
Sponsor's protocol ID: 201509413A0
Status last verified: Aug 2018
First submitted: 7 Jul 2018
Last updated: 23 Jan 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

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.
PubMed 36638598

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Impacts of Theta-burst Stimulation Over Posterior Superior Temporal Sulcus on Children and Adolescents With Autism Spectrum Disorder
ClinicalTrials.gov ID: NCT03621189
Acronym / sponsor ID: 201509413A0
Conditions: Autism Spectrum Disorder
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Chang Gung Memorial HospitalUniversity, hospital or other
Study start: 2 Nov 2016 (actual)
Primary completion: 17 Apr 2019 (actual)
Study completion: 17 Apr 2019 (actual)
First posted: 8 Aug 2018 (actual)
Results: Posted 27 Aug 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 2

Arm	Type	Receives
Active-Active	Active comparator	Device: intermittent theta burst stimulationParticipants 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
Sham-Active	Sham comparator	Device: intermittent theta burst stimulationParticipants 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

Who may qualify

Ages: 7 to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (1 listed)

autism spectrum disorder, confirmed by ADOS

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
intermittent theta burst stimulationstimulatory protocol	Device	Active-Active, Sham-Active

Primary outcome

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.
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.

5 secondary outcomes

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)
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)
Functional MRI (Biological Motion Task)
Time frame: baseline; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline)
Resting State fMRI
Time frame: baseline; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline)
Diffusion Tensor Imaging
Time frame: baseline; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline)

Results and safety

Results posted to the registry on 27 Aug 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active-Active	40	40
Sham-Active	40	35

Primary outcome: 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). Mean (Standard Deviation). Unit: score on a scale

Measure	Active-Active n = 40	Sham-Active n = 35
Baseline	107.3 (24)	102.1 (23.2)
During TBS	103.4 (25.5)	100.1 (27.1)
Post TBS	98.5 (28.7)	95.1 (25.7)
One month follow up	97.2 (25.6)	94.7 (27.9)

Primary outcome: 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). Mean (Standard Deviation). Unit: score on a scale

Measure	Active-Active n = 40	Sham-Active n = 35
Baseline	32.2 (18.9)	33.5 (20.6)
During TBS	28.9 (20.1)	28.1 (21.5)
Post TBS	25.9 (20.5)	31.5 (23.9)
One month follow up	24.3 (17.6)	29 (23.9)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: The adverse event would be assessed before and after intervention every session, up to 4 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active-Active	0 of 40 (0%)	4 of 40 (10%)	0 of 40
Sham-Active	0 of 35 (0%)	10 of 35 (28.6%)	0 of 35

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36638598Ni 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.
Individual participant dataSharing planned: Undecided

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Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing intermittent theta burst stimulation in people with Autism Spectrum Disorder, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03621189, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2024.