Autism Spectrum DisorderNCT04993144
The Therapeutic Effects of Continuous Theta Burst Stimulation in Autism Spectrum Disorder
A study testing continuous theta burst stimulation in people with Autism Spectrum Disorder, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The investigator would like to investigate the impact of theta burst stimulation over left dorsolateral prefrontal cortex in autism spectrum disorder Read more about this study
- Who is it for?
- Ages 8 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- continuous theta burst stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Dec 2019to Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 8 to 30 years
- All sexes
- Healthy volunteers accepted
- 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, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Taoyuan, 33305
Hsing-Chang Ni, Dr, 88633281200 ext. 3815, alanni0918@yahoo.com.tw
About this study
Official title: To Explore the Therapeutic Effects of Continuous Theta-burst Stimulation Over Left Dorsolateral Prefrontal Cortex in Autism Spectrum Disorder
The investigator would like to investigate the impact of theta burst stimulation over left dorsolateral prefrontal cortex in autism spectrum disorder
- Conditions
- Autism Spectrum Disorder
- Being tested
- continuous 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.
continuous theta burst stimulationDevice
stimulatory protocol
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | Participants received the real intervention of TBS (cTBS 600) over the left dorsolateral prefrontal cortex for 8 weeks (2 days/week).
*cTBS = continuous theta burst stimulation Receives: Device: continuous theta burst stimulation |
| Sham | Sham comparator | Participants received the sham intervention of TBS (coil tilted one-wing 90° off the head) over the left dorsolateral prefrontal cortex for 8 weeks (2 days/week). Receives: Device: continuous theta burst stimulation |
| Normal control | No intervention | No intervention. |
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; 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.
Measured: 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
Emotional Dysregulation Inventory is a parents' report questionnaire for emotional dysregulation. The score ranges from 0-120. The lower scores stand for better emotional regulation.
Measured: 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
Adaptive Behavior Assessment System is a parents' report questionnaire for adaptive behavior. The score ranges from 9-171. The higher scores stand for better adaptive behavior.
Measured: baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)
Changes of total scores of Vineland Adaptive Behavior Scales
Vineland Adaptive Behavior Scales is a parents' report questionnaire for adaptive behavior. The score ranges from 0-484. The higher scores stand for better adaptive behavior.
Measured: baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)
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.
Measured: 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.
Measured: baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)
Changes in accuracy of Wisconsin Card Sorting Test
An advanced test for cognitive flexibility. 128 questions in total, the more correct questions stand for better cognitive flexibility.
Measured: baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)
Changes of total scores of Behavior Rating Inventory of Executive Function
Behavior Rating Inventory of Executive Function is a parents' report questionnaire for executive function. The score ranges from 86-258. The lower scores stand for better executive function.
Measured: baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)
Raven's Progressive Matrices
An advanced test for for executive function. 60 questions in total, the more correct questions stand for better executive function.
Measured: baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)
Autism Diagnostic Observation Schedule - Generic
The Autism Diagnostic Observation Schedule is a semi-structured assessment of communication, social interaction, and play (or imaginative use of materials) for individuals suspected of having autism spectrum disorders. The social affect domain includes the social and communication items ranging from 0 to 20. The higher scores stand for more clinical severity of autism spectrum disorder.
Measured: baseline; post TBS (8 weeks after baseline)
MRI T1
Brain structural volumes (cm²)
Measured: baseline; post TBS (8 weeks after baseline)
functional MRI (resting-state/biological motion task) - BOLD signal
Blood-oxygen-level-dependent (BOLD) signal is a measurement used in fMRI, which reflects the neural activity.
Measured: baseline; post TBS (8 weeks after baseline)
Diffusion Tensor Imaging (DTI) - FA
Fractional anisotropy (FA) is a measurement used in DTI, which reflects the movement of water molecules. FA ranges from 0 to 1, the higher FA value may represent more intact axons.
Measured: 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.
- First posted6 Aug 2021
- Study start10 Dec 2019
- Primary completionSep 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04993144
- Sponsor's protocol ID
- 201802246A0
- Status last verified
- Jul 2022
- First submitted
- 12 Jul 2021
- Last updated
- 8 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Explore the Therapeutic Effects of Continuous Theta-burst Stimulation Over Left Dorsolateral Prefrontal Cortex in Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT04993144
- Acronym / sponsor ID
- 201802246A0
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 6 Aug 2021 (actual)
- Results
- Not posted in the source record
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 left dorsolateral prefrontal cortex in autism spectrum disorder
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Device: continuous theta burst stimulationParticipants received the real intervention of TBS (cTBS 600) over the left dorsolateral prefrontal cortex for 8 weeks (2 days/week). *cTBS = continuous theta burst stimulation |
| Sham | Sham comparator | Device: continuous theta burst stimulationParticipants received the sham intervention of TBS (coil tilted one-wing 90° off the head) over the left dorsolateral prefrontal cortex for 8 weeks (2 days/week). |
| Normal control | No intervention | –No intervention. |
Who may qualify
- Ages
- 8 to 30 years
- Sex
- All
- Healthy volunteers
- 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 |
|---|---|---|
| continuous theta burst stimulationstimulatory protocol | Device | Active, Sham |
Primary outcome
Changes of total scores of Social Responsiveness Scale
Time frame: 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; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)
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.
12 secondary outcomes
Changes of total scores of Emotional Dysregulation Inventory
Time frame: 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
Time frame: baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)
Changes of total scores of Vineland Adaptive Behavior Scales
Time frame: baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)
Changes in accuracy of Frith-Happe animation
Time frame: 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; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)
Changes in accuracy of Wisconsin Card Sorting Test
Time frame: baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)
Changes of total scores of Behavior Rating Inventory of Executive Function
Time frame: baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)
Raven's Progressive Matrices
Time frame: baseline; post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)
Autism Diagnostic Observation Schedule - Generic
Time frame: baseline; post TBS (8 weeks after baseline)
MRI T1
Time frame: baseline; post TBS (8 weeks after baseline)
functional MRI (resting-state/biological motion task) - BOLD signal
Time frame: baseline; post TBS (8 weeks after baseline)
Diffusion Tensor Imaging (DTI) - FA
Time frame: baseline; post TBS (8 weeks after baseline)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2022.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing continuous 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: status not confirmed, as of the sponsor's last update on 8 Jul 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hsing-Chang Ni, Dr. (88633281200 ext. 3815, alanni0918@yahoo.com.tw), or a site near the patient. 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; 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?
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 8 Jul 2022.