Autism Spectrum DisorderNCT05735262
pBFS Guided Precision Neuromodulation Treatment for ASD
A study testing active iTBS in people with Autism Spectrum Disorder, run by Changping Laboratory at 1 site in China.
Trial summary
This study aims to evaluate the neuromodulation (i.e., iTBS) effectiveness for treating autism spectrum disorder (ASD) by targeting at the pBFS-guided executive function brain network or social brain network. Read more about this study
- Who is it for?
- Ages 6 to 30 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- active iTBS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 7 Mar 2023to 1 Jan 2025
- 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 6 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 6-30 years old
- Have the diagnosis of autism spectrum disorder
- ADOS-2 score is higher than the ASD cut-offs
- Capacity to follow the study procedures, including fMRI scan under sedation, assessment, and rehabilitation training
- Participant's parents or other legal guardians give informed consent
Who cannot join
- Current or history of psychotic disorders, such as schizophrenia, bipolar disorder
- Severe self-injury or suicidal behavior presented in the last 1 year
- Severe visual, auditory, or motor disability that interferes with any study procedure
- Current, history or family history of epilepsy
- Known severe physical diseases, such as congenital heart defects, traumatic brain injury
- Metal implantations, which are contradicted by MRI or TMS, such as artificial cardiac pacemakers, stents, cochlear implants
- Received TMS, tCS, FUS, or other neuromodulation treatment in the last 3 months
- Currently participating in other clinical trials
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
China Rehabilitation Research Center
Beijing
Hao Zhang
About this study
Official title: Personalized Brain Functional Sectors (pBFS) Guided Precision Neuromodulation Treatment for Autism Spectrum Disorder (ASD): a Single-center, Sham-controlled, Double-blinded, Randomized Clinical Trial Study
This study aims to evaluate the neuromodulation (i.e., iTBS) effectiveness for treating autism spectrum disorder (ASD) by targeting at the pBFS-guided executive function brain network or social brain network.
Read the detailed description
Autism spectrum disorder is characterized by executive function deficiency and social interaction difficulty. Using the developed technique, personalized brain functional sectors (pBFS), we could precisely identify individualized brain function networks based on the resting-state functional MRI scan. A tailored dorsal lateral prefrontal cortex (DLPFC) region situated within the executive function network and a tailored dorsal medial prefrontal cortex (DMPFC) region situated within the social network will be selected as intervention targets.
The participants will be equally randomized to the following three groups, active iTBS to the left DLPFC, active iTBS to the left DMPFC, and sham iTBS to either the left DLPFC or left DMPFC at a ratio of 2:2:1:1. Each participant will receive 1800 pulse active or sham iTBS (100% RMT) in each session, 3 sessions daily, 5 days per week for 8 weeks, as well as background behavioral training between iTBS sessions.
- Conditions
- Autism Spectrum Disorder
- Being tested
- active iTBS, sham iTBS
- Keywords
- TMS, fMRI, ASD, personalized
- 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.
active iTBSDevice
Each participant will receive 1800 pulse active iTBS (100% RMT) in each session, 3 sessions per day, 5 days per week for 8 weeks.
sham iTBSDevice
Each participant will receive 1800 pulse sham iTBS (100% RMT) in each session, 3 sessions per day, 5 days per week for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| DLPFC group | Experimental | Active iTBS will be delivered to the left DLPFC. Receives: Device: active iTBS |
| DMPFC group | Experimental | Active iTBS will be delivered to the left DMPFC. Receives: Device: active iTBS |
| Sham to DLPFC group | Sham comparator | Sham iTBS will be delivered to left DLPFC. Receives: Device: sham iTBS |
| Sham to DMPFC group | Sham comparator | Sham iTBS will be delivered to left DMPFC. Receives: Device: sham iTBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADOS-2 SA change
The social affect (SA) dimension score change of autism diagnostic observation scale, 2nd edition (ADOS-2) from baseline
Measured: Pre-treatment (baseline), immediately post-treatment
Secondary outcomes (2)
ADOS-2 total score change
The total score change of autism diagnostic observation scale, 2nd edition (ADOS-2) from baseline
Measured: Pre-treatment (baseline), immediately post-treatment
CBCL score change
Score change of the child behavior checklist (CBCL) from baseline
Measured: Pre-treatment (baseline), immediately post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start7 Mar 2023
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Jan 2025 (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.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changping Laboratory
- Sponsor type
- University, hospital or other
- Collaborators
- China Rehabilitation Research Center
- Responsible party
- Sponsor
- Investigators
- Hesheng Liu, Ph.D., Study chair, Changping Laboratory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05735262
- Sponsor's protocol ID
- CPASD2023BA100
- Status last verified
- Feb 2023
- First submitted
- 8 Feb 2023
- Last updated
- 30 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Brain Functional Sectors (pBFS) Guided Precision Neuromodulation Treatment for Autism Spectrum Disorder (ASD): a Single-center, Sham-controlled, Double-blinded, Randomized Clinical Trial Study
- ClinicalTrials.gov ID
- NCT05735262
- Acronym / sponsor ID
- CPASD2023BA100
- Conditions
- Autism Spectrum Disorder
- Keywords
- TMS, fMRI, ASD, personalized
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Changping LaboratoryUniversity, hospital or other
- Collaborators
- China Rehabilitation Research Center
- Study start
- 7 Mar 2023 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 21 Feb 2023 (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.
This study aims to evaluate the neuromodulation (i.e., iTBS) effectiveness for treating autism spectrum disorder (ASD) by targeting at the pBFS-guided executive function brain network or social brain network.
Detailed description
Autism spectrum disorder is characterized by executive function deficiency and social interaction difficulty. Using the developed technique, personalized brain functional sectors (pBFS), we could precisely identify individualized brain function networks based on the resting-state functional MRI scan. A tailored dorsal lateral prefrontal cortex (DLPFC) region situated within the executive function network and a tailored dorsal medial prefrontal cortex (DMPFC) region situated within the social network will be selected as intervention targets.
The participants will be equally randomized to the following three groups, active iTBS to the left DLPFC, active iTBS to the left DMPFC, and sham iTBS to either the left DLPFC or left DMPFC at a ratio of 2:2:1:1. Each participant will receive 1800 pulse active or sham iTBS (100% RMT) in each session, 3 sessions daily, 5 days per week for 8 weeks, as well as background behavioral training between iTBS sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| DLPFC group | Experimental | Device: active iTBSActive iTBS will be delivered to the left DLPFC. |
| DMPFC group | Experimental | Device: active iTBSActive iTBS will be delivered to the left DMPFC. |
| Sham to DLPFC group | Sham comparator | Device: sham iTBSSham iTBS will be delivered to left DLPFC. |
| Sham to DMPFC group | Sham comparator | Device: sham iTBSSham iTBS will be delivered to left DMPFC. |
Who may qualify
- Ages
- 6 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 6-30 years old
- Have the diagnosis of autism spectrum disorder
- ADOS-2 score is higher than the ASD cut-offs
- Capacity to follow the study procedures, including fMRI scan under sedation, assessment, and rehabilitation training
- Participant's parents or other legal guardians give informed consent
Key exclusion criteria (8 listed)
- Current or history of psychotic disorders, such as schizophrenia, bipolar disorder
- Severe self-injury or suicidal behavior presented in the last 1 year
- Severe visual, auditory, or motor disability that interferes with any study procedure
- Current, history or family history of epilepsy
- Known severe physical diseases, such as congenital heart defects, traumatic brain injury
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 |
|---|---|---|
| active iTBSEach participant will receive 1800 pulse active iTBS (100% RMT) in each session, 3 sessions per day, 5 days per week for 8 weeks. | Device | DLPFC group, DMPFC group |
| sham iTBSEach participant will receive 1800 pulse sham iTBS (100% RMT) in each session, 3 sessions per day, 5 days per week for 8 weeks. | Device | Sham to DLPFC group, Sham to DMPFC group |
Primary outcome
ADOS-2 SA change
Time frame: Pre-treatment (baseline), immediately post-treatment
The social affect (SA) dimension score change of autism diagnostic observation scale, 2nd edition (ADOS-2) from baseline
2 secondary outcomes
ADOS-2 total score change
Time frame: Pre-treatment (baseline), immediately post-treatment
CBCL score change
Time frame: Pre-treatment (baseline), immediately post-treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2023.
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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.
Hesheng Liu, Ph.D. study chair
Changping Laboratory
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active iTBS in people with Autism Spectrum Disorder, run by Changping Laboratory at 1 site in China.
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 5 inclusion and 8 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 30 May 2023. 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 China. 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 Qi Liu (010-80726688, a0000153@cpl.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ADOS-2 SA change (time frame: Pre-treatment (baseline), immediately post-treatment). 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 30 May 2023.