Autism Spectrum DisorderNCT05890846
Precision TMS Treatment Guided by Personalized Brain Functional Sectors (pBFS) for ASD
A study testing active iTBS and traditional 1on1 course in people with Autism Spectrum Disorder, run by Changping Laboratory at 2 sites in China.
Trial summary
This study will evaluate the efficacy and safety of pBFS-guided TMS treatment for the core symptom in autism spectrum disorder children, adolescents and young adults. 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 and traditional 1on1 course
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 2 sitesChina
- Study dates
- 25 Jun 2022to 20 Sep 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
- Nearest age 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 parent or other legal guardian give informed consent
Who cannot join
- Current or history of psychotic disorders, such as schizophrenia, schizoaffective disorder, bipolar disorder
- Severe self-injury or suicidal behavior presented in the last one year
- Severe visual, auditory, or motor disability that interferes with any study procedure
- Current or history of seizure
- Known severe physical diseases, such as congenital heart defect, 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
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
China Rehabilitation Research Center
Beijing
Hao Zhang, M.D.,Ph.D.
- Recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan
Meiyun Wang, M.D.,Ph.D.
About this study
Official title: Personalized Brain Functional Sectors (pBFS) Guided Transcranial Magnetic Stimulation (TMS) Treatment for Autism Spectrum Disorder (ASD): a Sham-controlled, Double-blinded, Randomized Clinical Trial Study
This study will evaluate the efficacy and safety of pBFS-guided TMS treatment for the core symptom in autism spectrum disorder children, adolescents and young adults.
Read the detailed description
Autism spectrum disorder is a neurodevelopmental disorder characterized by impaired social communication and repetitive behaviors. Broad cognitive control function deficit in ASD suggested cognitive control function as a potential phenotype and treatment target. Using the personalized Brain Functional Sectors (pBFS) technique, investigators could precisely identify individualized brain areas underlying cognitive control function based on the task free functional MRI data. The tailored TMS intervention target to cognitive control function network which located in the left dorsal lateral prefrontal cortex (DLPFC) will be selected for each participant by a blinded researcher.
The participants will be equally randomized to the active iTBS to the cognitive control function network, and sham iTBS at a ratio of 2:1. Each participant will receive 5 days of treatment per week for 12 weeks. Functional MRI data under sedation will be collected pre-and post-treatment. Three behavioral evaluations will be taken pre-treatment, after 8-weeks treatment and after 12-weeks treatment.
- Conditions
- Autism Spectrum Disorder
- Being tested
- active iTBS, sham iTBS, traditional 1on1 course
- Keywords
- TMS, personalized medicine, ASD, fMRI
- 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 12 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 12 weeks.
traditional 1on1 courseBehavioural
Between every two iTBS sessions, the participant will receive a personalized 30-minutes one-on-one behavioral course, 2 courses per day, 5 days per week for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| DLPFC group | Experimental | Active iTBS will be delivered to the cognitive control network at left DLPFC. Receives: Device: active iTBS; Behavioral: traditional 1on1 course |
| Sham group | Sham comparator | Sham iTBS will be delivered to the cognitive control network at left DLPFC. Receives: Device: sham iTBS; Behavioral: traditional 1on1 course |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate after 12 weeks treatment
Treatment response is defined as improvement, i.e., scores decreased, in both the social affect (SA) dimension score change of autism diagnostic observation scale, 2nd edition (ADOS-2) from baseline. For ADOS-2 SA, higher scores means more severe symptom.
Measured: Pre-treatment (baseline), after 12-weeks treatment
Secondary outcomes (6)
Response rate after 8 weeks treatment
Treatment response is defined as improvement, i.e., scores decreased, in the social affect (SA) dimension score change of autism diagnostic observation scale, 2nd edition (ADOS-2) from baseline. For ADOS-2 SA, higher scores means more severe symptom.
Measured: Pre-treatment (baseline), after 8-weeks treatment
ADOS-2 SA score change
The ADOS-2 SA score changes from baseline. Higher scores mean a worse outcome.
Measured: Pre-treatment (baseline), after 8-weeks treatment，after 12-weeks tretment
SCQ score change
SCQ score change from baseline. Higher scores mean a worse outcome.
Measured: Pre-treatment (baseline), after 8-weeks treatment，after 12-weeks tretment
ADOS-2 total score change
The ADOS-2 total score change from baseline. Higher scores mean a worse outcome.
Measured: Pre-treatment (baseline), after 8-weeks treatment，after 12-weeks tretment
CBCL score change
Score change of the child behavior checklist (CBCL) from baseline. Higher scores mean a worse outcome.
Measured: Pre-treatment (baseline), after 8-weeks treatment，after 12-weeks tretment
SRS-2 score change
Score change of the Social Responsiveness Scale, 2nd edition (SRS-2) from baseline. Higher scores mean a worse outcome.
Measured: Pre-treatment (baseline), after 8-weeks treatment，after 12-weeks tretment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2023
- Study start25 Jun 2022
- Primary completion20 Sep 2024 (estimated)
- Study completion20 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changping Laboratory
- Sponsor type
- University, hospital or other
- Collaborators
- Henan Provincial People's Hospital, China Rehabilitation Research Center
- Responsible party
- Sponsor
- Investigators
- Hesheng Liu, Ph.D., Study chair, Changping Laboratory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05890846
- Sponsor's protocol ID
- CPASD2023DL
- Status last verified
- Apr 2024
- First submitted
- 26 May 2023
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liu Q, Zhang J, Duan X, Zhang P, Yang Y, Yao G, Jiaerheng B, Shou XJ, He Y, Han K, Jia M, Wang L, Gong W, Xie W, Sun K, Wang D, Wu XD, Cao H, Zhang H, Liu H. Accelerated intermittent theta burst stimulation targeting personalized fronto-parietal control network improves core symptoms of autism spectrum disorder: a double-blind, randomized controlled trial. Mol Psychiatry. 2026 Sep;31(9):5070-5078. doi: 10.1038/s41380-026-03596-2. Epub 2026 Apr 15.
PubMed 41986743
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Brain Functional Sectors (pBFS) Guided Transcranial Magnetic Stimulation (TMS) Treatment for Autism Spectrum Disorder (ASD): a Sham-controlled, Double-blinded, Randomized Clinical Trial Study
- ClinicalTrials.gov ID
- NCT05890846
- Acronym / sponsor ID
- CPASD2023DL
- Conditions
- Autism Spectrum Disorder
- Keywords
- TMS, personalized medicine, ASD, fMRI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Changping LaboratoryUniversity, hospital or other
- Collaborators
- Henan Provincial People's Hospital, China Rehabilitation Research Center
- Study start
- 25 Jun 2022 (actual)
- Primary completion
- 20 Sep 2024 (estimated)
- Study completion
- 20 Sep 2025 (estimated)
- First posted
- 6 Jun 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 will evaluate the efficacy and safety of pBFS-guided TMS treatment for the core symptom in autism spectrum disorder children, adolescents and young adults.
Detailed description
Autism spectrum disorder is a neurodevelopmental disorder characterized by impaired social communication and repetitive behaviors. Broad cognitive control function deficit in ASD suggested cognitive control function as a potential phenotype and treatment target. Using the personalized Brain Functional Sectors (pBFS) technique, investigators could precisely identify individualized brain areas underlying cognitive control function based on the task free functional MRI data. The tailored TMS intervention target to cognitive control function network which located in the left dorsal lateral prefrontal cortex (DLPFC) will be selected for each participant by a blinded researcher.
The participants will be equally randomized to the active iTBS to the cognitive control function network, and sham iTBS at a ratio of 2:1. Each participant will receive 5 days of treatment per week for 12 weeks. Functional MRI data under sedation will be collected pre-and post-treatment. Three behavioral evaluations will be taken pre-treatment, after 8-weeks treatment and after 12-weeks treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DLPFC group | Experimental | Device: active iTBS, Behavioral: traditional 1on1 courseActive iTBS will be delivered to the cognitive control network at left DLPFC. |
| Sham group | Sham comparator | Device: sham iTBS, Behavioral: traditional 1on1 courseSham iTBS will be delivered to the cognitive control network at left DLPFC. |
Who may qualify
- Ages
- 6 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Nearest age 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 parent or other legal guardian give informed consent
Key exclusion criteria (8 listed)
- Current or history of psychotic disorders, such as schizophrenia, schizoaffective disorder, bipolar disorder
- Severe self-injury or suicidal behavior presented in the last one year
- Severe visual, auditory, or motor disability that interferes with any study procedure
- Current or history of seizure
- Known severe physical diseases, such as congenital heart defect, 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 12 weeks. | Device | DLPFC group |
| sham iTBSEach participant will receive 1800 pulse sham iTBS (100% RMT) in each session, 3 sessions per day, 5 days per week for 12 weeks. | Device | Sham group |
| traditional 1on1 courseBetween every two iTBS sessions, the participant will receive a personalized 30-minutes one-on-one behavioral course, 2 courses per day, 5 days per week for 12 weeks. | Behavioural | DLPFC group, Sham group |
Primary outcome
Response rate after 12 weeks treatment
Time frame: Pre-treatment (baseline), after 12-weeks treatment
Treatment response is defined as improvement, i.e., scores decreased, in both the social affect (SA) dimension score change of autism diagnostic observation scale, 2nd edition (ADOS-2) from baseline. For ADOS-2 SA, higher scores means more severe symptom.
6 secondary outcomes
Response rate after 8 weeks treatment
Time frame: Pre-treatment (baseline), after 8-weeks treatment
ADOS-2 SA score change
Time frame: Pre-treatment (baseline), after 8-weeks treatment，after 12-weeks tretment
SCQ score change
Time frame: Pre-treatment (baseline), after 8-weeks treatment，after 12-weeks tretment
ADOS-2 total score change
Time frame: Pre-treatment (baseline), after 8-weeks treatment，after 12-weeks tretment
CBCL score change
Time frame: Pre-treatment (baseline), after 8-weeks treatment，after 12-weeks tretment
SRS-2 score change
Time frame: Pre-treatment (baseline), after 8-weeks treatment，after 12-weeks tretment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Derived from this study: PubMed 41986743Liu Q, Zhang J, Duan X, Zhang P, Yang Y, Yao G, Jiaerheng B, Shou XJ, He Y, Han K, Jia M, Wang L, Gong W, Xie W, Sun K, Wang D, Wu XD, Cao H, Zhang H, Liu H. Accelerated intermittent theta burst stimulation targeting personalized fronto-parietal control network improves core symptoms of autism spectrum disorder: a double-blind, randomized controlled trial. Mol Psychiatry. 2026 Sep;31(9):5070-5078. doi: 10.1038/s41380-026-03596-2. Epub 2026 Apr 15.
Related trials for Autism Spectrum Disorder
Recruiting
Effectiveness of Clown Therapy in Facilitating Dental Visits for Children With Autism Spectrum Disorder
Autism Spectrum Disorder (ASD
Recruiting
Cerebellar Transcranial Direct Current Stimulation (tDCS) in Children With Autism Spectrum Disorder: Raynor Cerebellum Project
Autism Spectrum Disorder
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Not yet recruiting
Transdiagnostic Sleep and Circadian Treatment for Autistic Adolescents
Sleep, Autism Spectrum Disorder
RecruitingObservational study
Effectiveness of the Autism Pupil Screen (APS) Detect Pupillometer for Identifying Autism Spectrum Disorder (ASD) in Routine Healthcare
Autism Spectrum Disorder
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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active iTBS and traditional 1on1 course in people with Autism Spectrum Disorder, run by Changping Laboratory at 2 sites 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 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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, Ph.D. (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?
Response rate after 12 weeks treatment (time frame: Pre-treatment (baseline), after 12-weeks treatment). 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 NCT05890846, 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 2 Apr 2024.