Autism Spectrum Disorder With Language DelayNCT07515261
pBFS Guided Neuromodulation Over DMPFC for ASD Treatment: Pilot Study
A study testing active iTBS in people with Autism Spectrum Disorder With Language Delay, run by Changping Laboratory at 1 site in China.
Trial summary
This study will evaluate the feasibility and preliminary efficacy of pBFS-guided TMS treatment at DMPFC in autism spectrum disorder comorbid with language delay. Read more about this study
- Who is it for?
- Ages 6 to 30 years
- Conditions the study is for
- Autism Spectrum Disorder With Language Delay
- What is being tested?
- active iTBS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteChina
- Study dates
- 10 Mar 2023to 1 May 2024
- 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
- Have language development delay (the WISC-4 Verbal Comprehension Index lower than 70)
- 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, schizoaffective disorder, 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 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
1 site in 1 country.
About this study
Official title: Repetitive Transcranial Magnetic Stimulation Guided by Personalized Brain Functional Sectors (pBFS) for Comorbid Autism Spectrum Disorder and Language Delay: an One-arm Pilot Study
This study will evaluate the feasibility and preliminary efficacy of pBFS-guided TMS treatment at DMPFC in autism spectrum disorder comorbid with language delay.
Read the detailed description
Autism spectrum disorder is a neurodevelopmental disorder characterized by impaired social communication and repetitive behaviors, often co-occurring with language delay. Using the personalized Brain Functional Sectors (pBFS) technique, investigators could precisely identify individualized brain areas underlying language and social communication a based on the resting-state functional MRI data. The tailored TMS intervention target to language and default mode network which located in the left dorsal medial prefrontal cortex (DMPFC) will be selected for each participant.
The participants will receive active iTBS to the language network 5 days per week for 12 weeks. Functional MRI data will be collected pre-and post-treatment under sedation. Three behavioral evaluations will be taken pre-treatment, after 8-weeks treatment and after 12-weeks treatment.
- Being tested
- active iTBS
- Keywords
- TMS, personalized medicine, ASD, LD
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.
| Study group | Role | What they receive |
|---|---|---|
| active iTBS group | Experimental | Active iTBS will be delivered to the tailored DMPFC target. Receives: Device: active iTBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Language score change
The score change of vocabulary acquisition scales (VAS) from the Wechsler Preschool and Primary Scale of Intelligence, Fourth Edition (WPPSI-IV) from baseline. Higher scores mean a better outcome.
Measured: Pre-treatment (baseline), after 8 weeks treatment, immediately post-treatment
ADOS-2 SA score change
The social affect dimension score change of autism diagnostic observation scale, 2nd edition (ADOS-2) from baseline. Higher scores mean a worse outcome.
Measured: Pre-treatment (baseline), after 8 weeks treatment, immediately post-treatment
Secondary outcomes (4)
Receptive vocabulary score change
The score change of receptive vocabulary (pointing) from the Wechsler Preschool and Primary Scale of Intelligence, Fourth Edition (WPPSI-IV) from baseline. Higher scores mean a better outcome.
Measured: Pre-treatment (baseline), after 8 weeks treatment, immediately post-treatment
Expressive language score change
The score change of picture naming (naming) from the Wechsler Preschool and Primary Scale of Intelligence, Fourth Edition (WPPSI-IV) from baseline. Higher scores mean a better outcome.
Measured: Pre-treatment (baseline), after 8 weeks treatment, immediately post-treatment
SCQ S score change
The social dimension score change of the Social Communication Questionnaire (SCQ) from baseline. Higher scores mean a worse outcome.
Measured: Pre-treatment (baseline), after 8 weeks treatment, immediately post-treatment
SCQ C score change
The communication dimension score change of the Social Communication Questionnaire (SCQ) from baseline. Higher scores mean a worse outcome.
Measured: Pre-treatment (baseline), after 8 weeks treatment, 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 posted7 Apr 2026
- Study start10 Mar 2023
- Primary completion27 Feb 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum Disorder With Language DelayStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changping Laboratory
- Sponsor type
- University, hospital or other
- Collaborators
- China Rehabilitation Research Center, Henan Provincial People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07515261
- Sponsor's protocol ID
- CPASD1armDM20
- Status last verified
- Mar 2026
- First submitted
- 31 Mar 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- 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 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repetitive Transcranial Magnetic Stimulation Guided by Personalized Brain Functional Sectors (pBFS) for Comorbid Autism Spectrum Disorder and Language Delay: an One-arm Pilot Study
- ClinicalTrials.gov ID
- NCT07515261
- Acronym / sponsor ID
- CPASD1armDM20
- Keywords
- TMS, personalized medicine, ASD, LD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Changping LaboratoryUniversity, hospital or other
- Collaborators
- China Rehabilitation Research Center, Henan Provincial People's Hospital
- Study start
- 10 Mar 2023 (actual)
- Primary completion
- 27 Feb 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 7 Apr 2026 (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 feasibility and preliminary efficacy of pBFS-guided TMS treatment at DMPFC in autism spectrum disorder comorbid with language delay.
Detailed description
Autism spectrum disorder is a neurodevelopmental disorder characterized by impaired social communication and repetitive behaviors, often co-occurring with language delay. Using the personalized Brain Functional Sectors (pBFS) technique, investigators could precisely identify individualized brain areas underlying language and social communication a based on the resting-state functional MRI data. The tailored TMS intervention target to language and default mode network which located in the left dorsal medial prefrontal cortex (DMPFC) will be selected for each participant.
The participants will receive active iTBS to the language network 5 days per week for 12 weeks. Functional MRI data will be collected pre-and post-treatment under sedation. Three behavioral evaluations will be taken pre-treatment, after 8-weeks treatment and after 12-weeks treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| active iTBS group | Experimental | Device: active iTBSActive iTBS will be delivered to the tailored DMPFC target. |
Who may qualify
- Ages
- 6 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 6-30 years old
- Have the diagnosis of autism spectrum disorder
- ADOS-2 score is higher than the ASD cut-offs
- Have language development delay (the WISC-4 Verbal Comprehension Index lower than 70)
- Capacity to follow the study procedures, including fMRI scan under sedation, assessment, and rehabilitation training
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 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 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 8 weeks. | Device | active iTBS group |
Primary outcome
Language score change
Time frame: Pre-treatment (baseline), after 8 weeks treatment, immediately post-treatment
The score change of vocabulary acquisition scales (VAS) from the Wechsler Preschool and Primary Scale of Intelligence, Fourth Edition (WPPSI-IV) from baseline. Higher scores mean a better outcome.
ADOS-2 SA score change
Time frame: Pre-treatment (baseline), after 8 weeks treatment, immediately post-treatment
The social affect dimension score change of autism diagnostic observation scale, 2nd edition (ADOS-2) from baseline. Higher scores mean a worse outcome.
4 secondary outcomes
Receptive vocabulary score change
Time frame: Pre-treatment (baseline), after 8 weeks treatment, immediately post-treatment
Expressive language score change
Time frame: Pre-treatment (baseline), after 8 weeks treatment, immediately post-treatment
SCQ S score change
Time frame: Pre-treatment (baseline), after 8 weeks treatment, immediately post-treatment
SCQ C score change
Time frame: Pre-treatment (baseline), after 8 weeks treatment, immediately post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- 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.
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 active iTBS in people with Autism Spectrum Disorder With Language Delay, 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 6 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: finished, as of the sponsor's last update on 7 Apr 2026. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Language score change (time frame: Pre-treatment (baseline), after 8 weeks treatment, immediately post-treatment). 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 7 Apr 2026.