Autism Spectrum DisorderNCT06950437
pBFS Guided aiTBS Over Language Network for ASD Child
A study testing active iTBS and speech therapy in people with Autism Spectrum Disorder and Language Delay, run by Beijing Changping Tianhe Research Institute of Brain Science at 1 site in China.
Trial summary
The aim of this trial is to evaluate the efficacy and safety of precision neuromodulation in improving language ability in children with autism spectrum disorder (ASD) who also have language development delay. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Autism Spectrum Disorder, Language Delay
- What is being tested?
- active iTBS and speech therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 25 Apr 2025to 1 Jun 2027
- Phase
- Interventional
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 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Professionally diagnosed with ASD per DSM - 5 criteria.
- Aged 3 - 6.5 years, either gender.
- ADOS-2 results meet ASD standard cut - off.
- SCQ score: ≥15 (age ≥ 4 years) or ≥11 (age < 4 years).
- Co-existing language disorder not explaining ASD symptoms. No organic speech organ lesions. CNBS-R2016 and CLAS-TP language-related equivalent age > 18 months; any CLAS-TP dimension score < 6.
- Mandarin is the daily communication language.
- May have intellectual/global developmental delay not explaining ASD symptoms.
- Guardians volunteer, can cooperate in treatment and sign informed consent.
Who cannot join
- Identified genetic pathogenic factors; current/past comorbid severe disorders (ADHD, Tourette's, etc.).
- Serious self-harm in the past year.
- Severe sensory/motor disorders precluding cooperation.
- History of epileptic seizures.
- Serious organic diseases, especially brain related.
- Contraindications for MRI/TMS (metal/implants).
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- Respiratory/circulatory diseases with sedation risk.
- Illiterate guardians unable to handle informed consent/questionnaires.
- Received neuromodulation in the past 3 months.
- Currently in other clinical trials.
- Deemed unfit by the researcher.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University Sixth Hospital
Beijing
Li Yang
About this study
Official title: Transcranial Magnetic Stimulation Guided by Personalized Brain Functional Sectors (pBFS) for Language Deficit Comorbid in Autism Spectrum Disorder Child: a Multi-center, Randomized, Sham-controlled Trial
The aim of this trial is to evaluate the efficacy and safety of precision neuromodulation in improving language ability in children with autism spectrum disorder (ASD) who also have language development delay. The neuromodulation will be delivered using the accelerated intermittent theta burst stimulation (aiTBS) protocol, targeting the language network in the left superior frontal gyrus (SFG), guided by personalized Brain Functional Sector (pBFS) technology.
Read the detailed description
Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder often accompanied by language delay. Emerging evidence indicates that Transcranial Magnetic Stimulation (TMS) has been effective in restoring language ability in post-stroke aphasia, but its efficacy in developmental language disorders remains unknown.
By leveraging the personalized Brain Functional Sector (pBFS) technique and task-free functional MRI scans, we can accurately locate the individual language function brain network. Considering the accessibility and comfort of neuromodulation, we will stimulate the language network node in the superior frontal gyrus (SFG) for 12 weeks.
In this study, participants meeting the inclusion and exclusion criteria will be randomly assigned to either the active or sham iTBS (intermittent theta burst stimulation) groups at a ratio of 2:1. The treatment protocol lasts for 12 weeks, with sessions held 5 days a week and 3 iTBS sessions over the SFG per day. The inter-session interval is set at 50 minutes, along with speech therapy. Clinical evaluations focusing on language and ASD symptoms will be conducted at baseline, after the 12-week treatment period, and at 24-week follow-up after the start of treatment.
- Conditions
- Autism Spectrum Disorder, Language Delay
- Being tested
- active iTBS, Sham iTBS, speech therapy
- Keywords
- ASD, language delay, aiTBS, precision neuromodulation
- Medical subject headings
- Autism Spectrum Disorder, Language Development Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active iTBSDevice
Participants will undergo three iTBS sessions per day, with 1800 pulses per session, over a 12-week period. Individualized targets will be generated using the pBFS technique.
Sham iTBSDevice
Participants will undergo three sham iTBS sessions per day, with 1800 pulses per session, over a 12-week period. Sham stimulation will be delivered through a sham coil with the identical appearance as real coil. Individualized targets will be generated using the pBFS technique.
speech therapyBehavioural
Speech therapy will be delivered between iTBS/sham sessions. Two 30-minutes trainings every day.
| Study group | Role | What they receive |
|---|---|---|
| active iTBS group | Experimental | active iTBS over SFG Receives: Device: active iTBS; Behavioral: speech therapy |
| Sham group | Sham comparator | sham iTBS over SFG Receives: Device: Sham iTBS; Behavioral: speech therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
CLAS-TP score change after treatment
The score changes of combined CLAS-TP (Child Language Assessment Scale - Test for Preschoolers) score at 12-week from baseline. Higher scores mean a better outcome.
Measured: Pre-treatment (baseline), post-treatment (12-week)
Secondary outcomes (4)
CLAS-TP total score change from baseline to follow-up
Higher scores mean a better outcome.
Measured: Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)
CLAS-TP subscale score change from baseline to follow-up
For the story comprehension subscale, only participants who had non-zero point were included.
Higher scores mean a better outcome.
Measured: Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)
WPPSI language score change from baseline to follow-up
Higher scores mean a better outcome.
Measured: Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)
ADOS-2 SA score change from baseline to follow-up
Higher scores mean a worse outcome.
Measured: Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start25 Apr 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Jun 2027 (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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Changping Tianhe Research Institute of Brain Science
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Sixth Hospital, Shanghai Sunshine Rehabilitation Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06950437
- Sponsor's protocol ID
- NGASD002DMC_150
- Status last verified
- Feb 2025
- First submitted
- 10 Mar 2025
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided