Magnetic brain stimulation for language delay in children with autism
Tests magnetic brain stimulation with speech therapy in autistic children with language delay.
Key facts
- Who runs it
- Beijing Changping Tianhe Research Institute of Brain Science
- Where
- Beijing, ChinaSee the site
- Trial code
- Registry title
- pBFS Guided aiTBS Over Language Network for ASD Child
- Status
- Recruiting
- People taking part
- 150 people, planned
- Started
- 25 Apr 2025
- Expected to end
- 1 Jun 2027
- Type of study
- Interventional, 2 groupsOne group gets a sham (pretend) treatment, for comparison.
- Treatments tested
- active iTBS
- Sham iTBS
- speech therapy
- Record updated
- 11 May 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children aged 3 to 6.5 years with autism spectrum disorder and delayed language development. It tests a magnetic brain stimulation treatment for language.
- Age
- 3 to 6.5 years
- Sex
- Boys and girls can both join.
- Disease stage
- Autism spectrum disorder diagnosed by a professional, meeting the ADOS-2 cut-off, with a language disorder. Scores are set on the SCQ, CNBS-R2016 and CLAS-TP scales. An intellectual or global developmental delay may also be present.
- Earlier treatment
- Cannot have had brain stimulation (neuromodulation) in the past 3 months.
Main reasons for not taking part
- Known genetic cause or severe disorders such as ADHD or Tourette's
- History of epileptic seizures
- Metal or implants that rule out MRI or magnetic stimulation
- Serious physical disease, especially of the brain
- Currently in another clinical trial
The registry criteria, word for word
Show all 19 criteriaShow less
Who can take part
- 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 take part
- Contraindications for MRI/TMS (metal/implants)
- Received neuromodulation in the past 3 months
- Identified genetic pathogenic factors; current/past comorbid severe disorders (ADHD, Tourette's, etc.)
- Severe sensory/motor disorders precluding cooperation
- History of epileptic seizures
- Serious organic diseases, especially brain related
- Respiratory/circulatory diseases with sedation risk
- Serious self-harm in the past year
- Illiterate guardians unable to handle informed consent/questionnaires
- Currently in other clinical trials
- Deemed unfit by the researcher
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 3 and 6 years old?
Where in China
- Peking University Sixth HospitalBeijing, ChinaContact: Li YangTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- active iTBS groupTreatment being tested
active iTBS over SFG
Treatment: active iTBS and speech therapy
- Sham groupSham treatment, for comparison
sham iTBS over SFG
Treatment: Sham iTBS and speech therapy
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Plain-language title
- Magnetic brain stimulation for language delay in children with autismGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06950437, who can take part
- Record updated
- 11 May 2025