Magnetic brain stimulation for language delay in children with autism
Tests magnetic brain stimulation with speech therapy in autistic children with language delay.
Plain-language title generated from the registry record
Registry title: pBFS Guided aiTBS Over Language Network for ASD Child
Key facts
- Where
- Beijing, ChinaSee the site
Could this be for you?
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?
Source: NCT06950437, who can take part
Where in China
- Peking University Sixth HospitalBeijing, ChinaTaking people
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?
Trial details
- Who runs it
- Beijing Changping Tianhe Research Institute of Brain Science
- Trial code
- NCT06950437
- Record updated
- 11 May 2025
- Original description
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 full original descriptionShow less
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.
Inclusion: 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.
Exclusion: 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.