Using targeted brain stimulation to improve language skills in children with autism
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
Run by Beijing Changping Tianhe Research Institute of Brain Science · NCT06950437 · Data updated 2026-11-12
This study is testing if a special brain stimulation treatment can help young children with autism improve their language skills while they also receive speech therapy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 3 Years to 6 Years |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Beijing Changping Tianhe Research Institute of Brain Science Academic / other |
| Locations | 1 site (Beijing) |
| Status | Recruiting |
| Started | April 25, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | June 1, 2027 |
| Registry record updated | May 11, 2025 |
| Trial ID | NCT06950437 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 3 to 6.5 years with a professional diagnosis of ASD and co-existing language delays, who communicate in Mandarin.
✕Probably not a fit
Patients with severe comorbid disorders, significant self-harm history, or contraindications for MRI/TMS will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This trial evaluates the efficacy and safety of precision neuromodulation using accelerated intermittent theta burst stimulation (aiTBS) to enhance language abilities in children aged 3 to 6.5 years diagnosed with Autism Spectrum Disorder (ASD) and language delays. The treatment targets the language network in the left superior frontal gyrus, guided by personalized Brain Functional Sector (pBFS) technology. Participants will be randomly assigned to receive either active or sham stimulation over a 12-week period, combined with speech therapy, while clinical evaluations will assess language and ASD symptoms at multiple time points.
Why it matters
Potential benefit: If successful, this approach could significantly improve language development in children with ASD, enhancing their communication skills and overall quality of life.
How similar studies have gone: While TMS has shown promise in treating post-stroke aphasia, its application in developmental language disorders like ASD is relatively novel and untested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Professionally diagnosed with ASD per DSM - 5 criteria. 2. Aged 3 - 6.5 years, either gender. 3. ADOS-2 results meet ASD standard cut - off. 4. SCQ score: ≥15 (age ≥ 4 years) or ≥11 (age \< 4 years). 5. 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. 6. Mandarin is the daily communication language. 7. May have intellectual/global developmental delay not explaining ASD symptoms. 8. Guardians volunteer, can cooperate in treatment and sign informed consent. Exclusion Criteria: 1. Identified genetic pathogenic factors; current/past comorbid severe disorders (ADHD, Tourette's, etc.). 2. Serious self-harm in the past year. 3. Severe sensory/motor disorders precluding cooperation. 4. History of epileptic seizures. 5. Serious organic diseases, especially brain related. 6. Contraindications for MRI/TMS (metal/implants). 7. Respiratory/circulatory diseases with sedation risk. 8. Illiterate guardians unable to handle informed consent/questionnaires. 9. Received neuromodulation in the past 3 months. 10. Currently in other clinical trials. 11. Deemed unfit by the researcher.
Where it's running
-
Peking University Sixth Hospital
Beijing, China Recruiting
Study contacts
- Study coordinator: Xinyu Duan
- Email: xinyu.duan@neuralgalaxy.com
- Phone: 13691009590
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.