NCT06950437 pBFS Guided aiTBS Over Language Network for ASD Child
| NCT ID | NCT06950437 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beijing Changping Tianhe Research Institute of Brain Science |
| Condition | Autism Spectrum Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-04-25 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2025-04-25 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06950437 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 6 Years, studying Autism Spectrum Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06950437 currently recruiting?
Yes, NCT06950437 is actively recruiting participants. Contact the research team at xinyu.duan@neuralgalaxy.com for enrollment information.
Where is the NCT06950437 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06950437 clinical trial?
NCT06950437 is sponsored by Beijing Changping Tianhe Research Institute of Brain Science. The trial plans to enroll 150 participants.