NCT06950437Recruiting
pBFS Guided aiTBS Over Language Network for ASD Child
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
Source: ClinicalTrials.gov · Last updated 11 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 10 Mar 2025
- Start date
- 25 Apr 2025
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Beijing Changping Tianhe Research Institute of Brain Science
- Diseases
- Autism
- NCT number
- NCT06950437
What you commit to
- Study type: Interventional
- Planned participants: 150
- From 25 Apr 2025 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindications for MRI/TMS (metal/implants).
- Received neuromodulation in the past 3 months.
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 3 years to 6 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University Sixth Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.