Using targeted brain stimulation to improve language skills in children with autism

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

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

• Phase: NA
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 3 Years to 6 Years
• Sex: All
• Sponsor: Beijing Changping Tianhe Research Institute of Brain Science (other)
• Locations: 1 site (Beijing)
• Trial ID: NCT06950437 on ClinicalTrials.gov

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.

Who should consider this trial

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.

Not a fit: Patients with severe comorbid disorders, significant self-harm history, or contraindications for MRI/TMS will not benefit from this study.

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 performed: While TMS has shown promise in treating post-stroke aphasia, its application in developmental language disorders like ASD is relatively novel and untested.

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.

Where this trial is running

Beijing

• Peking University Sixth Hospital — Beijing, China (RECRUITING)

Study contacts

• Study coordinator: Xinyu Duan

Conditions: Autism Spectrum Disorder, Language Delay, ASD, language delay, aiTBS, precision neuromodulation