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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 6
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Peking University Sixth Hospital
RECRUITING
Beijing
Contact Information
Primary
Xinyu Duan
xinyu.duan@neuralgalaxy.com
13691009590
Time Frame
Start Date: 2025-04-25
Estimated Completion Date: 2027-06-01
Participants
Target number of participants: 150
Treatments
Experimental: active iTBS group
active iTBS over SFG
Sham_comparator: Sham group
sham iTBS over SFG
Related Therapeutic Areas
Sponsors
Collaborators: Shanghai Yangzhi Rehabilitation Hospital, Peking University Sixth Hospital
Leads: Beijing Changping Tianhe Research Institute of Brain Science

This content was sourced from clinicaltrials.gov