pBFS Guided aiTBS Over Language Network for ASD Child
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-6
SponsorBeijing Changping Tianhe Research Institute of Brain Science
About this trial
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
Qualifiers
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).
Disqualifiers
Identified genetic pathogenic factors; current/past comorbid severe disorders (ADHD, Tourette's, etc.).
Serious self-harm in the past year.
Severe sensory/motor disorders precluding cooperation.
History of epileptic seizures.
Trial design
Treatments tested in this trial
- active iTBS
- Sham iTBS
- speech therapy
Treatment groups
150 Participants
are divided into 2 treatment groupsSponsors and collaborators
Beijing Changping Tianhe Research Institute of Brain Science
Lead sponsor
Peking University Sixth Hospital
Collaborator
Shanghai Sunshine Rehabilitation Center
Collaborator
Source ClinicalTrials.gov