active iTBS treatment: Participants will undergo three iTBS sessions per day, with 1800 pulses per session, over a 12-week period. Individualized targets will be generated using the pBFS technique.
sham iTBS treatment: Participants will undergo three iTBS sessions per day, with 1800 pulses per session, over a 12-week period. Sham stimulation will be delivered through a sham coil with the identical appearance as real coil. Individualized targets will be generated using the pBFS technique.
Study summary
The aim of this trial is to assess the efficacy and safety of precision neuromodulation for alleviating core symptoms in patients with autism spectrum disorder (ASD) who also have intellectual or developmental delay. The neuromodulation will be administered using intermittent theta burst stimulation (iTBS) targeting the left dorsolateral prefrontal cortex (DLPFC), guided by personalized Brain Functional Sector (pBFS) technology.
Eligibility
Sex
ALL
Min age
6 Years
Max age
30 Years
Healthy volunteers
No
Inclusion Criteria:
* 6-30 years old
* Have the diagnosis of autism spectrum disorder
* ADOS-2 score is higher than the ASD cut-offs
* Comorbid with intelligent disorder, IQ/DQ \< 70
* Primary environmental language is Chinese
* Participant's parents or other legal guardians give informed consent
Exclusion Criteria:
* Genetic Disorders, such as (e.g., Down syndrome, Fragile X syndrome, Rett syndorme), Current or history of severe ADHD, tourette syndrome, psychotic disorders (e.g., schizophrenia, schizoaffective disorder, bipolar disorder)
* Severe self-injury or suicidal behavior exhibited within the past year
* Significant visual, auditory, deafness or motor disability that prevent them from following study procedures
* Current or history diagnosis of epilepsy
* Known severe physical diseases, particularly those affecting the brain
* Metal implantation contradicted by MRI or TMS, such as artificial cardiac pacemakers, stents, cochlear implants
* Respiratory or circulatory conditions increasing sedation risk, such as Apnea syndrome, severe snoring, or other relevant diseases
* All legal guardians are illiterate, unable to read informed documents or complete questionnaires independently
* Received transcranial magnetic stimulation (TMS), transcranial current stimulation (tCS), focused ultrasound (FUS), or other neuromodulation treatment in the last 3 months
* Current participation in other clinical trials
Primary outcome measure(s)
ADOS-2 SA CSS score change after treatment — Pre-treatment (baseline), post-treatment (12-week) The score changes of ADOS-2 SA CSS (Autism Diagnostic Observation Scale, 2nd edition, social affect domain, calibrated severity score) at 12-week from baseline. Higher scores mean a worse outcome.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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