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.
Autism Spectrum Disorder (ASD) is a neurodevelopmental condition characterized by impaired social communication and repetitive behaviors. Unfortunately, evidence-based treatments have not proven effective for older individuals with low-functioning ASD, despite their significant need for intensive support. However, emerging evidence suggests that Transcranial Magnetic Stimulation (TMS) has been successful in treating various psychiatric and neurological disorders. Given the broad cognitive control dysfunction observed in ASD, targeting cognitive control function may offer a promising treatment approach. Leveraging the personalized Brain Functional Sector (pBFS) technique and task-free functional MRI scans, we can precisely locate the cognitive control function region within the left DLPFC, and follow-up at 24-week after initiation of treatment. In this study, participants who meet the inclusion and exclusion criteria will be randomly assigned to either active or sham iTBS (intermittent theta burst stimulation) groups at a ratio of 2:1. The treatment protocol consists of a 12-week duration, with sessions conducted 5 days per week and 3 sessions iTBS over DLPFC per day. The inter-session interval is set at 30 minutes. Clinical evaluations focusing on ASD core symptoms and related behavioral profiles will be conducted at baseline and after the 12-week treatment period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
215
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.
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.
Fujian Children's Hospital
Fuzhou, Fujian, China
RECRUITINGFujian Maternity and Child Health Hospital
Fuzhou, Fujian, China
RECRUITINGHebei Provincial Mental Health Center
Baoding, Hebei, China
ADOS-2 SA CSS score change after treatment
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.
Time frame: Pre-treatment (baseline), post-treatment (12-week)
ADOS-2 SA CSS score change from baseline to follow-up
The score changes of ADOS-2 SA CSS from baseline, to 12-week posttreatment and, to 24-week follow-up. Higher scores mean a worse outcome.
Time frame: Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)
Response rate in social ability after 12-week iTBS treatment
Treatment response is defined as improvement, i.e., at least 1-point decreased, in the ADOS-2 SA For ADOS-2 SA, higher scores means more severe symptom.
Time frame: Pre-treatment (baseline), post-treatment (12-week)
Response rate in social ability at 24-week follow-up
Treatment response is defined as improvement, i.e., at least 1-point decreased, in the ADOS-2 SA For ADOS-2 SA, higher scores means more severe symptom.
Time frame: Pre-treatment (baseline), follow-up (24-week)
ADOS-2 total CSS change with treatment
The ADOS-2 total CSS score change from baseline. Higher scores mean a worse outcome.
Time frame: Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)
SCQ score change with treatment
The SCQ (Social Communication Questionnaire) score change from baseline. Higher scores mean a worse outcome.
Time frame: Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)
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Xi'an TCM Hospital of Encephalopathy
Xi'an, Shaanxi, China
RECRUITINGJining Medical University
Jining, Shandong, China
RECRUITINGLinyi Hedong Rehabilitation Hospital
Linyi, Shandong, China
RECRUITINGCBCL score change with treatment
The CBCL (Child Behavior Checklist) score change from baseline. Higher scores mean a worse outcome.
Time frame: Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)
QoL score change with treatment
The QoL (quality of life) score change from baseline. Higher scores mean a worse outcome.
Time frame: Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)
AIM score change with treatment
The AIM (Autism Impact Measure) score change from baseline. Higher scores mean a worse outcome.
Time frame: Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)