China Rehabilitation Research Center
Beijing, China
NCT Number: NCT07515261
This study will evaluate the feasibility and preliminary efficacy of pBFS-guided TMS treatment at DMPFC in autism spectrum disorder comorbid with language delay.
Looking for future studies?
Notify Me6 year–30 year
All sexes
Interventional
Not applicable
Beijing, China
Autism spectrum disorder is a neurodevelopmental disorder characterized by impaired social communication and repetitive behaviors, often co-occurring with language delay. Using the personalized Brain Functional Sectors (pBFS) technique, investigators could precisely identify individualized brain areas underlying language and social communication a based on the resting-state functional MRI data. The tailored TMS intervention target to language and default mode network which located in the left dorsal medial prefrontal cortex (DMPFC) will be selected for each participant.
The participants will receive active iTBS to the language network 5 days per week for 12 weeks. Functional MRI data will be collected pre-and post-treatment under sedation. Three behavioral evaluations will be taken pre-treatment, after 8-weeks treatment and after 12-weeks treatment.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Each participant will receive 1800 pulse active iTBS (100% RMT) in each session, 3 sessions per day, 5 days per week for 8 weeks.
Time frame: Pre-treatment (baseline), after 8 weeks treatment, immediately post-treatment
The score change of vocabulary acquisition scales (VAS) from the Wechsler Preschool and Primary Scale of Intelligence, Fourth Edition (WPPSI-IV) from baseline. Higher scores mean a better outcome.
Time frame: Pre-treatment (baseline), after 8 weeks treatment, immediately post-treatment
The social affect dimension score change of autism diagnostic observation scale, 2nd edition (ADOS-2) from baseline. Higher scores mean a worse outcome.
Time frame: Pre-treatment (baseline), after 8 weeks treatment, immediately post-treatment
The score change of receptive vocabulary (pointing) from the Wechsler Preschool and Primary Scale of Intelligence, Fourth Edition (WPPSI-IV) from baseline. Higher scores mean a better outcome.
Time frame: Pre-treatment (baseline), after 8 weeks treatment, immediately post-treatment
The score change of picture naming (naming) from the Wechsler Preschool and Primary Scale of Intelligence, Fourth Edition (WPPSI-IV) from baseline. Higher scores mean a better outcome.
Time frame: Pre-treatment (baseline), after 8 weeks treatment, immediately post-treatment
The social dimension score change of the Social Communication Questionnaire (SCQ) from baseline. Higher scores mean a worse outcome.
Time frame: Pre-treatment (baseline), after 8 weeks treatment, immediately post-treatment
The communication dimension score change of the Social Communication Questionnaire (SCQ) from baseline. Higher scores mean a worse outcome.
Time frame: Pre-treatment (baseline), after 8 weeks treatment, immediately post-treatment
The total score change of autism diagnostic observation scale, 2nd edition (ADOS-2) from baseline. Higher scores mean a worse outcome.
Time frame: Pre-treatment (baseline), after 8 weeks treatment, immediately post-treatment
The restricted and repetitive behavior score change of autism diagnostic observation scale, 2nd edition (ADOS-2) from baseline. Higher scores mean a worse outcome.
Time frame: Pre-treatment (baseline), after 8 weeks treatment, immediately post-treatment
The total score change of the Social Communication Questionnaire (SCQ) from baseline. Higher scores mean a worse outcome.
Time frame: Pre-treatment (baseline), after 8 weeks treatment, immediately post-treatment
The RRB dimension score change of the Social Communication Questionnaire (SCQ) from baseline. Higher scores mean a worse outcome.
Time frame: Pre-treatment (baseline), after 8 weeks treatment, immediately post-treatment
Score change of the child behavior checklist (CBCL) from baseline. Higher scores mean a worse outcome. Higher scores mean a worse outcome.
Changping Laboratory
Other
Repetitive Transcranial Magnetic Stimulation Guided by Personalized Brain Functional Sectors (pBFS) for Comorbid Autism Spectrum Disorder and Language Delay: an One-arm Pilot Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.