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Completed

NCT Number: NCT07515261

pBFS Guided Neuromodulation Over DMPFC for ASD Treatment: Pilot Study

This study will evaluate the feasibility and preliminary efficacy of pBFS-guided TMS treatment at DMPFC in autism spectrum disorder comorbid with language delay.

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Key information

Age range

6 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

China Rehabilitation Research Center

Beijing, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 6-30 years old
  • Have the diagnosis of autism spectrum disorder
  • ADOS-2 score is higher than the ASD cut-offs
  • Have language development delay (the WISC-4 Verbal Comprehension Index lower than 70)
  • Capacity to follow the study procedures, including fMRI scan under sedation, assessment, and rehabilitation training
  • Participant's parents or other legal guardians give informed consent

Exclusion criteria

  • Current or history of psychotic disorders, such as schizophrenia, schizoaffective disorder, bipolar disorder
  • Severe self-injury or suicidal behavior presented in the last 1 year
  • Severe visual, auditory, or motor disability that interferes with any study procedure
  • Current, history or family history of epilepsy
  • Known severe physical diseases, such as congenital heart defect, traumatic brain injury
  • Metal implantations, which are contradicted by MRI or TMS, such as artificial cardiac pacemakers, stents, cochlear implants
  • Received TMS, tCS, FUS, or other neuromodulation treatment in the last 3 months
  • Currently participating in other clinical trials

Treatment and study plan

Active iTBS

Device

Each participant will receive 1800 pulse active iTBS (100% RMT) in each session, 3 sessions per day, 5 days per week for 8 weeks.

Primary outcomes

  1. Language score change

    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.

  2. ADOS-2 SA score change

    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.

Secondary outcomes

  1. Receptive vocabulary score change

    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.

  2. Expressive language score change

    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.

  3. SCQ S score change

    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.

  4. SCQ C score change

    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.

Other outcomes

  1. ADOS-2 total score change

    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.

  2. ADOS-2 RRB score change

    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.

  3. SCQ total score change

    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.

  4. SCQ R score change

    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.

  5. CBCL score change

    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.

Sponsors and collaborators

Lead sponsor

Changping Laboratory

Other

Collaborators

  • China Rehabilitation Research Center
  • Henan Provincial People's Hospital

Registry information

Official study title

Repetitive Transcranial Magnetic Stimulation Guided by Personalized Brain Functional Sectors (pBFS) for Comorbid Autism Spectrum Disorder and Language Delay: an One-arm Pilot Study

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 7, 2026
Registry last updated
Apr 7, 2026

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.