pBFS Guided Neuromodulation Over DMPFC for ASD Treatment: Pilot Study

March 31, 2026 updated by: Changping Laboratory

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • China Rehabilitation Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: active iTBS group
Active iTBS will be delivered to the tailored DMPFC target.
Device: active iTBS
Each participant will receive 1800 pulse active iTBS (100% RMT) in each session, 3 sessions per day, 5 days per week for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Pre-treatment (baseline), after 8 weeks treatment, immediately post-treatment
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.
Pre-treatment (baseline), after 8 weeks treatment, immediately post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Pre-treatment (baseline), after 8 weeks treatment, immediately post-treatment
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.
Pre-treatment (baseline), after 8 weeks treatment, immediately post-treatment
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.
Pre-treatment (baseline), after 8 weeks treatment, immediately post-treatment
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.
Pre-treatment (baseline), after 8 weeks treatment, immediately post-treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Pre-treatment (baseline), after 8 weeks treatment, immediately post-treatment
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.
Pre-treatment (baseline), after 8 weeks treatment, immediately post-treatment
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.
Pre-treatment (baseline), after 8 weeks treatment, immediately post-treatment
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.
Pre-treatment (baseline), after 8 weeks treatment, immediately post-treatment
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.
Pre-treatment (baseline), after 8 weeks treatment, immediately post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changping Laboratory

Collaborators

Henan Provincial People's Hospital
China Rehabilitation Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2023

Primary Completion (Actual)

February 27, 2024

Study Completion (Actual)

May 1, 2024

Study Registration Dates

First Submitted

March 31, 2026

First Submitted That Met QC Criteria

March 31, 2026

First Posted (Actual)

April 7, 2026

Study Record Updates

Last Update Posted (Actual)

April 7, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CPASD1armDM20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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