Precision TMS Treatment Guided by Personalized Brain Functional Sectors (pBFS) for ASD

April 1, 2024 updated by: Changping Laboratory

Personalized Brain Functional Sectors (pBFS) Guided Transcranial Magnetic Stimulation (TMS) Treatment for Autism Spectrum Disorder (ASD): a Sham-controlled, Double-blinded, Randomized Clinical Trial Study

This study will evaluate the efficacy and safety of pBFS-guided TMS treatment for the core symptom in autism spectrum disorder children, adolescents and young adults.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Autism spectrum disorder is a neurodevelopmental disorder characterized by impaired social communication and repetitive behaviors. Broad cognitive control function deficit in ASD suggested cognitive control function as a potential phenotype and treatment target. Using the personalized Brain Functional Sectors (pBFS) technique, investigators could precisely identify individualized brain areas underlying cognitive control function based on the task free functional MRI data. The tailored TMS intervention target to cognitive control function network which located in the left dorsal lateral prefrontal cortex (DLPFC) will be selected for each participant by a blinded researcher.

The participants will be equally randomized to the active iTBS to the cognitive control function network, and sham iTBS at a ratio of 2:1. Each participant will receive 5 days of treatment per week for 12 weeks. Functional MRI data under sedation will be collected pre-and post-treatment. Three behavioral evaluations will be taken pre-treatment, after 8-weeks treatment and after 12-weeks treatment.

Study Type

Interventional

Enrollment (Estimated)

66

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 Contact

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • China Rehabilitation Research Center
        • Contact:
          • Hao Zhang, M.D.,Ph.D.
    • Henan
      • Zhengzhou, Henan, China
        • Recruiting
        • Henan Provincial People's Hospital
        • Contact:
          • Meiyun Wang, M.D.,Ph.D.

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:

  • Nearest age 6-30 years old
  • Have the diagnosis of autism spectrum disorder
  • ADOS-2 score is higher than the ASD cut-offs
  • Capacity to follow the study procedures, including fMRI scan under sedation, assessment, and rehabilitation training
  • Participant's parent or other legal guardian 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 one year
  • Severe visual, auditory, or motor disability that interferes with any study procedure
  • Current or history of seizure
  • 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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DLPFC group
Active iTBS will be delivered to the cognitive control network at left DLPFC.
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 12 weeks.
Behavioral: traditional 1on1 course
Between every two iTBS sessions, the participant will receive a personalized 30-minutes one-on-one behavioral course, 2 courses per day, 5 days per week for 12 weeks.
Sham Comparator: Sham group
Sham iTBS will be delivered to the cognitive control network at left DLPFC.
Behavioral: traditional 1on1 course
Between every two iTBS sessions, the participant will receive a personalized 30-minutes one-on-one behavioral course, 2 courses per day, 5 days per week for 12 weeks.
Device: sham iTBS
Each participant will receive 1800 pulse sham iTBS (100% RMT) in each session, 3 sessions per day, 5 days per week for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response rate after 12 weeks treatment
Time Frame: Pre-treatment (baseline), after 12-weeks treatment
Treatment response is defined as improvement, i.e., scores decreased, in both the social affect (SA) dimension score change of autism diagnostic observation scale, 2nd edition (ADOS-2) from baseline. For ADOS-2 SA, higher scores means more severe symptom.
Pre-treatment (baseline), after 12-weeks treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ADOS-2 SA score change
Time Frame: Pre-treatment (baseline), after 8-weeks treatment，after 12-weeks tretment
The ADOS-2 SA score changes from baseline. Higher scores mean a worse outcome.
Pre-treatment (baseline), after 8-weeks treatment，after 12-weeks tretment
SCQ score change
Time Frame: Pre-treatment (baseline), after 8-weeks treatment，after 12-weeks tretment
SCQ score change from baseline. Higher scores mean a worse outcome.
Pre-treatment (baseline), after 8-weeks treatment，after 12-weeks tretment
ADOS-2 total score change
Time Frame: Pre-treatment (baseline), after 8-weeks treatment，after 12-weeks tretment
The ADOS-2 total score change from baseline. Higher scores mean a worse outcome.
Pre-treatment (baseline), after 8-weeks treatment，after 12-weeks tretment
CBCL score change
Time Frame: Pre-treatment (baseline), after 8-weeks treatment，after 12-weeks tretment
Score change of the child behavior checklist (CBCL) from baseline. Higher scores mean a worse outcome.
Pre-treatment (baseline), after 8-weeks treatment，after 12-weeks tretment
SRS-2 score change
Time Frame: Pre-treatment (baseline), after 8-weeks treatment，after 12-weeks tretment
Score change of the Social Responsiveness Scale, 2nd edition (SRS-2) from baseline. Higher scores mean a worse outcome.
Pre-treatment (baseline), after 8-weeks treatment，after 12-weeks tretment
Response rate after 8 weeks treatment
Time Frame: Pre-treatment (baseline), after 8-weeks treatment
Treatment response is defined as improvement, i.e., scores decreased, in the social affect (SA) dimension score change of autism diagnostic observation scale, 2nd edition (ADOS-2) from baseline. For ADOS-2 SA, higher scores means more severe symptom.
Pre-treatment (baseline), after 8-weeks treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
SRS-2 score change
Time Frame: Pre-treatment (baseline), immediately post-treatment
Score change of the Social Responsiveness Scale, 2nd edition (SRS-2) from baseline. Higher scores mean a worse outcome.
Pre-treatment (baseline), immediately post-treatment
SCQ score change
Time Frame: Pre-treatment (baseline), immediately post-treatment
Score change of the Social Communication Questionnaire (SCQ) from baseline. Higher scores mean a worse outcome.
Pre-treatment (baseline), 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

Investigators

  • Study Chair: Hesheng Liu, Ph.D., Changping Laboratory

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)

June 25, 2022

Primary Completion (Estimated)

September 20, 2024

Study Completion (Estimated)

September 20, 2025

Study Registration Dates

First Submitted

May 26, 2023

First Submitted That Met QC Criteria

May 26, 2023

First Posted (Actual)

June 6, 2023

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPASD2023DL

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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