pBFS-guided Noninvasive Neuromodulation for Pre-school Children With ASD

September 4, 2023 updated by: Changping Laboratory

Personalized Brain Functional Sectors (pBFS) Guided Noninvasive Neuromodulation Treatment for Pre-school Children With Autism Spectrum Disorder (ASD): a Single-center, Double-blinded, Sham-Controlled, Randomized Clinical Trial Study

This randomized controlled trial aims to evaluate the efficacy and safeness of the pBFS-guided rTMS intervention for core symptom relief in pre-school children with autism spectrum disorder (ASD).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Autism spectrum disorder is a neurodevelopmental disorder, begins early in life. Using the personalized brain functional sectors (pBFS) technology, investigators could precisely identify individualized brain function networks based on the functional MRI scan. For each participant, two personalised TMS intervention targets will be chosen by blinded researcher. One executive function network target is located in the dorsal lateral prefrontal cortex (DLPFC) , and the other social function network target is located in the dorsal medial prefrontal cortex (DMPFC).

The participants will be equally randomized to the following four groups, active iTBS to the left DMPFC or the left DLPFC, and sham iTBS to either the left DMPFC or left DLPFC at a ratio of 2:2:1:1. Later analyses will combine the two sham groups as one control group. Each participant will receive 1800 pulse active or sham iTBS (100% RMT) in each session, 3 sessions daily, 5 days per week for 8 weeks, as well as background behavioral training between iTBS sessions. Pre-and post-treatment functional MRI data will be collected under sedation.

Study Type

Interventional

Enrollment (Estimated)

50

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

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

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 2.5-6 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 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: 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 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 8 weeks.
Experimental: DMPFC group
Active iTBS will be delivered to the left DMPFC.
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.
Sham Comparator: Sham to DMPFC group
Sham iTBS will be delivered to the left DMPFC.
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 8 weeks.
Sham Comparator: Sham to DLPFC group
Sham iTBS will be delivered to the left DLPFC.
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 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ADOS-2 SA change
Time Frame: Pre-treatment (baseline), immediately post-treatment
The social affect (SA) dimension score change of autism diagnostic observation scale, 2nd edition (ADOS-2) from baseline. Higher scores mean a worse outcome.
Pre-treatment (baseline), immediately post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ADOS-2 total score change
Time Frame: Pre-treatment (baseline), 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), immediately post-treatment
CBCL score change
Time Frame: Pre-treatment (baseline), immediately post-treatment
Score change of the child behavior checklist (CBCL) from baseline. Higher scores mean a worse outcome.
Pre-treatment (baseline), immediately post-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
RBS-R score change
Time Frame: Pre-treatment (baseline), immediately post-treatment
Score change of the Repetitive Behavior Scale-Revised (RBS-R) 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

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 (Estimated)

October 1, 2023

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

September 4, 2023

First Submitted That Met QC Criteria

September 4, 2023

First Posted (Actual)

September 11, 2023

Study Record Updates

Last Update Posted (Actual)

September 11, 2023

Last Update Submitted That Met QC Criteria

September 4, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPLASD2023HNC50

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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