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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06031948
Recruitment Status : Not yet recruiting
First Posted : September 11, 2023
Last Update Posted : September 11, 2023
Sponsor:
Collaborator:
Henan Provincial People's Hospital
Information provided by (Responsible Party):
Changping Laboratory

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Device: active iTBS Device: sham iTBS Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : October 1, 2023
Estimated Primary Completion Date : August 1, 2024
Estimated Study Completion Date : January 1, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 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.
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   30 Months to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06031948


Contacts
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Contact: Qi Liu, Ph.D. 010-80726688 a0000153@cpl.ac.cn

Sponsors and Collaborators
Changping Laboratory
Henan Provincial People's Hospital
Investigators
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Study Chair: Hesheng Liu, Ph.D. Changping Laboratory
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Changping Laboratory
ClinicalTrials.gov Identifier: NCT06031948    
Other Study ID Numbers: CPLASD2023HNC50
First Posted: September 11, 2023    Key Record Dates
Last Update Posted: September 11, 2023
Last Verified: September 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Changping Laboratory:
TMS
ASD
fMRI
personalized medicine
Additional relevant MeSH terms:
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Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders