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pBFS Guided Precision Neuromodulation Treatment for ASD

Primary Purpose

Autism Spectrum Disorder

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
active iTBS
sham iTBS
Sponsored by
Changping Laboratory
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring TMS, fMRI, ASD, personalized

Eligibility Criteria

6 Years - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 parents or other legal guardians give informed consent Exclusion Criteria: Current or history of psychotic disorders, such as schizophrenia, 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 defects, 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

Sites / Locations

  • China Rehabilitation Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Sham Comparator

Sham Comparator

Arm Label

DLPFC group

DMPFC group

Sham to DLPFC group

Sham to DMPFC group

Arm Description

Active iTBS will be delivered to the left DLPFC.

Active iTBS will be delivered to the left DMPFC.

Sham iTBS will be delivered to left DLPFC.

Sham iTBS will be delivered to left DMPFC.

Outcomes

Primary Outcome Measures

ADOS-2 SA change
The social affect (SA) dimension score change of autism diagnostic observation scale, 2nd edition (ADOS-2) from baseline

Secondary Outcome Measures

ADOS-2 total score change
The total score change of autism diagnostic observation scale, 2nd edition (ADOS-2) from baseline
CBCL score change
Score change of the child behavior checklist (CBCL) from baseline

Full Information

First Posted
February 8, 2023
Last Updated
May 26, 2023
Sponsor
Changping Laboratory
Collaborators
China Rehabilitation Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT05735262
Brief Title
pBFS Guided Precision Neuromodulation Treatment for ASD
Official Title
Personalized Brain Functional Sectors (pBFS) Guided Precision Neuromodulation Treatment for Autism Spectrum Disorder (ASD): a Single-center, Sham-controlled, Double-blinded, Randomized Clinical Trial Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 7, 2023 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Changping Laboratory
Collaborators
China Rehabilitation Research Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study aims to evaluate the neuromodulation (i.e., iTBS) effectiveness for treating autism spectrum disorder (ASD) by targeting at the pBFS-guided executive function brain network or social brain network.
Detailed Description
Autism spectrum disorder is characterized by executive function deficiency and social interaction difficulty. Using the developed technique, personalized brain functional sectors (pBFS), we could precisely identify individualized brain function networks based on the resting-state functional MRI scan. A tailored dorsal lateral prefrontal cortex (DLPFC) region situated within the executive function network and a tailored dorsal medial prefrontal cortex (DMPFC) region situated within the social network will be selected as intervention targets. The participants will be equally randomized to the following three groups, active iTBS to the left DLPFC, active iTBS to the left DMPFC, and sham iTBS to either the left DLPFC or left DMPFC at a ratio of 2:2:1:1. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
TMS, fMRI, ASD, personalized

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DLPFC group
Arm Type
Experimental
Arm Description
Active iTBS will be delivered to the left DLPFC.
Arm Title
DMPFC group
Arm Type
Experimental
Arm Description
Active iTBS will be delivered to the left DMPFC.
Arm Title
Sham to DLPFC group
Arm Type
Sham Comparator
Arm Description
Sham iTBS will be delivered to left DLPFC.
Arm Title
Sham to DMPFC group
Arm Type
Sham Comparator
Arm Description
Sham iTBS will be delivered to left DMPFC.
Intervention Type
Device
Intervention Name(s)
active iTBS
Intervention Description
Each participant will receive 1800 pulse active iTBS (100% RMT) in each session, 3 sessions per day, 5 days per week for 8 weeks.
Intervention Type
Device
Intervention Name(s)
sham iTBS
Intervention Description
Each participant will receive 1800 pulse sham iTBS (100% RMT) in each session, 3 sessions per day, 5 days per week for 8 weeks.
Primary Outcome Measure Information:
Title
ADOS-2 SA change
Description
The social affect (SA) dimension score change of autism diagnostic observation scale, 2nd edition (ADOS-2) from baseline
Time Frame
Pre-treatment (baseline), immediately post-treatment
Secondary Outcome Measure Information:
Title
ADOS-2 total score change
Description
The total score change of autism diagnostic observation scale, 2nd edition (ADOS-2) from baseline
Time Frame
Pre-treatment (baseline), immediately post-treatment
Title
CBCL score change
Description
Score change of the child behavior checklist (CBCL) from baseline
Time Frame
Pre-treatment (baseline), immediately post-treatment
Other Pre-specified Outcome Measures:
Title
SRS-2 score change
Description
Sore change of the Social Responsiveness Scale, 2nd edition (SRS-2) from baseline
Time Frame
Pre-treatment (baseline), immediately post-treatment
Title
RBS-R score change
Description
Score change of the Repetitive Behavior Scale-Revised (RBS-R) from baseline
Time Frame
Pre-treatment (baseline), immediately post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 parents or other legal guardians give informed consent Exclusion Criteria: Current or history of psychotic disorders, such as schizophrenia, 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 defects, 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qi Liu
Phone
010-80726688
Email
a0000153@cpl.ac.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hesheng Liu, Ph.D.
Organizational Affiliation
Changping Laboratory
Official's Role
Study Chair
Facility Information:
Facility Name
China Rehabilitation Research Center
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hao Zhang

12. IPD Sharing Statement

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pBFS Guided Precision Neuromodulation Treatment for ASD

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