Therapeutic Intervention Effects of rTMS on Children With Autism Spectrum Disorder
Primary Purpose
Autism
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Applied high amplitude repeated transcranial magnetic stimulation
Applied low amplitude repeated transcranial magnetic stimulation
Sponsored by
About this trial
This is an interventional basic science trial for Autism focused on measuring autism, Brain Plasticity, transcranial magnetic stimulation, Magnetic Resonance Imaging, eye movement, gut microbiome
Eligibility Criteria
Inclusion Criteria:
- Age range from 2 to 8 years old. Clinical DSM-IV diagnosis of autism.
Exclusion Criteria:
- Subjects with other neurodevelopmental diseases Subjects with contraindications to MRI.
Sites / Locations
- School of Life Science and Technology, University of Electronic Science and TechnologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
High amplitude repeated transcranial magnetic stimulation
Low amplitude repeated transcranial magnetic stimulation
healthy control group
Arm Description
Applied high amplitude repeated transcranial magnetic stimulation
Applied low amplitude repeated transcranial magnetic stimulation
No intervention
Outcomes
Primary Outcome Measures
The gray matter volume of children with autism at baseline and after repeated transcranial magnetic stimulation intervention as assessed by magnetic resonance imaging.
Longitudinal study of the gray matter volume will be conducted in children with autism at baseline and after repeated transcranial magnetic stimulation intervention based on structural magnetic resonance image. Longitudinal effect of repeated transcranial magnetic stimulation intervention on brain structure in children with autism will be assessed by Voxel-based morphometry analysis for gray matter volume changes.
Secondary Outcome Measures
The functional connectivity of whole brain of whole brain in children with autism with repeated transcranial magnetic stimulation intervention as assessed by functional magnetic resonance imaging.
Longitudinal study of the functional connectivity will be conducted in children with autism at baseline and after repeated transcranial magnetic stimulation intervention based on resting-state functional magnetic resonance image
Full Information
NCT ID
NCT05140356
First Posted
November 3, 2021
Last Updated
November 21, 2021
Sponsor
University of Electronic Science and Technology of China
1. Study Identification
Unique Protocol Identification Number
NCT05140356
Brief Title
Therapeutic Intervention Effects of rTMS on Children With Autism Spectrum Disorder
Official Title
Effects of Repetitive Transcranial Magnetic Stimulation (rTMS) on Neural Mechanisms and Cognitive Functions of Children With Autism Spectrum Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Electronic Science and Technology of China
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Autism spectrum disorder (ASD) is a common and complex neurodevelopmental disorder, which is characterized by impairments of social communication, social reciprocity, as well as restricted and repetitive behaviors (RRB). The unclear pathogenesis of ASD, its increasing prevalence, and its poor clinical diagnosis and treatment effect have caused a serious economic and mental burden on patients and their families. As a new non-invasive neuroelectrophysiological technique, transcranial magnetic stimulation (TMS) has been used more and more in the interventional treatment of autism. The current project aims to explore the influence of TMS on brain plasticity in autism by using TMS for interventional treatment of autism and provide guidelines for the intervention and treatment of autism by evaluating the efficiency of these methods.
Detailed Description
Autism spectrum disorder (ASD) is a common and complex neurodevelopmental disorder, which is characterized by impairments of social communication, social reciprocity, as well as restricted and repetitive behaviors (RRB). The unclear pathogenesis of ASD, its increasing prevalence, and its poor clinical diagnosis and treatment effect have caused a serious economic and mental burden on patients and their families. As a new non-invasive neuroelectrophysiological technique, transcranial magnetic stimulation (TMS) has been used more and more in the interventional treatment of autism. The current project aims to explore the influence of TMS on brain plasticity in autism by using TMS for interventional treatment of autism and provide guidelines for the intervention and treatment of autism by evaluating the efficiency of these methods. Investigators conduct a randomized, double-blind, controlled TMS trial and collect the participants' stool samples and sequence the gut microbiome before the first magnetic resonance imaging(MRI) scan. Besides, investigators collect brain imaging data, eye movement data and clinical scale score before and after TMS trial to explore the changes of TMS treatment on clinical behavior and brain plasticity and provide guidelines for the intervention and treatment of autism.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism
Keywords
autism, Brain Plasticity, transcranial magnetic stimulation, Magnetic Resonance Imaging, eye movement, gut microbiome
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High amplitude repeated transcranial magnetic stimulation
Arm Type
Experimental
Arm Description
Applied high amplitude repeated transcranial magnetic stimulation
Arm Title
Low amplitude repeated transcranial magnetic stimulation
Arm Type
Experimental
Arm Description
Applied low amplitude repeated transcranial magnetic stimulation
Arm Title
healthy control group
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Device
Intervention Name(s)
Applied high amplitude repeated transcranial magnetic stimulation
Intervention Description
Each mode required 20 stimuli(100%RMT) for 20 minutes each time, 5 times a week
Intervention Type
Device
Intervention Name(s)
Applied low amplitude repeated transcranial magnetic stimulation
Intervention Description
Each mode required 20 stimuli(15%RMT) for 20 minutes each time, 5 times a week
Primary Outcome Measure Information:
Title
The gray matter volume of children with autism at baseline and after repeated transcranial magnetic stimulation intervention as assessed by magnetic resonance imaging.
Description
Longitudinal study of the gray matter volume will be conducted in children with autism at baseline and after repeated transcranial magnetic stimulation intervention based on structural magnetic resonance image. Longitudinal effect of repeated transcranial magnetic stimulation intervention on brain structure in children with autism will be assessed by Voxel-based morphometry analysis for gray matter volume changes.
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
The functional connectivity of whole brain of whole brain in children with autism with repeated transcranial magnetic stimulation intervention as assessed by functional magnetic resonance imaging.
Description
Longitudinal study of the functional connectivity will be conducted in children with autism at baseline and after repeated transcranial magnetic stimulation intervention based on resting-state functional magnetic resonance image
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age range from 2 to 8 years old. Clinical DSM-IV diagnosis of autism.
Exclusion Criteria:
Subjects with other neurodevelopmental diseases Subjects with contraindications to MRI.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huafu Chen
Email
chenhf@uestc.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Huafu Chen, Study Principal Investigator
Email
chenhf@uestc.edu.cn
Facility Information:
Facility Name
School of Life Science and Technology, University of Electronic Science and Technology
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610054
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huafu Chen
Email
chenhf@uestc.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Therapeutic Intervention Effects of rTMS on Children With Autism Spectrum Disorder
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