Therapeutic Intervention Effects of rTMS on Children With Autism Spectrum Disorder

NCT05140356 | Unknown DMC

• 1 other identifier: UESTC-chenhuafulab-003
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism

Keywords

autism; Brain Plasticity; transcranial magnetic stimulation; Magnetic Resonance Imaging; eye movement; gut microbiome

Outcome Measures

Primary Outcomes (1)

• 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.

  through study completion, an average of 1 year

Secondary Outcomes (1)

• 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.

  through study completion, an average of 1 year

Study Arms (3)

High amplitude repeated transcranial magnetic stimulation

EXPERIMENTAL

Applied high amplitude repeated transcranial magnetic stimulation

Device: Applied high amplitude repeated transcranial magnetic stimulation

Low amplitude repeated transcranial magnetic stimulation

EXPERIMENTAL

Applied low amplitude repeated transcranial magnetic stimulation

Device: Applied low amplitude repeated transcranial magnetic stimulation

healthy control group

NO INTERVENTION

No intervention

Interventions

Applied high amplitude repeated transcranial magnetic stimulation DEVICE

Each mode required 20 stimuli(100%RMT) for 20 minutes each time, 5 times a week

High amplitude repeated transcranial magnetic stimulation

Applied low amplitude repeated transcranial magnetic stimulation DEVICE

Each mode required 20 stimuli(15%RMT) for 20 minutes each time, 5 times a week

Low amplitude repeated transcranial magnetic stimulation

Eligibility Criteria

• Age: 2 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age range from 2 to 8 years old. Clinical DSM-IV diagnosis of autism.

You may not qualify if:

• Subjects with other neurodevelopmental diseases Subjects with contraindications to MRI.

Sponsors & Collaborators

• University of Electronic Science and Technology of China: lead

Study Sites (1)

School of Life Science and Technology, University of Electronic Science and Technology

Chengdu, Sichuan, 610054, China

RECRUITING

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Huafu Chen

CONTACT

chenhf@uestc.edu.cn

Huafu Chen, Study Principal Investigator

CONTACT

chenhf@uestc.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: November 3, 2021
• First Posted: December 1, 2021
• Study Start: May 1, 2019
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: December 1, 2021

Record last verified: 2021-11

Locations

CN (1)