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Therapeutic Intervention Effects of rTMS on Children With Autism Spectrum Disorder

NCT ID: NCT05140356

Last Updated: 2021-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Autism

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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High amplitude repeated transcranial magnetic stimulation

Applied high amplitude repeated transcranial magnetic stimulation

Group Type EXPERIMENTAL

Applied high amplitude repeated transcranial magnetic stimulation

Intervention Type DEVICE

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

Low amplitude repeated transcranial magnetic stimulation

Applied low amplitude repeated transcranial magnetic stimulation

Group Type EXPERIMENTAL

Applied low amplitude repeated transcranial magnetic stimulation

Intervention Type DEVICE

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

healthy control group

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Applied high amplitude repeated transcranial magnetic stimulation

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

Intervention Type DEVICE

Applied low amplitude repeated transcranial magnetic stimulation

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Electronic Science and Technology of China

OTHER

Sponsor Role lead

Responsible Party

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Huafu Chen

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Chengdu, Sichuan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Huafu Chen

Role: CONTACT

Email: [email protected]

Huafu Chen, Study Principal Investigator

Role: CONTACT

Email: [email protected]

Facility Contacts

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Huafu Chen

Role: primary

Other Identifiers

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UESTC-chenhuafulab-003

Identifier Type: -

Identifier Source: org_study_id