Clinical trial NCT05140356: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Autism
Keywords: autism
Brain Plasticity
transcranial magnetic stimulation
Magnetic Resonance Imaging
eye movement
gut microbiome
Lead sponsor: University of Electronic Science and Technology of China
Sponsor class: OTHER
First posted: 2021-12-01
Enrollment: 60
Sex: ALL
Minimum age (years): 2
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: The gray matter volume of children with autism at baseline and after repeated transcranial magnetic stimulation intervention as assessed by magnetic resonance imaging.
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: 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.
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Chengdu
country: China
facility: School of Life Science and Technology, University of Electronic Science and Technology
state: Sichuan
Study officials:
References: