AutismNCT05140356
Therapeutic Intervention Effects of rTMS on Children With Autism Spectrum Disorder
A study testing Applied high amplitude repeated transcranial magnetic stimulation and Applied low amplitude repeated transcranial magnetic stimulation in people with Autism, run by University of Electronic Science and Technology of China at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 2 to 8 years
- Conditions the study is for
- Autism
- What is being tested?
- Applied high amplitude repeated transcranial magnetic stimulation and Applied low amplitude repeated transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2019to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age range from 2 to 8 years old. Clinical DSM-IV diagnosis of autism.
Who cannot join
- Subjects with other neurodevelopmental diseases Subjects with contraindications to MRI.
Trial locations and contacts
1 site in 1 country.
Huafu Chen contact
Huafu Chen, Study Principal Investigator contact
China1 site, 1 recruiting
- Recruiting
School of Life Science and Technology, University of Electronic Science and Technology
Chengdu, Sichuan, 610054
Huafu Chen, chenhf@uestc.edu.cn
About this study
Official title: Effects of Repetitive Transcranial Magnetic Stimulation (rTMS) on Neural Mechanisms and Cognitive Functions of Children With Autism Spectrum Disorder
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.
Read the 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.
- Conditions
- Autism
- Being tested
- Applied high amplitude repeated transcranial magnetic stimulation, Applied low amplitude repeated transcranial magnetic stimulation
- Keywords
- autism, Brain Plasticity, transcranial magnetic stimulation, Magnetic Resonance Imaging, eye movement, gut microbiome
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Applied high amplitude repeated transcranial magnetic stimulationDevice
Each mode required 20 stimuli(100%RMT) for 20 minutes each time, 5 times a week
Applied low amplitude repeated transcranial magnetic stimulationDevice
Each mode required 20 stimuli(15%RMT) for 20 minutes each time, 5 times a week
| Study group | Role | What they receive |
|---|---|---|
| High amplitude repeated transcranial magnetic stimulation | Experimental | Applied high amplitude repeated transcranial magnetic stimulation Receives: Device: Applied high amplitude repeated transcranial magnetic stimulation |
| Low amplitude repeated transcranial magnetic stimulation | Experimental | Applied low amplitude repeated transcranial magnetic stimulation Receives: Device: Applied low amplitude repeated transcranial magnetic stimulation |
| healthy control group | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start1 May 2019
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Electronic Science and Technology of China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huafu Chen, University of Electronic Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05140356
- Sponsor's protocol ID
- UESTC-chenhuafulab-003
- Status last verified
- Nov 2021
- First submitted
- 3 Nov 2021
- Last updated
- 1 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Repetitive Transcranial Magnetic Stimulation (rTMS) on Neural Mechanisms and Cognitive Functions of Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT05140356
- Acronym / sponsor ID
- UESTC-chenhuafulab-003
- Conditions
- Autism
- Keywords
- autism, Brain Plasticity, transcranial magnetic stimulation, Magnetic Resonance Imaging, eye movement, gut microbiome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Electronic Science and Technology of ChinaUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 1 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High amplitude repeated transcranial magnetic stimulation | Experimental | Device: Applied high amplitude repeated transcranial magnetic stimulationApplied high amplitude repeated transcranial magnetic stimulation |
| Low amplitude repeated transcranial magnetic stimulation | Experimental | Device: Applied low amplitude repeated transcranial magnetic stimulationApplied low amplitude repeated transcranial magnetic stimulation |
| healthy control group | No intervention | –No intervention |
Who may qualify
- Ages
- 2 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Age range from 2 to 8 years old. Clinical DSM-IV diagnosis of autism.
Key exclusion criteria (1 listed)
- Subjects with other neurodevelopmental diseases Subjects with contraindications to MRI.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Applied high amplitude repeated transcranial magnetic stimulationEach mode required 20 stimuli(100%RMT) for 20 minutes each time, 5 times a week | Device | High amplitude repeated transcranial magnetic stimulation |
| Applied low amplitude repeated transcranial magnetic stimulationEach mode required 20 stimuli(15%RMT) for 20 minutes each time, 5 times a week | Device | Low amplitude repeated transcranial magnetic stimulation |
Primary outcome
The gray matter volume of children with autism at baseline and after repeated transcranial magnetic stimulation intervention as assessed by magnetic resonance imaging.
Time frame: through study completion, an average of 1 year
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.
1 secondary outcome
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.
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huafu Chen contact
Huafu Chen, Study Principal Investigator contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Applied high amplitude repeated transcranial magnetic stimulation and Applied low amplitude repeated transcranial magnetic stimulation in people with Autism, run by University of Electronic Science and Technology of China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huafu Chen (chenhf@uestc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The gray matter volume of children with autism at baseline and after repeated transcranial magnetic stimulation intervention as assessed by magnetic resonance imaging. (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2021.