Autism Spectrum DisorderNCT05238298
Efficacy and Mechanism of rTMS in Children With ASD: an Open-label Clinical Trial
A study testing repetitive Transcranial Magnetic Stimulation in people with Autism Spectrum Disorder, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
This study is a 6-week open-label clinical trial involving 20 children aged 6-10 years with autism spectrum disorder. During the study, subjects received repeated transcranial magnetic stimulation（rTMS）intervention at the left primary motor cortex (M1) 5 times per day for 10 days. Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- repetitive Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 28 Jan 2022to 1 Apr 2022
- 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 6 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 6-10 years.
- Meeting the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Edition 5 (DSM-5) .
- Confirmed by the ADOS and/or ADI-R diagnostic tool.
- IQ ≥70.
- Informed consent.
Who cannot join
- Patients with metal implants .
- Patients with neurological diseases such as epilepsy .
- Patients requiring surgical treatment due to structural abnormalities indicated by brain MRI .
- Genetic or chromosomal abnormalities .
- Suffering from mental disorders (such as mood disorders, etc.)
- Suffering from serious heart disease .
Show all 10Show fewer
- Hearing-impaired .
- Intracranial hypertension .
- Participating in other clinical trials.
- Participants who received other interventions within 4 weeks prior to enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Mechanism of Repeated Transcranial Magnetic Stimulation in Children With Autism Spectrum Disorder: an Open-label Clinical Trial
This study is a 6-week open-label clinical trial involving 20 children aged 6-10 years with autism spectrum disorder. During the study, subjects received repeated transcranial magnetic stimulation（rTMS）intervention at the left primary motor cortex (M1) 5 times per day for 10 days. From the beginning of intervention to the end of 4 weeks after the completion of intervention, the subjects's clinical symptomatology, cognitive psychology, neuroimaging, and adverse events will be followed up.Our purpose is to explore whether rTMS can improve the clinical symptoms of children with autism spectrum disorder in China, and to explore the neurophysiological mechanism of rTMS for autistic children.
Read the detailed description
Participants will receive continuous theta burst stimulation (cTBS) for a 10-day period (10 sessions). If feasible for the participant, all stimulation sessions will be held at the same time of the day. During this study，participants' clinical symptomatology, cognitive psychology, neuroimaging, and adverse events will be followed up for four times, specifically，before intervention, 5 days after intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention.
- Conditions
- Autism Spectrum Disorder
- Being tested
- repetitive Transcranial Magnetic Stimulation
- Keywords
- Repetitive Transcranial Magnetic Stimulation（rTMS）, Continuous theta Burst Stimulation （cTBS）
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repetitive Transcranial Magnetic StimulationDevice
A technique that involves the use of electrical coils on the head to generate a brief magnetic field which reaches the cerebral cortex.
| Study group | Role | What they receive |
|---|---|---|
| rTMS Group | Experimental | Participants will receive continuous theta burst stimulation (cTBS) for a 10-day period (10 sessions). If feasible for the participant, all stimulation sessions will be held at the same time of the day. Receives: Device: repetitive Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social Response Scale (SRS)
SRS is a questionnaire used to assess the presence and severity of social impairment, with high scores indicating severe symptoms. Change of the SRS from baseline to 3 month after treatment to evaluate the effect of computer social interaction treatment on ASD children.
Measured: Before intervention, 5 days after intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention
Secondary outcomes (5)
Repetitive Stereotyped Behavior - Revised (RBS-R)
The Repetitive Behaviors Scale - Revised (RBS-R) is a 44-item self-report questionnaire that is used to measure the breadth of repetitive behavior in children, adolescents, and adults with Autism Spectrum disorders. The RBS-R provides a quantitative, continuous measure of the full spectrum of repetitive behaviors. The RBS-R consists of six subscales including: Stereotyped Behavior, Self-injurious Behavior, Compulsive Behavior, Routine Behavior, Sameness Behavior, and Restricted Behavior, that have no overlap of item content.
Measured: Before intervention, 5 days after intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention
ADHD Rating Scale
ADHD Rating Scale is the most widely used ADHD screening and treatment monitoring tools.
Measured: Before intervention, 5 days after intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention
Behavior Rating Inventory of Executive Function(BRIEF)
Specifically the investigators will evaluate the changes in executive function (EF) scores before and after cTBS treatment. The higer scores indicate more impairment in executive function.
Measured: Before intervention, 5 days after intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention
Childhood Autism Rating Scale (CARS)
CARS is a behaviour-rating scale used to assess the presence and severity of the symptoms of autism spectrum disorder(ASD), with scores ranging from 15 to 60 and high scores indicating severe symptoms. Change of the CARS from baseline to 3 months after treatment to evaluate the effect of tablet computer social interaction treatment on ASD children.
Measured: Before intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention
Clinical Efficacy Rating Scale (CGI)
CGI is a scale used to assess the severity of the illness and the global improvement of the patient under intervention.
Measured: 5 days after intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start28 Jan 2022
- Primary completion29 Mar 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Mental Health Center
- Responsible party
- Principal investigator, Fei Li, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Fei Li, Director, Principal investigator, Xinhua hospital Affilated to Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05238298
- Sponsor's protocol ID
- XHEC-C-2022-008
- Status last verified
- May 2022
- First submitted
- 29 Jan 2022
- Last updated
- 5 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Mechanism of Repeated Transcranial Magnetic Stimulation in Children With Autism Spectrum Disorder: an Open-label Clinical Trial
- ClinicalTrials.gov ID
- NCT05238298
- Acronym / sponsor ID
- XHEC-C-2022-008
- Conditions
- Autism Spectrum Disorder
- Keywords
- Repetitive Transcranial Magnetic Stimulation（rTMS）, Continuous theta Burst Stimulation （cTBS）
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- Shanghai Mental Health Center
- Study start
- 28 Jan 2022 (actual)
- Primary completion
- 29 Mar 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 14 Feb 2022 (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.
This study is a 6-week open-label clinical trial involving 20 children aged 6-10 years with autism spectrum disorder. During the study, subjects received repeated transcranial magnetic stimulation（rTMS）intervention at the left primary motor cortex (M1) 5 times per day for 10 days. From the beginning of intervention to the end of 4 weeks after the completion of intervention, the subjects's clinical symptomatology, cognitive psychology, neuroimaging, and adverse events will be followed up.Our purpose is to explore whether rTMS can improve the clinical symptoms of children with autism spectrum disorder in China, and to explore the neurophysiological mechanism of rTMS for autistic children.
Detailed description
Participants will receive continuous theta burst stimulation (cTBS) for a 10-day period (10 sessions). If feasible for the participant, all stimulation sessions will be held at the same time of the day. During this study，participants' clinical symptomatology, cognitive psychology, neuroimaging, and adverse events will be followed up for four times, specifically，before intervention, 5 days after intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rTMS Group | Experimental | Device: repetitive Transcranial Magnetic StimulationParticipants will receive continuous theta burst stimulation (cTBS) for a 10-day period (10 sessions). If feasible for the participant, all stimulation sessions will be held at the same time of the day. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged 6-10 years.
- Meeting the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Edition 5 (DSM-5) .
- Confirmed by the ADOS and/or ADI-R diagnostic tool.
- IQ ≥70.
- Informed consent.
Key exclusion criteria (10 listed)
- Patients with metal implants .
- Patients with neurological diseases such as epilepsy .
- Patients requiring surgical treatment due to structural abnormalities indicated by brain MRI .
- Genetic or chromosomal abnormalities .
- Suffering from mental disorders (such as mood disorders, etc.)
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 |
|---|---|---|
| repetitive Transcranial Magnetic StimulationA technique that involves the use of electrical coils on the head to generate a brief magnetic field which reaches the cerebral cortex. | Device | rTMS Group |
Primary outcome
Social Response Scale (SRS)
Time frame: Before intervention, 5 days after intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention
SRS is a questionnaire used to assess the presence and severity of social impairment, with high scores indicating severe symptoms. Change of the SRS from baseline to 3 month after treatment to evaluate the effect of computer social interaction treatment on ASD children.
5 secondary outcomes
Repetitive Stereotyped Behavior - Revised (RBS-R)
Time frame: Before intervention, 5 days after intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention
ADHD Rating Scale
Time frame: Before intervention, 5 days after intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention
Behavior Rating Inventory of Executive Function(BRIEF)
Time frame: Before intervention, 5 days after intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention
Childhood Autism Rating Scale (CARS)
Time frame: Before intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention
Clinical Efficacy Rating Scale (CGI)
Time frame: 5 days after intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
- Individual participant dataSharing planned: No
Related trials for Autism Spectrum Disorder
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
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.
Fei Li, Director principal investigator
Xinhua hospital Affilated to Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing repetitive Transcranial Magnetic Stimulation in people with Autism Spectrum Disorder, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine 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 5 inclusion and 10 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: finished, as of the sponsor's last update on 5 May 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social Response Scale (SRS) (time frame: Before intervention, 5 days after intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention). 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 5 May 2022.