Autism Spectrum DisorderNCT05472870
Efficacy and Mechanism of rTMS in Children With ASD: an Open-label Clinical Trial(Ⅱ)
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 open-label clinical trial involving over 30 ASD children aged ≥4 years old. During the study, subjects received repeated transcranial magnetic stimulation (rTMS) intervention on the left primary motor cortex (M1) 10 times per day for 5 consecutive days and complete clinical assessments from… Read more about this study
- Who is it for?
- Ages 4 to 16 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
- 30 participants
- Where
- 1 siteChina
- Study dates
- 12 Jul 2022to 20 Jan 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 4 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged ≥4 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.
- 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 .
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- 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(Ⅱ)
This study is a open-label clinical trial involving over 30 ASD children aged ≥4 years old. During the study, subjects received repeated transcranial magnetic stimulation (rTMS) intervention on the left primary motor cortex (M1) 10 times per day for 5 consecutive days and complete clinical assessments from pre-intervention to post-intervention. This study hopes to explore whether accelerated continuous theta-burst stimulation (a-cTBS) over left primary motor cortex (M1) can improve clinical symptoms of children with ASD in China.
Read the detailed description
This study is a single-arm open-label clinical trial, designed to enroll at least 30 children with ASD aged over 4 years old.
During the trial, participants will receive accelerated continuous theta-burst stimulation (a-cTBS)on the left primary motor cortex (M1) for 5 consecutive days and complete clinical assessments within 2 weeks before the cTBS intervention (pre-cTBS), repeated within 3 days after the completion of the cTBS course (post-cTBS) and 1 month following the last cTBS session (one month follow-up), respectively. The purpose of this current study is to explore whether rTMS can improve the clinical symptoms of children with autism spectrum disorder in China, and to investigate the neurophysiological mechanism of rTMS for ASD children.
- 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 cTBS over the left primary motor cortext (M1) for 5 consecutive days. The detailed parameters as follows: 80% of RMT, 60 cycles of 10 bursts of three pulses at 50 Hz were delivered in 2-second trains (5 Hz) with no intertrain interval (i.e. triplet standard cTBS, 1800 pulses, 120s). Stimulation sessions were delivered hourly, 10 sessions were applied per day (18,000 pulses/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) Scores
Social Response Scale (SRS) is a parent questionnaire used to assess the presence and severity of social impairment. The SRS generates a total score and five subscale scores (social awareness, social cognition, social communication, social motivation, and autistic mannerisms), and 5 subscales scores are summed to compute the total score; higher scores indicate greater social impairment.
The SRS total score range is "0-195", the social awareness subscale score range is "0-24", the social cognition subscale score range is "0-36", the social communication subscale score range is "0-66", the social motivation subscale score range is "0-33", and the autistic mannerisms subscale score range is "0-36".
We collected the SRS from baseline to 1 month follow-up to evaluate the effect of rTMS treatment on ASD syptoms among these children.
Measured: Baseline, immediately after the completion of 5-days intervention, and 4 weeks after the completion of intervention.
Secondary outcomes (7)
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 1 months after treatment to evaluate the effect of rTMS treatment on ASD.
children.
Measured: Baseline, and 4 weeks after the completion of intervention.
Behavior Rating Inventory of Executive Function (BRIEF)
BRIEF is a quick and efficient measure of executive function(have school-age version (BRIEF-S) and preschool version (BRIEF-P)), we asked parents to complete the 86-item (BRIEF-S) or 63-item (BRIEF-P) form to rate a child's executive functions (1-3 score) within the context of his everyday environments (home or school).
Here we report the BRIEF composite score, BRIEF-S score range is 86 -258 and BRIEF-P score range is 63-189. The higer scores indicate more impairment in executive function.
We evaluate the changes in executive function (EF) scores before and after cTBS treatment.
Measured: Baseline, immediately after the completion of 5-days intervention, and 4 weeks after the completion of intervention.
Conners Parent Symptom Questionnaire (PSQ)
Conners Parent Symptom Questionnaire (PSQ) is a questionnaire screening for children's behavioral problems (especially with ADHD), it has 48 items（4-stage: 0-3) that can be divided into 6 factors (conduct problems, learning problems, psychosomatic problems, impulsive-hyperactivity, anxiety, and hyperactivity index). Add the scores and divide by the item numbers of each factor to get Z score.
Here we mainly observe the changes in Hyperactivity Index (HI) Z scores, it ranges from 0-3, a higher score mean a worse outcome.
Measured: Baseline, immediately after the completion of 5-days intervention, and 4 weeks after the completion of intervention.
Peabody Picture Vocabulary Test（PPVT）
The Peabody Picture Vocabulary Test is one of the most commonly used assessment tests for measuring single-word comprehension. The raw score ranges from 0-110, the higher scores mean a better outcome. we collected the PPVT raw score from baseline to 1 months after treatment to evaluate the effect of rTMS treatment on ASD children's words comprehension.
Measured: Baseline, and 4 weeks after the completion of intervention.
Chinese Communicative Development Inventory (CCDI)
CCDI provides a powerful tool to assess early vocabulary development and the language skills of older children with developmental disorders and the effectiveness of their intervention. Here we collected the CCDI words produced score, it ranges from 0-798. The higher scores mean a better outcome.
Measured: Baseline and 4 weeks after the completion of intervention.
Clinical Global Impression of Improvement (CGI-I)
CGI is a scale used to assess the severity of the illness and the global improvement of the patient under intervention. Here we used Clinical Global Impression of Improvement (CGI-I) to rate how much the patient's illness has improved or worsened relative to baseline (a seven-point scale: 1 = "very much improved" to 7 = "very much worse"). The CGI was carried out by trained clinical assessors according to children's CARS、ADOS assessment results and parent interviews before and after intervention. We calculated the number of subjects with improvement (CGI-I≤3).
Measured: After the completion of 5-days intervention and 4 weeks after the completion of intervention.
Repetitive Behaviors Scale - Revised (RBS-R)
The Repetitive Behaviors Scale - Revised (RBS-R) is a 44-item (rated 0-3) 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.
Here we use the RBS-R total score, it ranges from 0-132, the higher score means worse repetitive behavior.
Measured: baseline, immediately after the completion of 5-days 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 posted25 Jul 2022
- Study start12 Jul 2022
- Primary completion15 Dec 2022
- Study completion20 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 30 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, Principal investigator, Xinhua hospital Affilated to Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05472870
- Sponsor's protocol ID
- XHEC-C-2022-008-4
- Status last verified
- Aug 2024
- First submitted
- 22 Jul 2022
- Last updated
- 21 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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 21 Aug 2024. 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(Ⅱ)
- ClinicalTrials.gov ID
- NCT05472870
- Acronym / sponsor ID
- XHEC-C-2022-008-4
- Conditions
- Autism Spectrum Disorder
- Keywords
- Repetitive Transcranial Magnetic Stimulation（rTMS）, Continuous theta Burst Stimulation （cTBS）
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- Shanghai Mental Health Center
- Study start
- 12 Jul 2022 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 20 Jan 2023 (actual)
- First posted
- 25 Jul 2022 (actual)
- Results
- Posted 21 Aug 2024
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 open-label clinical trial involving over 30 ASD children aged ≥4 years old. During the study, subjects received repeated transcranial magnetic stimulation (rTMS) intervention on the left primary motor cortex (M1) 10 times per day for 5 consecutive days and complete clinical assessments from pre-intervention to post-intervention. This study hopes to explore whether accelerated continuous theta-burst stimulation (a-cTBS) over left primary motor cortex (M1) can improve clinical symptoms of children with ASD in China.
Detailed description
This study is a single-arm open-label clinical trial, designed to enroll at least 30 children with ASD aged over 4 years old.
During the trial, participants will receive accelerated continuous theta-burst stimulation (a-cTBS)on the left primary motor cortex (M1) for 5 consecutive days and complete clinical assessments within 2 weeks before the cTBS intervention (pre-cTBS), repeated within 3 days after the completion of the cTBS course (post-cTBS) and 1 month following the last cTBS session (one month follow-up), respectively. The purpose of this current study is to explore whether rTMS can improve the clinical symptoms of children with autism spectrum disorder in China, and to investigate the neurophysiological mechanism of rTMS for ASD children.
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 cTBS over the left primary motor cortext (M1) for 5 consecutive days. The detailed parameters as follows: 80% of RMT, 60 cycles of 10 bursts of three pulses at 50 Hz were delivered in 2-second trains (5 Hz) with no intertrain interval (i.e. triplet standard cTBS, 1800 pulses, 120s). Stimulation sessions were delivered hourly, 10 sessions were applied per day (18,000 pulses/day). |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged ≥4 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.
- 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) Scores
Time frame: Baseline, immediately after the completion of 5-days intervention, and 4 weeks after the completion of intervention.
Social Response Scale (SRS) is a parent questionnaire used to assess the presence and severity of social impairment. The SRS generates a total score and five subscale scores (social awareness, social cognition, social communication, social motivation, and autistic mannerisms), and 5 subscales scores are summed to compute the total score; higher scores indicate greater social impairment. The SRS total score range is "0-195", the social awareness subscale score range is "0-24", the social cognition subscale score range is "0-36", the social communication subscale score range is "0-66", the social motivation subscale score range is "0-33", and the autistic mannerisms subscale score range is "0-36". We collected the SRS from baseline to 1 month follow-up to evaluate the effect of rTMS treatment on ASD syptoms among these children.
7 secondary outcomes
Childhood Autism Rating Scale (CARS)
Time frame: Baseline, and 4 weeks after the completion of intervention.
Behavior Rating Inventory of Executive Function (BRIEF)
Time frame: Baseline, immediately after the completion of 5-days intervention, and 4 weeks after the completion of intervention.
Conners Parent Symptom Questionnaire (PSQ)
Time frame: Baseline, immediately after the completion of 5-days intervention, and 4 weeks after the completion of intervention.
Peabody Picture Vocabulary Test（PPVT）
Time frame: Baseline, and 4 weeks after the completion of intervention.
Chinese Communicative Development Inventory (CCDI)
Time frame: Baseline and 4 weeks after the completion of intervention.
Clinical Global Impression of Improvement (CGI-I)
Time frame: After the completion of 5-days intervention and 4 weeks after the completion of intervention.
Repetitive Behaviors Scale - Revised (RBS-R)
Time frame: baseline, immediately after the completion of 5-days intervention, and 4 weeks after the completion of intervention.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Fei Li 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 4 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 21 Aug 2024. 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?
Yes. Results are posted in the registry (first posted 21 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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) Scores (time frame: Baseline, immediately after the completion of 5-days 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 21 Aug 2024.