Autism Spectrum DisorderNCT06031948
pBFS-guided Noninvasive Neuromodulation for Pre-school Children With ASD
A study testing active iTBS in people with Autism Spectrum Disorder, run by Changping Laboratory.
Trial summary
This randomized controlled trial aims to evaluate the efficacy and safeness of the pBFS-guided rTMS intervention for core symptom relief in pre-school children with autism spectrum disorder (ASD). Read more about this study
- Who is it for?
- Ages 30 months to 6 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- active iTBS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2023to 1 Jan 2025
- 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 30 months to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 2.5-6 years old
- Have the diagnosis of autism spectrum disorder
- ADOS-2 score is higher than the ASD cut-offs
- Capacity to follow the study procedures, including fMRI scan under sedation, assessment, and rehabilitation training
- Participant's parents or other legal guardians give informed consent
Who cannot join
- Current or history of psychotic disorders, such as schizophrenia, schizoaffective disorder, bipolar disorder
- Severe self-injury or suicidal behavior presented in the last 1 year
- Severe visual, auditory, or motor disability that interferes with any study procedure
- Current, history or family history of epilepsy
- Known severe physical diseases, such as congenital heart defect, traumatic brain injury
- Metal implantations, which are contradicted by MRI or TMS, such as artificial cardiac pacemakers, stents, cochlear implants
- Received TMS, tCS, FUS, or other neuromodulation treatment in the last 3 months
- Currently participating in other clinical trials
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Personalized Brain Functional Sectors (pBFS) Guided Noninvasive Neuromodulation Treatment for Pre-school Children With Autism Spectrum Disorder (ASD): a Single-center, Double-blinded, Sham-Controlled, Randomized Clinical Trial Study
This randomized controlled trial aims to evaluate the efficacy and safeness of the pBFS-guided rTMS intervention for core symptom relief in pre-school children with autism spectrum disorder (ASD).
Read the detailed description
Autism spectrum disorder is a neurodevelopmental disorder, begins early in life. Using the personalized brain functional sectors (pBFS) technology, investigators could precisely identify individualized brain function networks based on the functional MRI scan. For each participant, two personalised TMS intervention targets will be chosen by blinded researcher. One executive function network target is located in the dorsal lateral prefrontal cortex (DLPFC) , and the other social function network target is located in the dorsal medial prefrontal cortex (DMPFC).
The participants will be equally randomized to the following four groups, active iTBS to the left DMPFC or the left DLPFC, and sham iTBS to either the left DMPFC or left DLPFC at a ratio of 2:2:1:1. Later analyses will combine the two sham groups as one control group. Each participant will receive 1800 pulse active or sham iTBS (100% RMT) in each session, 3 sessions daily, 5 days per week for 8 weeks, as well as background behavioral training between iTBS sessions. Pre-and post-treatment functional MRI data will be collected under sedation.
- Conditions
- Autism Spectrum Disorder
- Being tested
- active iTBS, sham iTBS
- Keywords
- TMS, ASD, fMRI, personalized medicine
- 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.
active iTBSDevice
Each participant will receive 1800 pulse active iTBS (100% RMT) in each session, 3 sessions per day, 5 days per week for 8 weeks.
active iTBSDevice
Each participant will receive 1800 pulse active iTBS (100% RMT) in each session, 3 sessions per day, 5 days per week for 8 weeks.
sham iTBSDevice
Each participant will receive 1800 pulse sham iTBS (100% RMT) in each session, 3 sessions per day, 5 days per week for 8 weeks.
sham iTBSDevice
Each participant will receive 1800 pulse sham iTBS (100% RMT) in each session, 3 sessions per day, 5 days per week for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| DLPFC group | Experimental | Active iTBS will be delivered to the left DLPFC. Receives: Device: active iTBS |
| DMPFC group | Experimental | Active iTBS will be delivered to the left DMPFC. Receives: Device: active iTBS |
| Sham to DLPFC group | Sham comparator | Sham iTBS will be delivered to the left DLPFC. Receives: Device: sham iTBS |
| Sham to DMPFC group | Sham comparator | Sham iTBS will be delivered to the left DMPFC. Receives: Device: sham iTBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADOS-2 SA change
The social affect (SA) dimension score change of autism diagnostic observation scale, 2nd edition (ADOS-2) from baseline. Higher scores mean a worse outcome.
Measured: Pre-treatment (baseline), immediately post-treatment
Secondary outcomes (2)
ADOS-2 total score change
The total score change of autism diagnostic observation scale, 2nd edition (ADOS-2) from baseline. Higher scores mean a worse outcome.
Measured: Pre-treatment (baseline), immediately post-treatment
CBCL score change
Score change of the child behavior checklist (CBCL) from baseline. Higher scores mean a worse outcome.
Measured: Pre-treatment (baseline), immediately post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start1 Oct 2023 (estimated)
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changping Laboratory
- Sponsor type
- University, hospital or other
- Collaborators
- Henan Provincial People's Hospital
- Responsible party
- Sponsor
- Investigators
- Hesheng Liu, Ph.D., Study chair, Changping Laboratory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06031948
- Sponsor's protocol ID
- CPLASD2023HNC50
- Status last verified
- Sep 2023
- First submitted
- 4 Sep 2023
- Last updated
- 11 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Brain Functional Sectors (pBFS) Guided Noninvasive Neuromodulation Treatment for Pre-school Children With Autism Spectrum Disorder (ASD): a Single-center, Double-blinded, Sham-Controlled, Randomized Clinical Trial Study
- ClinicalTrials.gov ID
- NCT06031948
- Acronym / sponsor ID
- CPLASD2023HNC50
- Conditions
- Autism Spectrum Disorder
- Keywords
- TMS, ASD, fMRI, personalized medicine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Changping LaboratoryUniversity, hospital or other
- Collaborators
- Henan Provincial People's Hospital
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 11 Sep 2023 (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 randomized controlled trial aims to evaluate the efficacy and safeness of the pBFS-guided rTMS intervention for core symptom relief in pre-school children with autism spectrum disorder (ASD).
Detailed description
Autism spectrum disorder is a neurodevelopmental disorder, begins early in life. Using the personalized brain functional sectors (pBFS) technology, investigators could precisely identify individualized brain function networks based on the functional MRI scan. For each participant, two personalised TMS intervention targets will be chosen by blinded researcher. One executive function network target is located in the dorsal lateral prefrontal cortex (DLPFC) , and the other social function network target is located in the dorsal medial prefrontal cortex (DMPFC).
The participants will be equally randomized to the following four groups, active iTBS to the left DMPFC or the left DLPFC, and sham iTBS to either the left DMPFC or left DLPFC at a ratio of 2:2:1:1. Later analyses will combine the two sham groups as one control group. Each participant will receive 1800 pulse active or sham iTBS (100% RMT) in each session, 3 sessions daily, 5 days per week for 8 weeks, as well as background behavioral training between iTBS sessions. Pre-and post-treatment functional MRI data will be collected under sedation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| DLPFC group | Experimental | Device: active iTBSActive iTBS will be delivered to the left DLPFC. |
| DMPFC group | Experimental | Device: active iTBSActive iTBS will be delivered to the left DMPFC. |
| Sham to DLPFC group | Sham comparator | Device: sham iTBSSham iTBS will be delivered to the left DLPFC. |
| Sham to DMPFC group | Sham comparator | Device: sham iTBSSham iTBS will be delivered to the left DMPFC. |
Who may qualify
- Ages
- 30 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 2.5-6 years old
- Have the diagnosis of autism spectrum disorder
- ADOS-2 score is higher than the ASD cut-offs
- Capacity to follow the study procedures, including fMRI scan under sedation, assessment, and rehabilitation training
- Participant's parents or other legal guardians give informed consent
Key exclusion criteria (8 listed)
- Current or history of psychotic disorders, such as schizophrenia, schizoaffective disorder, bipolar disorder
- Severe self-injury or suicidal behavior presented in the last 1 year
- Severe visual, auditory, or motor disability that interferes with any study procedure
- Current, history or family history of epilepsy
- Known severe physical diseases, such as congenital heart defect, traumatic brain injury
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 |
|---|---|---|
| active iTBSEach participant will receive 1800 pulse active iTBS (100% RMT) in each session, 3 sessions per day, 5 days per week for 8 weeks. | Device | DLPFC group |
| active iTBSEach participant will receive 1800 pulse active iTBS (100% RMT) in each session, 3 sessions per day, 5 days per week for 8 weeks. | Device | DMPFC group |
| sham iTBSEach participant will receive 1800 pulse sham iTBS (100% RMT) in each session, 3 sessions per day, 5 days per week for 8 weeks. | Device | Sham to DLPFC group |
| sham iTBSEach participant will receive 1800 pulse sham iTBS (100% RMT) in each session, 3 sessions per day, 5 days per week for 8 weeks. | Device | Sham to DMPFC group |
Primary outcome
ADOS-2 SA change
Time frame: Pre-treatment (baseline), immediately post-treatment
The social affect (SA) dimension score change of autism diagnostic observation scale, 2nd edition (ADOS-2) from baseline. Higher scores mean a worse outcome.
2 secondary outcomes
ADOS-2 total score change
Time frame: Pre-treatment (baseline), immediately post-treatment
CBCL score change
Time frame: Pre-treatment (baseline), immediately post-treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
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.
Hesheng Liu, Ph.D. study chair
Changping Laboratory
Questions about this trial
What is this clinical trial studying?
A study testing active iTBS in people with Autism Spectrum Disorder, run by Changping Laboratory.
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 8 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 11 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Qi Liu, Ph.D. (010-80726688, a0000153@cpl.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ADOS-2 SA change (time frame: Pre-treatment (baseline), immediately post-treatment). 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 11 Sep 2023.