pBFS-guided Noninvasive Neuromodulation for Pre-school Children With ASD
Study Details
Study Description
Brief 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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: DLPFC group Active iTBS will be delivered to the left DLPFC. |
Device: active iTBS
Each participant will receive 1800 pulse active iTBS (100% RMT) in each session, 3 sessions per day, 5 days per week for 8 weeks.
|
| Experimental: DMPFC group Active iTBS will be delivered to the left DMPFC. |
Device: active iTBS
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 Comparator: Sham to DLPFC group Sham iTBS will be delivered to the left DLPFC. |
Device: sham iTBS
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 Comparator: Sham to DMPFC group Sham iTBS will be delivered to the left DMPFC. |
Device: sham iTBS
Each participant will receive 1800 pulse sham iTBS (100% RMT) in each session, 3 sessions per day, 5 days per week for 8 weeks.
|
Outcome Measures
Primary Outcome Measures
- ADOS-2 SA change [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.
Secondary Outcome Measures
- ADOS-2 total score change [Pre-treatment (baseline), immediately post-treatment]
The total score change of autism diagnostic observation scale, 2nd edition (ADOS-2) from baseline. Higher scores mean a worse outcome.
- CBCL score change [Pre-treatment (baseline), immediately post-treatment]
Score change of the child behavior checklist (CBCL) from baseline. Higher scores mean a worse outcome.
Other Outcome Measures
- SCQ score change [Pre-treatment (baseline), immediately post-treatment]
Score change of the Social Communication Questionnaire (SCQ) from baseline. Higher scores mean a worse outcome.
- SRS-2 score change [Pre-treatment (baseline), immediately post-treatment]
Score change of the Social Responsiveness Scale, 2nd edition (SRS-2) from baseline. Higher scores mean a worse outcome.
- RBS-R score change [Pre-treatment (baseline), immediately post-treatment]
Score change of the Repetitive Behavior Scale-Revised (RBS-R) from baseline. Higher scores mean a worse outcome.
Eligibility Criteria
Criteria
Inclusion Criteria:
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2.5-6 years old
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Have the diagnosis of autism spectrum disorder
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ADOS-2 score is higher than the ASD cut-offs
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Capacity to follow the study procedures, including fMRI scan under sedation, assessment, and rehabilitation training
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Participant's parents or other legal guardians give informed consent
Exclusion Criteria:
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Current or history of psychotic disorders, such as schizophrenia, schizoaffective disorder, bipolar disorder
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Severe self-injury or suicidal behavior presented in the last 1 year
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Severe visual, auditory, or motor disability that interferes with any study procedure
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Current, history or family history of epilepsy
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Known severe physical diseases, such as congenital heart defect, traumatic brain injury
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Metal implantations, which are contradicted by MRI or TMS, such as artificial cardiac pacemakers, stents, cochlear implants
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Received TMS, tCS, FUS, or other neuromodulation treatment in the last 3 months
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Currently participating in other clinical trials
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Changping Laboratory
- Henan Provincial People's Hospital
Investigators
- Study Chair: Hesheng Liu, Ph.D., Changping Laboratory
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CPLASD2023HNC50