pBFS-guided Noninvasive Neuromodulation for Pre-school Children With ASD
NCT ID: NCT06031948
Last Updated: 2023-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2023-10-01
2025-01-01
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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DLPFC group
Active iTBS will be delivered to the left DLPFC.
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.
DMPFC group
Active iTBS will be delivered to the left DMPFC.
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 to DLPFC group
Sham iTBS will be delivered to the left DLPFC.
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 to DMPFC group
Sham iTBS will be delivered to the left DMPFC.
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.
Interventions
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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.
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 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 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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
30 Months
6 Years
ALL
No
Sponsors
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Henan Provincial People's Hospital
OTHER
Changping Laboratory
OTHER
Responsible Party
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Principal Investigators
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Hesheng Liu, Ph.D.
Role: STUDY_CHAIR
Changping Laboratory
Central Contacts
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Other Identifiers
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CPLASD2023HNC50
Identifier Type: -
Identifier Source: org_study_id
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