Precision TMS Treatment Guided by Personalized Brain Functional Sectors (pBFS) for ASD
NCT ID: NCT05890846
Last Updated: 2024-04-02
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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RECRUITING
NA
66 participants
INTERVENTIONAL
2022-06-25
2025-09-20
Brief Summary
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Detailed Description
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The participants will be equally randomized to the active iTBS to the cognitive control function network, and sham iTBS at a ratio of 2:1. Each participant will receive 5 days of treatment per week for 12 weeks. Functional MRI data under sedation will be collected pre-and post-treatment. Three behavioral evaluations will be taken pre-treatment, after 8-weeks treatment and after 12-weeks treatment.
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 cognitive control network at 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 12 weeks.
traditional 1on1 course
Between every two iTBS sessions, the participant will receive a personalized 30-minutes one-on-one behavioral course, 2 courses per day, 5 days per week for 12 weeks.
Sham group
Sham iTBS will be delivered to the cognitive control network at 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 12 weeks.
traditional 1on1 course
Between every two iTBS sessions, the participant will receive a personalized 30-minutes one-on-one behavioral course, 2 courses per day, 5 days per week for 12 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 12 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 12 weeks.
traditional 1on1 course
Between every two iTBS sessions, the participant will receive a personalized 30-minutes one-on-one behavioral course, 2 courses per day, 5 days per week for 12 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 parent or other legal guardian give informed consent
Exclusion Criteria
* Severe self-injury or suicidal behavior presented in the last one year
* Severe visual, auditory, or motor disability that interferes with any study procedure
* Current or history of seizure
* 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
6 Years
30 Years
ALL
No
Sponsors
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Henan Provincial People's Hospital
OTHER
China Rehabilitation Research Center
OTHER_GOV
Changping Laboratory
OTHER
Responsible Party
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Principal Investigators
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Hesheng Liu, Ph.D.
Role: STUDY_CHAIR
Changping Laboratory
Locations
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Henan Provincial People's Hospital
Zhengzhou, Henan, China
China Rehabilitation Research Center
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Meiyun Wang, M.D.,Ph.D.
Role: primary
Hao Zhang, M.D.,Ph.D.
Role: primary
Other Identifiers
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CPASD2023DL
Identifier Type: -
Identifier Source: org_study_id
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