Status:
UNKNOWN
pBFS-guided Noninvasive Neuromodulation for Pre-school Children With ASD
Lead Sponsor:
Changping Laboratory
Collaborating Sponsors:
Henan Provincial People's Hospital
Conditions:
Autism Spectrum Disorder
Eligibility:
All Genders
30-6 years
Phase:
NA
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).
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 individualize...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06031948
Start Date
October 1 2023
End Date
January 1 2025
Last Update
September 11 2023
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