Clinical trial NCT05890846: Precision TMS Treatment Guided by Personalized Brain Functional Sectors (pBFS) for ASD
Official title: Personalized Brain Functional Sectors (pBFS) Guided Transcranial Magnetic Stimulation (TMS) Treatment for Autism Spectrum Disorder (ASD): a Sham-controlled, Double-blinded, Randomized Clinical Trial Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: TMS
personalized medicine
ASD
fMRI
Lead sponsor: Changping Laboratory
Sponsor class: OTHER
Collaborators: name: Henan Provincial People's Hospital
name: China Rehabilitation Research Center
First posted: 2023-06-06
Enrollment: 66
Sex: ALL
Minimum age (years): 6
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy and safety of pBFS-guided TMS treatment for the core symptom in autism spectrum disorder children, adolescents and young adults.

Detailed description: Autism spectrum disorder is a neurodevelopmental disorder characterized by impaired social communication and repetitive behaviors. Broad cognitive control function deficit in ASD suggested cognitive control function as a potential phenotype and treatment target. Using the personalized Brain Functional Sectors (pBFS) technique, investigators could precisely identify individualized brain areas underlying cognitive control function based on the task free functional MRI data. The tailored TMS intervention target to cognitive control function network which located in the left dorsal lateral prefrontal cortex (DLPFC) will be selected for each participant by a blinded researcher.

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.

Eligibility criteria: Inclusion Criteria:

* Nearest age 6-30 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 parent or other legal guardian give informed consent

Exclusion Criteria:

* Current or history of psychotic disorders, such as schizophrenia, schizoaffective disorder, bipolar disorder
* 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

Primary outcomes:
measure: Response rate after 12 weeks treatment
timeFrame: Pre-treatment (baseline), after 12-weeks treatment
Secondary outcomes:
measure: Response rate after 8 weeks treatment
timeFrame: Pre-treatment (baseline), after 8-weeks treatment
measure: ADOS-2 SA score change
timeFrame: Pre-treatment (baseline), after 8-weeks treatment，after 12-weeks tretment
measure: SCQ score change
timeFrame: Pre-treatment (baseline), after 8-weeks treatment，after 12-weeks tretment
measure: ADOS-2 total score change
timeFrame: Pre-treatment (baseline), after 8-weeks treatment，after 12-weeks tretment
measure: CBCL score change
timeFrame: Pre-treatment (baseline), after 8-weeks treatment，after 12-weeks tretment
measure: SRS-2 score change
timeFrame: Pre-treatment (baseline), after 8-weeks treatment，after 12-weeks tretment
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Beijing
country: China
facility: China Rehabilitation Research Center
Study officials:
affiliation: Changping Laboratory
name: Hesheng Liu, Ph.D.
role: STUDY_CHAIR
References: