Autism Spectrum Disorder
Conditions
Keywords
TMS, personalized medicine, ASD, fMRI
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.
Interventions
DEVICEactive 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.
DEVICEsham 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.
BEHAVIORALtraditional 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.
Sponsors
Henan Provincial People's Hospital
China Rehabilitation Research Center
Changping Laboratory
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 30 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response rate after 12 weeks treatment | Pre-treatment (baseline), after 12-weeks treatment | Treatment response is defined as improvement, i.e., scores decreased, in both the social affect (SA) dimension score change of autism diagnostic observation scale, 2nd edition (ADOS-2) from baseline. For ADOS-2 SA, higher scores means more severe symptom. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ADOS-2 SA score change | Pre-treatment (baseline), after 8-weeks treatment，after 12-weeks tretment | The ADOS-2 SA score changes from baseline. Higher scores mean a worse outcome. |
| SCQ score change | Pre-treatment (baseline), after 8-weeks treatment，after 12-weeks tretment | SCQ score change from baseline. Higher scores mean a worse outcome. |
| Response rate after 8 weeks treatment | Pre-treatment (baseline), after 8-weeks treatment | Treatment response is defined as improvement, i.e., scores decreased, in the social affect (SA) dimension score change of autism diagnostic observation scale, 2nd edition (ADOS-2) from baseline. For ADOS-2 SA, higher scores means more severe symptom. |
| CBCL score change | Pre-treatment (baseline), after 8-weeks treatment，after 12-weeks tretment | Score change of the child behavior checklist (CBCL) from baseline. Higher scores mean a worse outcome. |
| SRS-2 score change | Pre-treatment (baseline), after 8-weeks treatment，after 12-weeks tretment | Score change of the Social Responsiveness Scale, 2nd edition (SRS-2) from baseline. Higher scores mean a worse outcome. |
| ADOS-2 total score change | Pre-treatment (baseline), after 8-weeks treatment，after 12-weeks tretment | The ADOS-2 total score change from baseline. Higher scores mean a worse outcome. |
Countries
China
Contacts
Primary ContactQi Liu, Ph.D.
Outcome results
None listed