Autism Spectrum Disorder With Language Delay
Conditions
Keywords
TMS, personalized medicine, ASD, LD
Brief summary
This study will evaluate the feasibility and preliminary efficacy of pBFS-guided TMS treatment at DMPFC in autism spectrum disorder comorbid with language delay.
Detailed description
Autism spectrum disorder is a neurodevelopmental disorder characterized by impaired social communication and repetitive behaviors, often co-occurring with language delay. Using the personalized Brain Functional Sectors (pBFS) technique, investigators could precisely identify individualized brain areas underlying language and social communication a based on the resting-state functional MRI data. The tailored TMS intervention target to language and default mode network which located in the left dorsal medial prefrontal cortex (DMPFC) will be selected for each participant. The participants will receive active iTBS to the language network 5 days per week for 12 weeks. Functional MRI data will be collected pre-and post-treatment under sedation. 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 8 weeks.
Sponsors
Changping Laboratory
China Rehabilitation Research Center
Henan Provincial People's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 30 Years
Healthy volunteers
No
Inclusion criteria
* 6-30 years old * Have the diagnosis of autism spectrum disorder * ADOS-2 score is higher than the ASD cut-offs * Have language development delay (the WISC-4 Verbal Comprehension Index lower than 70) * 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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Language score change | Pre-treatment (baseline), after 8 weeks treatment, immediately post-treatment | The score change of vocabulary acquisition scales (VAS) from the Wechsler Preschool and Primary Scale of Intelligence, Fourth Edition (WPPSI-IV) from baseline. Higher scores mean a better outcome. |
| ADOS-2 SA score change | Pre-treatment (baseline), after 8 weeks treatment, immediately post-treatment | The social affect dimension score change of autism diagnostic observation scale, 2nd edition (ADOS-2) from baseline. Higher scores mean a worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Receptive vocabulary score change | Pre-treatment (baseline), after 8 weeks treatment, immediately post-treatment | The score change of receptive vocabulary (pointing) from the Wechsler Preschool and Primary Scale of Intelligence, Fourth Edition (WPPSI-IV) from baseline. Higher scores mean a better outcome. |
| Expressive language score change | Pre-treatment (baseline), after 8 weeks treatment, immediately post-treatment | The score change of picture naming (naming) from the Wechsler Preschool and Primary Scale of Intelligence, Fourth Edition (WPPSI-IV) from baseline. Higher scores mean a better outcome. |
| SCQ S score change | Pre-treatment (baseline), after 8 weeks treatment, immediately post-treatment | The social dimension score change of the Social Communication Questionnaire (SCQ) from baseline. Higher scores mean a worse outcome. |
| SCQ C score change | Pre-treatment (baseline), after 8 weeks treatment, immediately post-treatment | The communication dimension score change of the Social Communication Questionnaire (SCQ) from baseline. Higher scores mean a worse outcome. |
Countries
China
Outcome results
None listed