NCT06255535 pBFS Guided rTMS Over Cognitive Control Network for ASD
| NCT ID | NCT06255535 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Changping Laboratory |
| Condition | Autism Spectrum Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 215 participants |
| Start Date | 2024-04-01 |
| Primary Completion | 2026-04-01 |
Trial Parameters
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Brief Summary
The aim of this trial is to assess the efficacy and safety of precision neuromodulation for alleviating core symptoms in patients with autism spectrum disorder (ASD) who also have intellectual or developmental delay. The neuromodulation will be administered using intermittent theta burst stimulation (iTBS) targeting the left dorsolateral prefrontal cortex (DLPFC), guided by personalized Brain Functional Sector (pBFS) technology.
Eligibility Criteria
Inclusion Criteria: * 6-30 years old * Have the diagnosis of autism spectrum disorder * ADOS-2 score is higher than the ASD cut-offs * Comorbid with intelligent disorder, IQ/DQ \< 70 * Primary environmental language is Chinese * Participant's parents or other legal guardians give informed consent Exclusion Criteria: * Genetic Disorders, such as (e.g., Down syndrome, Fragile X syndrome, Rett syndorme), Current or history of severe ADHD, tourette syndrome, psychotic disorders (e.g., schizophrenia, schizoaffective disorder, bipolar disorder) * Severe self-injury or suicidal behavior exhibited within the past year * Significant visual, auditory, deafness or motor disability that prevent them from following study procedures * Current or history diagnosis of epilepsy * Known severe physical diseases, particularly those affecting the brain * Metal implantation contradicted by MRI or TMS, such as artificial cardiac pacemakers, stents, cochlear implants * Respiratory or circulatory conditions i