Autism Spectrum Disorder Clinical Trial
Official title:
Repetitive Transcranial Magnetic Stimulation Guided by Personalized Brain Functional Sectors (pBFS) for Low-Functioning Autism Spectrum Disorder: a Multi-center, Randomized, Sham-controlled Trial
Verified date | April 2024 |
Source | Changping Laboratory |
Contact | Qi Liu, Ph.D. |
Phone | 010-80726688 |
liuqi[@]cpl.ac.cn | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Not yet recruiting |
Enrollment | 150 |
Est. completion date | September 1, 2026 |
Est. primary completion date | April 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 30 Years |
Eligibility | 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 increasing sedation risk, such as Apnea syndrome, severe snoring, or other relevant diseases - All legal guardians are illiterate, unable to read informed documents or complete questionnaires independently - Received transcranial magnetic stimulation (TMS), transcranial current stimulation (tCS), focused ultrasound (FUS), or other neuromodulation treatment in the last 3 months - Current participation in other clinical trials |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Changping Laboratory | Fujian Children's Hospital, Fujian Maternity and Child Health Hospital, Jining Medical University, Linyi Hedong Rehabilitation Hospital, Xi'an TCM Hospital of Encephalopathy |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Response rate after 12 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). For ADOS-2 SA, higher scores means more severe symptom. | Pre-treatment (baseline), immediately post-treatment | |
Secondary | ADOS-2 SA score change | The score changes of ADOS-2 SA from baseline. Higher scores mean a worse outcome. | Pre-treatment (baseline), immediately post-treatment | |
Secondary | SCQ score change | SCQ score change from baseline. Higher scores mean a worse outcome. | Pre-treatment (baseline), immediately post-treatment | |
Secondary | ADOS-2 total score change | The ADOS-2 total score change from baseline. Higher scores mean a worse outcome. | Pre-treatment (baseline), immediately post-treatment | |
Secondary | CBCL score change | Score change of the child behavior checklist (CBCL) from baseline. Higher scores mean a worse outcome. | Pre-treatment (baseline), immediately post-treatment |
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