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New treatment option for Autism Spectrum Disorder
Official title pBFS Guided rTMS Over Cognitive Control Network for ASD
ClinicalTrials.gov ID: NCT06255535
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 30
You may be able to join if
- 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
You likely can't join if
- Genetic Disorders, such as (e.g., Down syndrome, Fragile X syndrome, Rett syndorme), Current or history of severe ADHD, tourette syndrome, psychotic...
- 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
See the full eligibility 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Fuzhou, Fujian, China
- Baoding, Hebei, China
- Xi'an, Shaanxi, China
- Jining, Shandong, China
- Linyi, Shandong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 30 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fuzhou, Fujian, China; Baoding, Hebei, China; Xi'an, Shaanxi, China; Jining, Shandong, China; Linyi, Shandong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.