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New treatment option for Autism Spectrum Disorder
Official title pBFS Guided aiTBS Over Language Network for ASD Child
ClinicalTrials.gov ID: NCT06950437
What this study is testing
- What it's testing
- The aim of this trial is to evaluate the efficacy and safety of precision neuromodulation in improving language ability in children with autism spectrum disorder (ASD) who also have language development delay. The neuromodulation will be delivered using the accelerated intermittent theta burst stimulation (aiTBS) protocol, targeting the language network in the left superior frontal gyrus (SFG), 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 3 to 6
You may be able to join if
- Professionally diagnosed with ASD per DSM - 5 criteria.
- Aged 3 - 6.5 years, either gender.
- ADOS-2 results meet ASD standard cut - off.
- SCQ score: ≥15 (age ≥ 4 years) or ≥11 (age \< 4 years).
- Co-existing language disorder not explaining ASD symptoms. No organic speech organ lesions. CNBS-R2016 and CLAS-TP language-related equivalent age \>...
You likely can't join if
- Identified genetic pathogenic factors; current/past comorbid severe disorders (ADHD, Tourette's, etc.).
- Serious self-harm in the past year.
- Severe sensory/motor disorders precluding cooperation.
- History of epileptic seizures.
- Serious organic diseases, especially brain related.
- Contraindications for MRI/TMS (metal/implants).
See the full eligibility criteria
- Professionally diagnosed with ASD per DSM - 5 criteria.
- Aged 3 - 6.5 years, either gender.
- ADOS-2 results meet ASD standard cut - off.
- SCQ score: ≥15 (age ≥ 4 years) or ≥11 (age \< 4 years).
- Co-existing language disorder not explaining ASD symptoms. No organic speech organ lesions. CNBS-R2016 and CLAS-TP language-related equivalent age \> 18 months; any CLAS-TP dimension score \< 6.
- Mandarin is the daily communication language.
- May have intellectual/global developmental delay not explaining ASD symptoms.
- Guardians volunteer, can cooperate in treatment and sign informed consent.
- Identified genetic pathogenic factors; current/past comorbid severe disorders (ADHD, Tourette's, etc.).
- Serious self-harm in the past year.
- Severe sensory/motor disorders precluding cooperation.
- History of epileptic seizures.
- Serious organic diseases, especially brain related.
- Contraindications for MRI/TMS (metal/implants).
- Respiratory/circulatory diseases with sedation risk.
- Illiterate guardians unable to handle informed consent/questionnaires.
- Received neuromodulation in the past 3 months.
- Currently in other clinical trials.
- Deemed unfit by the researcher.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, 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, 3 years to 6 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, 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.