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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 215 participants in total. It began in 2024-04-01 with a primary completion date of 2026-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
Contact & Investigator
Hesheng Liu, Ph.D.
STUDY CHAIR
Changping Laboratory
Frequently Asked Questions
Who can join the NCT06255535 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 30 Years, studying Autism Spectrum Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06255535 currently recruiting?
Yes, NCT06255535 is actively recruiting participants. Contact the research team at liuqi@cpl.ac.cn for enrollment information.
Where is the NCT06255535 trial being conducted?
This trial is being conducted at Fuzhou, China, Fuzhou, China, Baoding, China, Xi'an, China and 2 additional locations.
Who is sponsoring the NCT06255535 clinical trial?
NCT06255535 is sponsored by Changping Laboratory. The principal investigator is Hesheng Liu, Ph.D. at Changping Laboratory. The trial plans to enroll 215 participants.