NCT06255535Recruiting
pBFS Guided rTMS Over Cognitive Control Network for ASD
Repetitive Transcranial Magnetic Stimulation Guided by Personalized Brain Functional Sectors (pBFS) for Low-Functioning Autism Spectrum Disorder: a Multi-center, Randomized, Sham-controlled Trial
Source: ClinicalTrials.gov · Last updated 21 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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 (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 215 (estimated)
- First submitted
- 5 Feb 2024
- Start date
- 1 Apr 2024
- Primary completion date
- 1 Apr 2026
- Lead sponsor
- Changping Laboratory
- Diseases
- Autism
- NCT number
- NCT06255535
What you commit to
- Study type: Interventional
- Planned participants: 215
- From 1 Apr 2024 to the primary completion date, 1 Apr 2026
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Received transcranial magnetic stimulation (TMS), transcranial current stimulation (tCS), focused ultrasound (FUS), or other neuromodulation treatment in the last 3 months
Other illness
- 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)
- 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
Other
- 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
- All legal guardians are illiterate, unable to read informed documents or complete questionnaires independently
- Current participation in other clinical trials
Who the study is looking for
- 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
Age in the registry: 6 years to 30 years · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hebei Provincial Mental Health Center Coordinator of this site? Confirm its status | Baoding | China | Recruiting |
| Fujian Maternity and Child Health Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Recruiting |
| Fujian Children's Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Recruiting |
| Jining Medical University Coordinator of this site? Confirm its status | Jining | China | Recruiting |
| Linyi Hedong Rehabilitation Hospital Coordinator of this site? Confirm its status | Linyi | China | Recruiting |
| Xi'an TCM Hospital of Encephalopathy Coordinator of this site? Confirm its status | Xi'an | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.