pBFS Guided rTMS Over Cognitive Control Network for ASD
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Autism Spectrum Disorder
In brief
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.
Key facts
- Study ID
- NCT06255535
- Run by
- Changping Laboratory
- People needed
- 215
- Starts
- 2024-04-01
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2025-02-21
Who can join
Age: 6 and older, up to 30. Sex: any. Healthy volunteers: not accepted.
You may qualify 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
- Participant's parents or other legal guardians give informed consent
You may not qualify if…
- 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
Where it is running
- Fujian Children's Hospital — Fuzhou, Fujian, China (enrolling)
- Fujian Maternity and Child Health Hospital — Fuzhou, Fujian, China (enrolling)
- Hebei Provincial Mental Health Center — Baoding, Hebei, China (enrolling)
- Xi'an TCM Hospital of Encephalopathy — Xi'an, Shaanxi, China (enrolling)
- Jining Medical University — Jining, Shandong, China (enrolling)
- Linyi Hedong Rehabilitation Hospital — Linyi, Shandong, China (enrolling)
Full record on ClinicalTrials.gov
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