Tests magnetic brain stimulation in people with autism and developmental delay
Tests magnetic brain stimulation against a sham treatment in people with autism.
Plain-language title generated from the registry record
Registry title: pBFS Guided rTMS Over Cognitive Control Network for ASD
Key facts
- Where
- Baoding, Fuzhou, Jining, Linyi, and Xi'an, ChinaSee the 6 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 6 and 30 years old?
Source: NCT06255535, who can take part
Where in China
- Hebei Provincial Mental Health CenterBaoding, ChinaTaking people
- Fujian Children's HospitalFuzhou, ChinaTaking people
- Fujian Maternity and Child Health HospitalFuzhou, ChinaTaking people
- Jining Medical UniversityJining, ChinaTaking people
- Linyi Hedong Rehabilitation HospitalLinyi, ChinaTaking people
- Xi'an TCM Hospital of EncephalopathyXi'an, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Changping Laboratory
- Trial code
- NCT06255535
- Record updated
- 21 February 2025
- Original description
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.Read full original descriptionShow less
Repetitive Transcranial Magnetic Stimulation Guided by Personalized Brain Functional Sectors (pBFS) for Low-Functioning Autism Spectrum Disorder: a Multi-center, Randomized, Sham-controlled Trial
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.
Inclusion: 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: Received transcranial magnetic stimulation (TMS), transcranial current stimulation (tCS), focused ultrasound (FUS), or other neuromodulation treatment in the last 3 months; 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; 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.