Tests magnetic brain stimulation in people with autism and developmental delay
Tests magnetic brain stimulation against a sham treatment in people with autism.
Key facts
- Who runs it
- Changping Laboratory
- Where
- Baoding, Fuzhou, Jining, Linyi, and Xi'an, ChinaSee the 6 sites
- Trial code
- Registry title
- pBFS Guided rTMS Over Cognitive Control Network for ASD
- Status
- Recruiting
- People taking part
- 215 people, planned
- Started
- 1 Apr 2024
- Expected to end
- 1 Dec 2026
- Type of study
- Interventional, 2 groupsOne group gets a sham (pretend) treatment, for comparison.
- Treatments tested
- active iTBS treatment
- sham iTBS treatment
- Record updated
- 21 February 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people aged 6 to 30 with autism spectrum disorder and an intellectual or developmental delay (IQ/DQ below 70). It tests a brain stimulation treatment against a sham treatment.
- Age
- 6 to 30 years
- Sex
- All sexes can join.
- Disease stage
- Autism spectrum disorder confirmed by an ADOS-2 score above the ASD cut-offs, together with an intellectual disorder (IQ/DQ below 70).
- Earlier treatment
- Cannot have had TMS, tCS, focused ultrasound or other brain stimulation treatment in the last 3 months.
Main reasons for not taking part
- Genetic disorders such as Down syndrome, Fragile X syndrome or Rett syndrome
- Epilepsy now or in the past
- Severe self-injury or suicidal behaviour within the past year
- Metal implants that are not safe with MRI or TMS, such as pacemakers or cochlear implants
- Taking part in another clinical trial now
The registry criteria, word for word
Show all 16 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Check if you might fit
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?
Where in China
- Hebei Provincial Mental Health CenterBaoding, ChinaContact: Qi Liu, Ph.D.Taking people
- Fujian Children's HospitalFuzhou, ChinaContact: Qi Liu, Ph.D.Taking people
- Fujian Maternity and Child Health HospitalFuzhou, ChinaContact: Qi Liu, Ph.D.Taking people
- Jining Medical UniversityJining, ChinaContact: Qi Liu, Ph.D.Taking people
- Linyi Hedong Rehabilitation HospitalLinyi, ChinaContact: Qi Liu, Ph.D.Taking people
- Xi'an TCM Hospital of EncephalopathyXi'an, ChinaContact: Feng GaoTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- active iTBS groupTreatment being tested
active iTBS over DLPFC
Treatment: active iTBS treatment
- Sham groupSham treatment, for comparison
sham iTBS over DLPFC
Treatment: sham iTBS treatment
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Repetitive Transcranial Magnetic Stimulation Guided by Personalized Brain Functional Sectors (pBFS) for Low-Functioning Autism Spectrum Disorder: a Multi-center, Randomized, Sham-controlled Trial
- Plain-language title
- Tests magnetic brain stimulation in people with autism and developmental delayGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06255535, who can take part
- Record updated
- 21 February 2025