Precision neuromodulation for autism spectrum disorder
Repetitive Transcranial Magnetic Stimulation Guided by Personalized Brain Functional Sectors (pBFS) for Low-Functioning Autism Spectrum Disorder: a Multi-center, Randomized, Sham-controlled Trial
This study is testing a new brain stimulation treatment to see if it can help young people with autism and developmental delays feel better by reducing their core symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 215 (estimated) |
| Ages | 6 Years to 30 Years |
| Sex | All |
| Sponsor | Changping Laboratory Academic / other |
| Locations | 6 sites (Fuzhou, Fujian and 5 other locations) |
| Trial ID | NCT06255535 on ClinicalTrials.gov |
What this trial studies
This trial aims to evaluate the efficacy and safety of precision neuromodulation using intermittent theta burst stimulation (iTBS) to alleviate core symptoms in individuals with autism spectrum disorder (ASD) who also have intellectual or developmental delays. The treatment targets the left dorsolateral prefrontal cortex (DLPFC) guided by personalized Brain Functional Sector (pBFS) technology, utilizing task-free functional MRI scans for precise localization. Participants aged 6-30 will be randomly assigned to receive either active or sham iTBS over a 12-week period, with clinical evaluations conducted at baseline and after treatment to assess changes in ASD symptoms and related behaviors.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 6-30 diagnosed with autism spectrum disorder and comorbid intellectual disabilities, specifically with an IQ/DQ below 70.
Not a fit: Patients with genetic disorders, severe ADHD, or significant physical disabilities that hinder participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel treatment option for individuals with ASD and intellectual disabilities, potentially improving their quality of life.
How similar studies have performed: While TMS has shown promise in treating various psychiatric and neurological disorders, this specific application for ASD with precision targeting is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Fuzhou, Fujian and 5 other locations
- Fujian Children's Hospital — Fuzhou, Fujian, China (Recruiting)
- Fujian Maternity and Child Health Hospital — Fuzhou, Fujian, China (Recruiting)
- Hebei Provincial Mental Health Center — Baoding, Hebei, China (Recruiting)
- Xi'an TCM Hospital of Encephalopathy — Xi'an, Shaanxi, China (Recruiting)
- Jining Medical University — Jining, Shandong, China (Recruiting)
- Linyi Hedong Rehabilitation Hospital — Linyi, Shandong, China (Recruiting)
Study contacts
- Study coordinator: Qi Liu, Ph.D.
- Email: liuqi@cpl.ac.cn
- Phone: 010-80726688
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.