Personalized TMS treatment for autism spectrum disorder
Personalized Brain Functional Sectors (pBFS) Guided Transcranial Magnetic Stimulation (TMS) Treatment for Autism Spectrum Disorder (ASD): a Sham-controlled, Double-blinded, Randomized Clinical Trial Study
NA · Changping Laboratory · NCT05890846
This study is testing a new brain treatment for children and young adults with autism to see if it can improve their cognitive control skills.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 6 Years to 30 Years |
| Sex | All |
| Sponsor | Changping Laboratory (other) |
| Locations | 2 sites (Zhengzhou, Henan and 1 other locations) |
| Trial ID | NCT05890846 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy and safety of personalized brain functional sectors (pBFS)-guided transcranial magnetic stimulation (TMS) treatment for children, adolescents, and young adults with autism spectrum disorder (ASD). By utilizing task-free functional MRI data, researchers will identify individualized brain areas related to cognitive control function, specifically targeting the left dorsal lateral prefrontal cortex. Participants will be randomly assigned to receive either active or sham TMS treatment over a 12-week period, with behavioral evaluations conducted at multiple points to assess treatment effects.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 6-30 years diagnosed with autism spectrum disorder who can participate in fMRI scans and follow study procedures.
Not a fit: Patients with severe self-injury, psychotic disorders, or other significant medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve cognitive control and social communication in individuals with autism spectrum disorder.
How similar studies have performed: While the use of TMS in treating ASD is being explored, this personalized approach using pBFS is relatively novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Nearest age 6-30 years old * Have the diagnosis of autism spectrum disorder * ADOS-2 score is higher than the ASD cut-offs * Capacity to follow the study procedures, including fMRI scan under sedation, assessment, and rehabilitation training * Participant's parent or other legal guardian give informed consent Exclusion Criteria: * Current or history of psychotic disorders, such as schizophrenia, schizoaffective disorder, bipolar disorder * Severe self-injury or suicidal behavior presented in the last one year * Severe visual, auditory, or motor disability that interferes with any study procedure * Current or history of seizure * Known severe physical diseases, such as congenital heart defect, traumatic brain injury * Metal implantations, which are contradicted by MRI or TMS, such as artificial cardiac pacemakers, stents, cochlear implants * Received TMS, tCS, FUS, or other neuromodulation treatment in the last 3 months * Currently participating in other clinical trials
Where this trial is running
Zhengzhou, Henan and 1 other locations
- Henan Provincial People's Hospital — Zhengzhou, Henan, China (RECRUITING)
- China Rehabilitation Research Center — Beijing, China (RECRUITING)
Study contacts
- Study coordinator: Qi Liu, Ph.D.
- Email: a0000153@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.
Conditions: Autism Spectrum Disorder, TMS, personalized medicine, ASD, fMRI