Actively Recruiting
pBFS Guided rTMS Over Cognitive Control Network for ASD
Led by Changping Laboratory · Updated on 2025-02-21
215
Participants Needed
6
Research Sites
139 weeks
Total Duration
On this page
Sponsors
C
Changping Laboratory
Lead Sponsor
X
Xi'an TCM Hospital of Encephalopathy
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
pBFS Guided rTMS Over Cognitive Control Network for ASD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 6 and 30 years old
- Diagnosed with autism spectrum disorder
- ADOS-2 score above ASD cut-offs
- Comorbid intellectual disorder with IQ/DQ less than 70
- Primary environmental language is Chinese
- Informed consent given by participant's parents or legal guardians
You will not qualify if you...
- Genetic disorders such as Down syndrome, Fragile X syndrome, or Rett syndrome
- Current or past severe ADHD, Tourette syndrome, or psychotic disorders like schizophrenia, schizoaffective disorder, or bipolar disorder
- Severe self-injury or suicidal behavior within the past year
- Significant visual, auditory, deafness, or motor disabilities preventing study participation
- Current or history of epilepsy
- Known severe physical diseases, especially those affecting the brain
- Metal implants incompatible with MRI or TMS, such as pacemakers, stents, or cochlear implants
- Respiratory or circulatory conditions increasing sedation risk, including apnea syndrome or severe snoring
- Legal guardians are illiterate or unable to read consent documents or complete questionnaires independently
- Received TMS, transcranial current stimulation, focused ultrasound, or other neuromodulation treatments within the last 3 months
- Currently participating in other clinical trials
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Fujian Children's Hospital
Fuzhou, Fujian, China
Actively Recruiting
2
Fujian Maternity and Child Health Hospital
Fuzhou, Fujian, China
Actively Recruiting
3
Hebei Provincial Mental Health Center
Baoding, Hebei, China
Actively Recruiting
4
Xi'an TCM Hospital of Encephalopathy
Xi'an, Shaanxi, China
Actively Recruiting
5
Jining Medical University
Jining, Shandong, China
Actively Recruiting
6
Linyi Hedong Rehabilitation Hospital
Linyi, Shandong, China
Actively Recruiting
Research Team
Q
Qi Liu, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here