Repetitive Transcranial Magnetic Stimulation Guided by Personalized Brain Functional Sectors (pBFS) for Low-Functioning Autism Spectrum Disorder: a Multi-center, Randomized, Sham-controlled Trial
Status: Recruiting
Location: See all (6) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 30
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
China
Hebei Provincial Mental Health Center
RECRUITING
Baoding
Fujian Children's Hospital
RECRUITING
Fuzhou
Fujian Maternity and Child Health Hospital
RECRUITING
Fuzhou
Jining Medical University
RECRUITING
Jining
Linyi Hedong Rehabilitation Hospital
RECRUITING
Linyi
Xi'an TCM Hospital of Encephalopathy
RECRUITING
Xi'an
Contact Information
Primary
Qi Liu, Ph.D.
liuqi@cpl.ac.cn
010-80726688
Time Frame
Start Date: 2024-04-01
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 215
Treatments
Experimental: active iTBS group
active iTBS over DLPFC
Sham_comparator: Sham group
sham iTBS over DLPFC
Related Therapeutic Areas
Sponsors
Collaborators: Hebei Provincial Mental Health Center, Jining Medical University, Linyi Hedong Rehabilitation Hospital, Fujian Children's Hospital, Xi'an TCM Hospital of Encephalopathy, Fujian Maternity and Child Health Hospital
Leads: Changping Laboratory