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Efficacy and Mechanism of Repetitive Transcranial Magnetic Stimulation in Children With Autism Spectrum Disorders
Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Summary
This study is a prospective, multicenter, randomized, single-blind controlled trial to enroll 200 children with autism spectrum disorders (ASD). The investigators hope to further explore the effectiveness of accelerated continuous theta-burst stimulation (a-cTBS) over the left primary motor cortex (M1) to improve core symptoms in ASD children based on a previous open-label clinical trial.
Official title: Efficacy and Mechanism of Repetitive Transcranial Magnetic Stimulation in Children With Autism Spectrum Disorders: a Multicenter, Randomized Controlled Trial
Key Details
Gender
All
Age Range
4 Years - 10 Years
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2023-07-04
Completion Date
2024-10-31
Last Updated
2026-05-19
Healthy Volunteers
No
Conditions
Interventions
repeated transcranial magnetic stimulation (continuous theta-burst stimulation)
Participants in intervention group will receive cTBS over the left M1for 5 consecutive days. The detailed parameters as follows: 80% of resting motor threshold (RMT), 60 cycles of 10 bursts of three pulses at 50 Hz were delivered in 2-second trains (5 Hz) with no intertrain interval (i.e. triplet standard cTBS, 1800 pulses, 120s). Stimulation sessions were delivered hourly, 10 sessions were applied per day (18,000 pulses/day).
sham repeated transcranial magnetic stimulation
The sham group will be stimulated with a pseudo-stimulation coil, which emitted sounds with the same intensity, rhythm and vibratory sensation as the real stimulation, and the intervention target, duration and frequency are the same as the real intervention group.
Locations (3)
Henan Children's Hospital
Zhengzhou, Henan, China
Qilu Hospital of Shandong University
Qilu, Shandong, China
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China