Study of Repetitive Transcranial Magnetic Stimulation with Language Training to Improve Language in Children Aged 2 to 5 With Global Developmental Delay

What this Trial Is About

Researchers are studying a new approach to improve language function in children aged 2 to 5 years with Global Developmental Delay GDD, a developmental disorder affecting multiple areas including language. The study aims to evaluate the effects of combining personalized language training with non-invasive, painless repetitive Transcranial Magnetic Stimulation rTMS targeted at brain regions responsible for language. About 50 children will participate in this randomized controlled trial conducted at Xiangxi Autonomous Prefecture Peoples Hospital. Participants will be randomly assigned to one of two groups. One group will receive personalized language training combined with high-frequency rTMS sessions, where magnetic pulses are delivered at 10 Hz with specific parameters for 20 minutes before each training session. The control group will receive only the individualized language training without rTMS. The intervention lasts for two weeks, followed by a two-week follow-up to assess the durability of any improvements. During the study, children will undergo language assessments using the Gesell Developmental Schedules to measure changes in language developmental quotient and the Sign-Significate Relations assessment to evaluate language developmental stage. Safety and tolerability will be monitored throughout the four-week period. The study includes baseline assessments at day 0, evaluations at the end of the two-week intervention, and again at the four-week follow-up to measure lasting effects of the combined therapy.

Repetitive Transcranial Magnetic Stimulation Combined With Language Training for Language Disorders in Children With Global Developmental Delay