This study explores a safe and effective new approach to assisting children with Global Developmental Delay (GDD) and comorbid language disorders. Conducted at Xiangxi Autonomous Prefecture People's Hospital, the study will recruit approximately 50 children aged 2 to 5 years. Participants will be randomly assigned to one of two groups: one receiving personalized language training combined with non-invasive, painless repetitive Transcranial Magnetic Stimulation (rTMS) to activate language regions of the brain, and a control group receiving personalized training alongside sham stimulation for comparative analysis. The study spans one month, including a two-week intervention period followed by a two-week follow-up to evaluate the efficacy and sustainability of the combined therapy. This study has been rigorously reviewed and approved by the hospital's Ethics Committee.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
One group of children received non-invasive, painless magnetic stimulation therapy to activate the brain's language centers alongside personalized language training. Another group received identical-looking sham magnetic stimulation combined with personalized language training for scientific comparison. The entire study will last approximately 1 months, including 2 weeks of treatment and 2 weeks of follow-up
Xiangxi Autonomous Prefecture People's Hospital, The intersection of Century Avenue and Jianxin Road in Qianzhou Sub-district, Jishou (416000), Hunan, China.
Jishou, Hunan, China
Change from Baseline in Language Developmental Quotient (DQ) via Gesell Developmental Schedules
The language subscale of the Gesell Developmental Schedules is used to evaluate a child's language development. The result is expressed as a Developmental Quotient (DQ), a continuous score where 100 represents performance at the exact chronological age level. A higher DQ indicates better language abilities.
Time frame: Baseline (Day 0), Week 2 (End of intervention), and Week 4 (Follow-up).
Change from Baseline in Language Developmental Stage via Sign-Significate Relations (S-S) Assessment
The S-S method is a standardized tool for the detailed diagnosis and classification of language developmental delay in children. It assesses both language comprehension and expression abilities, assigning the child to a specific developmental stage.The core outcome is the assigned Stage (I to V, with subdivisions). Higher stages indicate more advanced language development. For analysis, stages are often converted to an ordinal numerical score (e.g., Stage I=1, Stage II=2, etc.). The minimum score is 1 (lowest stage), and the maximum is 5 (highest stage).
Time frame: Baseline (Day 0), Week 2 (End of intervention), and Week 4 (Follow-up).
Number of Participants with the Systematic Assessment for Treatment of Emergent Events (SAFTEE) [Safety and Tolerability]
Safety will be assessed by recording the incidence and severity of all adverse events (AEs) reported during the study. AEs include but are not limited to: headache, dizziness, scalp discomfort, tinnitus, irritability, and seizures. Severity will be graded as mild, moderate, or severe.
Time frame: From the start of intervention (Day 1) through the final follow-up (Week 4).
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