RecruitingNot Applicable

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

China50 participantsStarted 2026-02-01

Plain-language summary

This study explores a safe and effective new approach to improve language function in children with Global Developmental Delay (GDD). 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.

Who can participate

Age range2 Years – 5 Years

SexALL

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Inclusion criteria

✓. Children aged 2-5 years old, regardless of gender.
✓. Meet the diagnostic definition of GDD in China's Diagnostic Guidelines for Global Developmental Delay (2024), confirmed by Gesell Developmental Schedules (GDS). Language domain Developmental Quotient (DQ) ≤ 75. A DQ ≤ 75 is found in at least one of the four developmental domains: gross motor, fine motor, adaptive behavior, and personal-social conduct. Mild-moderate GDD is selected for the study.
✓. The presence of significant language developmental delay, the language ability is significantly lower than children of the same age and the same intellectual level, confirmed by the standardized scale of Sign-Significate Relations (S-S) assessment.
✓. The child is able to cooperate with the completion of rTMS treatment and language assessment and has no serious behavioral problems.

What they're measuring

Change from Baseline in Language Developmental Quotient (DQ) via Gesell Developmental Schedules

Timeframe: Baseline (Day 0), Week 2 (End of intervention), and Week 4 (Follow-up).

Trial details

NCT IDNCT07369960

SponsorXiangya Hospital of Central South University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

Fangkun Liu, MD, MD

+86 15874290600 liufangkun@csu.edu.cn

View on ClinicalTrials.gov More Developmental Delay Disorder trials