RecruitingNot ApplicableNCT07369960

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

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


Sponsor

Xiangya Hospital of Central South University

Enrollment

50 participants

Start Date

May 27, 2026

Study Type

INTERVENTIONAL

Conditions

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 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.


Eligibility

Min Age: 2 YearsMax Age: 5 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a behavioral approach called Transcranial magnetic stimulation and a behavioral approach called individualized language training for people with developmental delay disorder, global developmental delay, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 2 Years to 5 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BEHAVIORALTranscranial magnetic stimulation

The stimulation protocol consists of the following parameters: frequency of 10 Hz, intensity at 80% of the resting motor threshold (RMT), 30 pulses per train, 3-second train duration, and a 17-second inter-train interval. Each session comprises 1800 pulses in total, lasting 20 minutes. In addition to language training, participants will receive High-Frequency rTMS as a group-specific intervention. The rTMS will be administered 5 minutes prior to each language training session to leverage the post-stimulation "time window" and potentially enhance training efficacy. The entire study will last approximately 1 months, including 2 weeks of treatment and 2 weeks of follow-up.

BEHAVIORALindividualized language training

individualized language training


Locations(1)

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07369960


Related Trials