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RECRUITINGNA

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

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

NCT07369960•Xiangya Hospital of Central South University

View on ClinicalTrials.gov

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.

Eligibility

Age

2 - 5 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Children aged 2-5 years old, regardless of gender.
•2. 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.
•3. 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.
•4. The child is able to cooperate with the completion of rTMS treatment and language assessment and has no serious behavioral problems.

Exclusion Criteria

•1\. History of epilepsy or convulsive seizures. 2. Having metal implants in the skull (e.g. aneurysm clips, metal stents, etc.) and electronic devices such as pacemakers and cochlear implants in the body.
•3\. Other serious neurological conditions that may affect language function (e.g., cerebral palsy, progressive neurological disorders, etc.).
•4\. Have a diagnosis of ASD. 5. Have a severe hearing or visual impairment. 6. Participation in other clinical trials that may affect speech function. 7. Skin lesions or infection at the scalp treatment site. 8. The fontanelle has not yet closed. 9. Previous rTMS treatment in the last 3 months. 10. Developmental quotient \< 40 in any developmental domains; other circumstances that prevented cooperation with the study.

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

Key Dates

Start Date

February 1, 2026

Primary Completion Date

December 31, 2026

Completion Date

December 31, 2026

Last Updated

February 19, 2026

Enrollment

ESTIMATED participants

Conditions

Developmental Delay DisorderRepetitive Transcranial Magnetic Stimulation (rTMS)Global Developmental DelayLanguage Disorders in Children

Interventions

Transcranial magnetic stimulation

BEHAVIORAL

Contacts

Fangkun Liu, MD, MD

CONTACT

+86 15874290600 liufangkun@csu.edu.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 19, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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