NCT07369960 Repetitive Transcranial Magnetic Stimulation Combined With Language Training for Language Disorders in Children With Global Developmental Delay
| NCT ID | NCT07369960 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Xiangya Hospital of Central South University |
| Condition | Developmental Delay Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2026-05-27 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2026-05-27 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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. 5. Written informed consent obtained from the child's legal guardian. 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.
Contact & Investigator
Fangkun Liu, MD
PRINCIPAL INVESTIGATOR
Xiangya Hospital of Central South University
Frequently Asked Questions
Who can join the NCT07369960 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 5 Years, studying Developmental Delay Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07369960 currently recruiting?
Yes, NCT07369960 is actively recruiting participants. Contact the research team at liufangkun@csu.edu.cn for enrollment information.
Where is the NCT07369960 trial being conducted?
This trial is being conducted at Jishou, China.
Who is sponsoring the NCT07369960 clinical trial?
NCT07369960 is sponsored by Xiangya Hospital of Central South University. The principal investigator is Fangkun Liu, MD at Xiangya Hospital of Central South University. The trial plans to enroll 50 participants.