rTMS plus personalized language training to help preschoolers with global developmental delay improve speech and communication

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

About 50 children aged 2 to 5 with mild-to-moderate global developmental delay will be randomly assigned to receive either personalized language training plus real rTMS or personalized training plus sham (placebo) stimulation. The intervention period lasts two weeks, followed by a two-week follow-up to see if any gains persist. Language and developmental scales (including Gesell Developmental Schedules and standardized language measures) will be used to measure change. The protocol has been approved by the hospital ethics committee and is conducted at Xiangxi Autonomous Prefecture People's Hospital.

Why it matters

Who can join: the full rules

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.

Where it's running

• 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 Recruiting

Study contacts

• Principal investigator: Fangkun Liu, MD — Xiangya Hospital of Central South University
• Study coordinator: Fangkun Liu, MD, MD
• Email: liufangkun@csu.edu.cn
• Phone: +86 15874290600

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.