rTMS plus personalized language training to help preschoolers with global developmental delay improve speech and communication
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
This study tries non‑invasive repetitive transcranial magnetic stimulation (rTMS) together with personalized language training to improve language in children aged 2–5 with global developmental delay.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 2 Years to 5 Years |
| Sex | All |
| Sponsor | Xiangya Hospital of Central South University Academic / other |
| Locations | 1 site (Jishou, Hunan) |
| Trial ID | NCT07369960 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Children aged 2–5 with mild-to-moderate global developmental delay (language domain DQ ≤75 per Gesell and confirmed language delay on standardized S-S assessment), who can cooperate with rTMS and testing and whose legal guardian provides written consent are ideal candidates.
Not a fit: Children with a history of epilepsy or convulsive seizures, severe behavioral problems, severe GDD, or those unable to attend in-person sessions or tolerate rTMS are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this combined therapy could speed language development and improve everyday communication for preschool children with GDD.
How similar studies have performed: rTMS has shown promising language-rehabilitation effects in older children and adults, but evidence in very young children with GDD is limited and the combined rTMS-plus-language-training approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Jishou, Hunan
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.