An interventional study of Transcranial magnetic stimulation and individualized language training in Developmental Delay Disorder, Repetitive Transcranial Magnetic Stimulation (rTMS) and Global Developmental Delay, sponsored by Xiangya Hospital of Central South University. Recruiting at 1 site in China. Open to participants aged 2 Years to 5 Years. Per ClinicalTrials.gov, last updated 2026-06-02.
Sponsored by Xiangya Hospital of Central South University · Not applicable, Interventional, and Treatment
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.
230 studies on the registry are indexed under Developmental Disabilities; 65 are open to participants now.
This study's planned enrollment of 50 is below the median of 60 across 150 interventional studies indexed under Developmental Disabilities.
Browse Developmental Disabilities studies →Xiangya Hospital of Central South University is the lead sponsor of 174 studies on the registry; 77 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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. It will be administered 5 minutes prior to individualized language training to take advantage of the post-stimulation "time window" and potentially enhance training efficacy.
Behavioral: Transcranial magnetic stimulation · Behavioral: individualized language training
Children in the control group will receive individualized language training.
Behavioral: individualized language training
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.
individualized language training
Change from Baseline in Language Developmental Quotient (DQ) via Gesell Developmental Schedules
The language subscale of the Gesell Developmental Schedules is used to evaluate a child's language development. The result is expressed as a Developmental Quotient (DQ), a continuous score where 100 represents performance at the exact chronological age level. A higher DQ indicates better language abilities.
Time frame: Baseline (Day 0), Week 2 (End of intervention), and Week 4 (Follow-up).
Change from Baseline in Language Developmental Stage via Sign-Significate Relations (S-S) Assessment
The S-S method is a standardized tool for the detailed diagnosis and classification of language developmental delay in children. It assesses both language comprehension and expression abilities, assigning the child to a specific developmental stage.The core outcome is the assigned Stage (I to V, with subdivisions). Higher stages indicate more advanced language development. For analysis, stages are often converted to an ordinal numerical score (e.g., Stage I=1, Stage II=2, etc.). The minimum score is 1 (lowest stage), and the maximum is 5 (highest stage).
Time frame: Baseline (Day 0), Week 2 (End of intervention), and Week 4 (Follow-up).
Number of Participants with the Systematic Assessment for Treatment of Emergent Events (SAFTEE) [Safety and Tolerability]
Safety will be assessed by recording the incidence and severity of all adverse events (AEs) reported during the study. AEs include but are not limited to: headache, dizziness, scalp discomfort, tinnitus, irritability, and seizures. Severity will be graded as mild, moderate, or severe.
Time frame: From the start of intervention (Day 1) through the final follow-up (Week 4).
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for May 2026; primary completion for Dec 2026, 7 months later.
Of 96 non-industry interventional studies with no phase under Developmental Disabilities, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 49. This study's planned 7 months is below that.
Counting every sponsor, half of 97 studies reached it within 22 months; a quarter within 13 and three quarters within 49.
How these figures are worked out, and which studies are left out of them.
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Xiangya Hospital of Central South University →