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| Name | Class |
|---|---|
| Xiangxi Autonomous Prefecture People's Hospital | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcranial magnetic stimulation | Experimental | 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. |
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| Control group | Placebo Comparator | Children in the control group will receive individualized language training. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial magnetic stimulation | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (Day 0), Week 2 (End of intervention), and Week 4 (Follow-up). |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fangkun Liu, MD, MD | Contact | +86 15874290600 | liufangkun@csu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Fangkun Liu, MD | Xiangya Hospital of Central South University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiangxi Autonomous Prefecture People's Hospital, The intersection of Century Avenue and Jianxin Road in Qianzhou Sub-district, Jishou (416000), Hunan, China. | Recruiting | Jishou | Hunan | 416000 | China |
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The language therapists providing individualized training and the outcome assessors conducting language evaluations will all be blinded to group allocation. Outcome assessors will have no involvement in the randomization or intervention processes.
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| individualized language training | Behavioral | individualized language training |
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| 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. | From the start of intervention (Day 1) through the final follow-up (Week 4). |
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| ID | Term |
|---|---|
| D002658 | Developmental Disabilities |
| D007859 | Learning Disabilities |
| ID | Term |
|---|---|
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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