Repetitive Transcranial Magnetic Stimulation Combined With Language Training for Language Disorders in Children With Global Developmental Delay
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transcranial magnetic stimulation, individualized language training.
- Who it may be relevant to
- Registry conditions: Developmental Delay Disorder, Repetitive Transcranial Magnetic Stimulation (rTMS), Global Developmental Delay, Language Disorders in Children. Basic parameters: 2 years — 5 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Randomized Controlled Study for Repetitive Transcranial Magnetic Stimulation Combined With Language Training in Children With Language Disorders in Children With Global Developmental Delay
Overview
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.
Interventions
- Behavioral Transcranial magnetic stimulation
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 pos - Behavioral individualized language training
individualized language training
Primary outcome measures
- Change from Baseline in Language Developmental Quotient (DQ) via Gesell Developmental Schedules [Time frame: Baseline (Day 0), Week 2 (End of intervention), and Week 4 (Follow-up).]
Secondary outcome measures (2)
- Change from Baseline in Language Developmental Stage via Sign-Significate Relations (S-S) Assessment [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] [Time frame: From the start of intervention (Day 1) through the final follow-up (Week 4).]
Eligibility criteria
Inclusion criteria
- Children aged 2-5 years old, regardless of gender.
- 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.
- 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.
- The child is able to cooperate with the completion of rTMS treatment and language assessment and has no serious behavioral problems.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Xiangxi Autonomous Prefecture People's Hospital, The intersection of Century Avenue and Ji — Jishou
Identifiers
NCT: NCT07369960 · EC-LCKY2025078