Actively Recruiting
Repetitive Transcranial Magnetic Stimulation Combined With Language Training for Language Disorders in Children With Global Developmental Delay
Led by Xiangya Hospital of Central South University · Updated on 2026-02-19
50
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
Sponsors
X
Xiangya Hospital of Central South University
Lead Sponsor
X
Xiangxi Autonomous Prefecture People's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 alongside sham stimulation 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.
CONDITIONS
Official Title
Repetitive Transcranial Magnetic Stimulation Combined With Language Training for Language Disorders in Children With Global Developmental Delay
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 2 to 5 years, any gender
- Diagnosed with Global Developmental Delay according to China's 2024 guidelines, confirmed by Gesell Developmental Schedules
- Language Developmental Quotient (DQ) of 75 or below in at least one of four domains: gross motor, fine motor, adaptive behavior, or personal-social conduct
- Significant language developmental delay confirmed by standardized Sign-Significate Relations assessment
- Ability to cooperate with rTMS treatment and language assessments
- Written informed consent from the child's legal guardian
You will not qualify if you...
- History of epilepsy or convulsive seizures
- Presence of metal implants in the skull or electronic devices such as pacemakers or cochlear implants
- Other serious neurological conditions affecting language, such as cerebral palsy or progressive neurological disorders
- Diagnosis of Autism Spectrum Disorder
- Severe hearing or visual impairment
- Participation in other clinical trials affecting speech function
- Skin lesions or infections at the scalp treatment site
- Open fontanelle (not yet closed)
- Prior rTMS treatment within the last 3 months
- Developmental quotient below 40 in any developmental domain
- Any other condition preventing cooperation with the study
AI-Screening
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Trial Site Locations
Total: 1 location
1
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, 416000
Actively Recruiting
Research Team
F
Fangkun Liu, MD, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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