[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621387":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":33,"locations":39,"responsibleParty":59,"collaborators":62,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":25,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":25,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":25,"overallStatus":42,"whyStopped":25,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Xiangya Hospital of Central South University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13,14],"Behavioral: Transcranial magnetic stimulation","Behavioral: individualized language training",{"label":16,"type":17,"description":18,"interventionNames":19},"Control group","PLACEBO_COMPARATOR","Children in the control group will receive individualized language training.",[14],[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"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.",[9],null,{"type":22,"name":27,"description":27,"armGroupLabels":28,"otherNames":25},"individualized language training",[16,9],[30],{"name":31,"affiliation":5,"role":32},"Fangkun Liu, MD","PRINCIPAL_INVESTIGATOR",[34],{"name":35,"role":36,"phone":37,"phoneExt":25,"email":38},"Fangkun Liu, MD, MD","CONTACT","+86 15874290600","liufangkun@csu.edu.cn",[40],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"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","CN",{"type":49,"coordinates":50},"Point",[51,52],109.73346,28.31925,{"lat":52,"lon":51},[55],{"name":56,"role":36,"phone":57,"phoneExt":25,"email":58},"Shentang Li, MD","+86 18874093634","lstang0828@126.com",{"type":32,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"shenwailiufangkun","Associate professor",[63],{"name":64,"class":65},"Xiangxi Autonomous Prefecture People's Hospital","UNKNOWN","100621387","repetitive-transcranial-magnetic-stimulation-combined-with-language-training-for-language-disorders-in-children-with-global-developmental-delay-100621387",false,"NCT07369960","Repetitive Transcranial Magnetic Stimulation Combined With Language Training for Language Disorders in Children With Global Developmental Delay","Randomized Controlled Study for Repetitive Transcranial Magnetic Stimulation Combined With Language Training in Children With Language Disorders in Children With Global Developmental Delay","Inclusion criteria\n\n1. Children aged 2-5 years old, regardless of gender.\n2. 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.\n3. 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.\n4. The child is able to cooperate with the completion of rTMS treatment and language assessment and has no serious behavioral problems.\n5. Written informed consent obtained from the child's legal guardian. Exclusion Criteria\n\n1\\. 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.\n\n3\\. Other serious neurological conditions that may affect language function (e.g., cerebral palsy, progressive neurological disorders, etc.).\n\n4\\. 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 \\\u003C 40 in any developmental domains; other circumstances that prevented cooperation with the study.","ALL","2 Years","5 Years",{"count":77,"type":78},50,"ESTIMATED","INTERVENTIONAL",[81],"NA","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.",[84,85,86,87],"Developmental Delay Disorder","Repetitive Transcranial Magnetic Stimulation (rTMS)","Global Developmental Delay","Language Disorders in Children","2026-05-28",{"date":90,"type":91},"2026-06-02","ACTUAL",{"date":93,"type":78},"2026-05-27",{"date":95,"type":78},"2026-12-31",{"name":5,"class":6},1]