Randomized Controlled Study for Repetitive Transcranial Magnetic Stimulation Combined With Language Training in Children With Language Disorders in Children With Global Developmental Delay
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change from Baseline in Language Developmental Quotient (DQ) via Gesell Developmental Schedules
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 2 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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) ≤
- •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.
排除标准
- •1. History of epilepsy or convulsive seizures.
- •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.
- •Have a severe hearing or visual impairment.
- •Participation in other clinical trials that may affect speech function.
- •Skin lesions or infection at the scalp treatment site.
- •The fontanelle has not yet closed.
- •Previous rTMS treatment in the last 3 months.
- •Developmental quotient < 40 in any developmental domains; other circumstances that prevented cooperation with the study.
研究组 & 干预措施
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. 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.
干预措施: Transcranial magnetic stimulation (Behavioral)
结局指标
主要结局
Change from Baseline in Language Developmental Quotient (DQ) via Gesell Developmental Schedules
时间窗: Baseline (Day 0), Week 2 (End of intervention), and Week 4 (Follow-up).
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.
次要结局
- Change from Baseline in Language Developmental Stage via Sign-Significate Relations (S-S) Assessment(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](From the start of intervention (Day 1) through the final follow-up (Week 4).)
研究者
shenwailiufangkun
Associate professor
Xiangya Hospital of Central South University