Transcranial Photobiomodulation With Near-Infrared Light for Language in Individuals With Down Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Change in Cambridge Neuropsychological Test Automated Battery
研究概览
简要总结
The aim of this study is to better understand the effects of transcranial photobiomodulation (tPBM) on neural oscillations of individuals diagnosed with Down syndrome.
详细描述
This study will compare the effect of tPBM to sham tPBM on gamma neural oscillations in the brain as assessed by EEG, and on language, attention and memory as assessed by neuropsychological testing. Participants will be randomized to either tPBM with near-infrared light (tPBM-NIR) or tPBM-Sham and will undergo 18 treatments (3 treatments per week for 6 weeks) in addition to baseline, short-term and long- term follow up visits.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 16 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in Cambridge Neuropsychological Test Automated Battery
时间窗: Baseline to Post-Treatment (~6 weeks)
Reaction Time, Paired Associative Learning, and Motor Screening Task subtests
Change in EEG
时间窗: Baseline to Post-Treatment (~6 weeks)
Gamma Power (40 Hz) of EEG Signal
Change in Wordless Picture Book
时间窗: Baseline to Post-Treatment (~6 weeks)
Standardized narrative sampling tasks that measure intelligibility, vocabulary, syntax and grammar of language
次要结局
未报告次要终点
研究者
Paolo Cassano
Principal Investigator
Massachusetts General Hospital