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
- 1
- 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
- •for this study include:
- •adult men and women between the ages of 16 and 35
- •diagnosis of DS (i.e., clinical diagnosis of Trisomy 21 or Complete Unbalanced Translocation of Chromosome 21)
排除标准
- •for this study include:
- •diagnosis of seizure disorder
- •diagnosis of dementia
- •inability to complete study procedures
- •English as a second language
- •speech as the secondary mode of communication
- •speech of less than two-word utterances
- •changes in medications, augmentative devices, and other intervention two weeks prior to baseline testing and throughout study completion at PI's discretion
- •untreated obstructive sleep apnea (OSA)
- •Participation in other clinical research trials that may influence affect primary outcomes or adherence to the proposed study, as assessed by the PI and the Co-Is
- •candidates who have a current diagnosis of cancer and/or are currently undergoing treatment for cancer
- •history of migraine with an aura in the past 6 months
- •current pregnancy
研究组 & 干预措施
Near-Infrared Transcranial Photobiomodulation (tPBM-NIR)
tPBM-NIR involves the use of a device that administers near-infrared light over the scalp. The light activates target brain regions.
干预措施: Near-Infrared Transcranial Photobiomodulation (Device)
Sham Transcranial Photobiomodulation (tPBM-Sham)
tPBM-Sham involves the use of an identical device to tPBM-NIR but does not administer near-infrared light. It mimics the sensation by applying heat but does not actually activate target regions of the brain
干预措施: Sham Transcranial Photobiomodulation (Device)
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