Improving Spatiotemporal Precision in Noninvasive Electrical Neuromodulation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Slow wave duration
研究概览
简要总结
Compare closed-loop with open-loop application of TES to enhance slow waves of sleep.
详细描述
Note: FDA has determined that TES with the stimulus parameters as specified for this trial presents no significant risk, so that FDA clearance is not required.
Several findings suggest that Transcranial Electrical Stimulation (TES) may be particularly effective if it is aligned with ongoing brain activity. One condition of the present research is an open-loop design, in which TES pulses (0.75 Hz pulses; 2.0 mA) are presented during slow wave sleep. The other condition is a closed-loop design, using identical pulses, but these will be phase aligned with the slow waves of sleep, measured by the electroencephalogram (EEG). The hypothesis is that closed-loop TES will be more effective in enhancing the amplitude and duration of slow wave sleep than open-loop TES.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The phase alignment of the treatment is set in software and not revealed to participant or experimenter. Order of treatment is randomized and counterbalanced.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy adults
排除标准
- •persons with epilepsy
研究组 & 干预措施
Open-Loop
In this arm of this repeated measures (within subjects) design, the participants receive electrical neuromodulation (TES) that is not synchronized to their slow waves of sleep. The Transcranial Electrical Stimulation (TES) is 2 mA applied in 100 ms pulses at 0.75 Hz.
干预措施: Transcranial Electrical Neuromodulation (TES) (Device)
Closed-Loop
In this arm of this repeated measures (within subjects) design, the participants receive electrical neuromodulation (TES) that is synchronized to their slow waves of sleep. The Transcranial Electrical Stimulation (TES) is 2 mA applied in 100 ms pulses at 0.75 Hz.
干预措施: Transcranial Electrical Neuromodulation (TES) (Device)
结局指标
主要结局
Slow wave duration
时间窗: Slow Wave Duration will be assessed in minutes for the night of sleep (defined as 8 hours). The dependent measure for the statistical test will be the duration (in minutes) of slow wave stage N3 sleep for the study night.
Duration of slow wave period in sleep
Slow wave amplitude
时间窗: Slow Wave Amplitude will be assessed during the night of sleep (defined as 8 hours). The dependent measure for the statistical test will be slow wave amplitude expressed per minute of stage N3 sleep for the study night.
Amplitude of slow waves of sleep
次要结局
未报告次要终点
研究者
Don M. Tucker
CEO, Senior Scientist
Brain Electrophysiology Laboratory Company