Breathing Rescue for SUDEP Prevention (BreatheS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in percentage of breathing node size as assessed by electroencephalogram (EEG) signal
研究概览
简要总结
The purpose of this study is to precisely delineate human brain networks that modulate respiration and identify specific brain areas and stimulation techniques that can be used to prevent seizure-induced breathing failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of intractable focal epilepsy
- •admitted to the Epilepsy Monitoring Unit (EMU) at Memorial Hermann-Texas Medical Center for intracranial subdural strips, grids, or depth electrode placement study (invasive video-EEG)
排除标准
- •respiratory, cardiac or cerebrovascular disease
- •pregnancy
- •prisoners
结局指标
主要结局
Change in percentage of breathing node size as assessed by electroencephalogram (EEG) signal
时间窗: baseline (before breathing task), at the time of the breathing task (about 8 minutes after start of baseline)
Change in presence of breathing nodes as assessed by EEG signal
时间窗: Baseline (before breathing task), at the time of the breathing task(about 8 minutes after start of baseline)
Changes in thoracoabdominal circumference during stimulation as assessed by thoracoabdominal belts,
时间窗: Baseline, during the stimulation session (at least 2 hours after baseline)
Lower and higher frequencies up to 50 Hertz(Hz), current of 1-10 milli ampere (mA), pulse durations of 0.2 milli second (msec) and stimulation periods of 10 to 40 seconds will be used.
Changes airflow during stimulation as assessed by the nasal/oral pressure transducer [BiNAPS]
时间窗: Baseline, during the stimulation session (at least 2 hours after baseline)
Lower and higher frequencies up to 50Hz, current of 1-10mA, pulse durations of 0.2 msec and stimulation periods of 10 to 40 seconds will be used.
Change in Saturation of peripheral oxygen (SpO2) during stimulation as assessed by the pulse oximetry
时间窗: Baseline, during the stimulation session (at least 2 hours after baseline)
Lower and higher frequencies up to 50Hz, current of 1-10mA, pulse durations of 0.2 msec and stimulation periods of 10 to 40 seconds will be used.
Change in end tidal carbon dioxide (CO2) during stimulation
时间窗: Baseline, during the stimulation session (at least 2 hours after baseline)
Lower and higher frequencies up to 50Hz, current of 1-10mA, pulse durations of 0.2 msec and stimulation periods of 10 to 40 seconds will be used.
次要结局
- Quantification of the breathing changes as assessed by the change in breathing depth(baseline (before stimulation), at the time of stimulation (about 8 minutes after start of baseline))
- Quantification of the breathing changes as assessed by the change in breathing rate(baseline (before stimulation), at the time of stimulation (about 8 minutes after start of baseline))
- Quantification of the breathing changes as assessed by the change in breathing minute ventilation (MV)(baseline (before stimulation), at the time of stimulation (about 8 minutes after start of baseline))
研究者
Nuria Lacuey Lecumberri
Assistant Professor
The University of Texas Health Science Center, Houston