Neuroliten MVP System Clinical Observation Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Respiratory Rate
研究概览
简要总结
This is an observational study for data collection from subjects diagnosed with Epilepsy/intractable seizures. The Neuroliten MVP System will not be used for patient management or treatment decisions.
详细描述
Neuroliten MVP system stores the data obtained from wearables, caregivers, and all audio/video recording of seizure activity that the caregiver captures associated with a seizure episode.
The primary objective of this study is to obtain vital signs and neurological indicators via the Neuroliten MVP System to correlate to the onset of seizures that are detected by the observations of family/caregivers.
The secondary objective is to identify the vital signs and/or neurological indicators that are associated with seizure onset.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •An Institutional Review Board (IRB) approved informed consent is signed and dated before any study-related activities.
- •Male and female subjects ages 18 to 75, inclusive.
- •Documented history of at least two (2) seizures per week. Seizures can be generalized and/or focal.
- •Diagnosed with intractable or refractory epilepsy.
- •Have a caregiver/family member who stays with the subject, has the ability to detect seizures, and is willing to provide the information needed for the study.
- •Have implanted vagus nerve stimulation (VNS).
- •Have the ability to understand the requirements of the study and are willing to comply with all study requirements.
- •Must have a working Apple iPhone.
排除标准
- •Women who are either pregnant or breastfeeding.
- •Subjects unable/unwilling to wear the Apple Watch and EEG Wearable for extended periods.
- •Requires the use of a ventilator.
- •Requires the use of supplemental oxygen.
- •Uses a pacemaker or other electronic neurostimulator, except the VNS.
- •Any medical or surgical condition that in the opinion of the investigator may interfere with participation in the study.
结局指标
主要结局
Respiratory Rate
时间窗: 90 days
Respiratory Rate (breaths per minute)
Heart Rate
时间窗: 90 days
Heart Rate (beats per minute)
Oxygen Saturation
时间窗: 90 days
Oxygen Saturation (SpO2 %)
Blood Pressure
时间窗: 90 days
Blood Pressure (mmHg)
Temperature
时间窗: 90 days
Temperature (Fahrenheit)
Brain Signals
时间窗: 90 Days
Brain signals obtained using a 14-channel EEG Wearable
次要结局
- Clinical Observations from Caregiver(90 days)