Impact of Capturing Ictal Events With Ultra-long-term Ambulatory EEG Monitoring With REMI.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Epitel, Inc.
- 入组人数
- 65
- 试验地点
- 4
- 主要终点
- Ictal Events Identified in fourteen (14) days.
研究概览
简要总结
The goal of this clinical trial is to test Epitel's™ Remote EEG Monitoring System's (REMI™) ability to record electroencephalography (EEG) of seizure events in an ambulatory setting for extended periods (14 - 28 days) in patients presenting with questionable seizure characterization. The main questions it aims to answer are: • Can more seizure events be recorded in fourteen (14) days than can be recorded in three (3) days? • Do treating clinicians find clinical value in extended fourteen (14) - twenty-eight (28) days of EEG? Participants will wear a portable EEG device (REMI) for fourteen (14) to twenty-eight (28) days in their home/community setting.
详细描述
This is a prospective study to quantify Epitel's™ Remote EEG Monitoring System's (REMI™) ability to record electroencephalography (EEG) of seizure events in an ambulatory setting for extended periods (14 - 28 days). Patients presenting with questionable seizure characterization that are scheduling a conventional at home ambulatory EEG (Amb EEG) and who meet the study inclusion and exclusion criteria will be prescribed a REMI system.
The purpose of this study is to demonstrate that the REMI system is able to record EEG data that clinicians can use to identify ictal events over extended periods, and that extended clinical EEG data is valuable in the diagnosis and treatment of seizure related symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients have a reported history of seizures (epileptic, non-epileptic, or unknown),
- •Have a minimum reported seizure rate of one every two weeks,
- •Are prescribed an ambulatory EEG study as part of routine care,
- •Is Male or Female between the ages of 18 and 70,
- •Can understand and sign written informed consent, or have a legal guardian provide consent,
- •The Patient (or Primary Caregiver) must be competent to follow all study procedures,
- •The Patient must be willing to use the System for a prolonged period (up to 30 days), for a minimum of 20 hours/day.
排除标准
- •Is sensitive or allergic to medical acrylics, silicones, or hydrogels,
- •Is enrolled in another investigational drug or device trial,
- •Is homeless or in a home without a power supply, or
- •Cannot read, speak, or understand English (and does not have a translator).
结局指标
主要结局
Ictal Events Identified in fourteen (14) days.
时间窗: Fourteen (14) days
Epileptiform seizure activity as identified by three independent board-certified epileptologists assessing data collected by REMI. The number of seizures identified in the first three days will be compared to the number of seizures identified during days one (1) to fourteen (14).
次要结局
- Extended Use(Twenty-eight (28) days)