A Pivotal, Phase II Trial of Detecting Generalized Tonic-Clonic Seizures With a Seizure Detection and Warning System in Epilepsy Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Test the function of the system including ability to acquire EMG signal, analyze and successfully transmit the analysis to the base station, and identify and transmit all alert conditions.
研究概览
简要总结
This is a phase III, pilot, prospective study of an Electromyography (EMG) based seizure detection system for detecting Generalized Tonic-Clonic Seizures (GTCS) in the home.
详细描述
The Brain Sentinel™ Seizure Detection and Warning System is intended for monitoring children and adults with a history or significant risk of generalized tonic-clonic seizures in the home or healthcare facilities, during the titration or withdrawal of anti-epileptic drugs, and for continuous monitoring (night time or any other time of day) of individuals due to their history or risk of generalized tonic-clonic seizures. The device will withstand activities of daily living including showers and sleep.
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
- 2 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has a history of GTC seizures, either primary GTC or partial onset seizures with secondary generalization.
- •Male or female between the ages of 2-
- •Has an upper arm circumference which is adequate for proper fit of the EMG monitor (at least 14cm).
- •Be able to tolerate wearing the device on the upper arm.
- •If female and of childbearing potential, has a negative pregnancy test.
- •Can understand and sign written informed consent, or will have a parent or a legally authorized representative (LAR) who can do so, prior to the performance of any study assessments.
- •Subject and/or Primary Caregiver must be competent to follow all study procedures.
- •Is able to read, speak and understand English.
排除标准
- •Does not have a documented history of generalized seizures.
- •The subject's upper arm circumference not adequate for proper fit of the EMG monitor (less than 14cm)
- •Pregnant female
- •Subject/Caregiver is unable to provide consent.
- •Subject/Caregiver is not competent to follow home study procedures.
- •The subject is homeless or in a home without a power supply.
结局指标
主要结局
Test the function of the system including ability to acquire EMG signal, analyze and successfully transmit the analysis to the base station, and identify and transmit all alert conditions.
时间窗: up to 1 month
The overall usability and technical features will be assessed through questionnaires and surveys as the Seizure Detection and Warning System will be used within a home setting.
次要结局
- Compare the accuracy of the EMG based system's log to the subject's seizure diary(up to one month)