A Pivotal, Phase III 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
- 入组人数
- 239
- 试验地点
- 1
- 主要终点
- Primary outcome is accuracy of device to detect GTC seizures when compared to video EEG.
研究概览
简要总结
The seizure detection and warning system is an ambulatory system designed to monitor and analyze EMG data to detect the onset of GTC seizures and to provide a warning signal to alert caregivers that a seizure is occurring.
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
- 13 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has a suspected history of GTC seizures, either primary GTC or partial onset seizures with secondary generalization.
- •Is being admitted to a hospital for routine vEEG monitoring related to seizures.
- •Male or female between the ages of 13-
- •If female and of childbearing potential, has a negative pregnancy urine test, and must also not be nursing.
- •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 or has a LAR that does so.
- •Subject/LAR consents to the use of vEEG files, including video/audio recordings, for purposes of this research study.
排除标准
- •Has not had a GTC seizure within the last year AND is not expected to have a reduction of anti-epileptic drugs during their hospital admission.
- •Intracranial EEG electrodes are being used.
- •The subject is allergic to adhesives or any component of the electrode patch assembly
结局指标
主要结局
Primary outcome is accuracy of device to detect GTC seizures when compared to video EEG.
时间窗: less than 1 month
The primary objective of the research is to determine the ability of the Brain Sentinel Seizure Detection System to accurately detect GTC seizures in comparison to the recognized "gold standard" for seizure detection, video Electroencephalography (vEEG).The primary endpoint will be the sensitivity of GTC seizure detection (defined as within 30 seconds of motor manifestation via vEEG analysis) in a hospital setting.
次要结局
- Comparison of study device to self reporting of seizures using a seizure diary.(Less than 1 month)