XLTCS - Accelerometer Data Collection in an Epilepsy Monitoring Unit (EMU)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- LivaNova
- 试验地点
- 1
- 主要终点
- Evaluate accelerometer data and tonic-clonic seizure data
研究概览
简要总结
The primary objective of this study is to collect accelerometer data from subjects monitored in an EMU with concurrent video EEG.
详细描述
XLTCS (LNE-800) is an international multicenter prospective data collection study to gather accelerometer data. The population under the study comprises patients monitored in an Epilepsy Monitoring Unit (EMU) with concurrent video EEG and who are expected to have at least one seizure with tonic-clonic convulsive movement.
A maximum of one hundred and fifty (150) patients will be enrolled and will wear an accelerometer, and up to 6 sites may participate in this study. The total enrollment period will take approximately 2 years.
Once the accelerometer was adhered to the subject, subjects will be followed for a minimum of 2 days and a maximum of 10 days.
Subject participation will run concurrently with the EMU admission. Exit from the study occurs when the subject's stay in the EMU is completed or the subject is withdrawn or withdraws from the study.
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
- 4 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Four (4) years of age or older.
- •Admitted to an Epilepsy Monitoring Unit for video EEG monitoring.
- •Based on medical history, expected to have at least one seizure with tonic-clonic convulsive movement during the EMU stay as determined by the investigator.
- •Capable of understanding and willing to comply with instructions and study procedures.
- •Subject or guardian must be willing and able to complete informed consent/assent.
排除标准
- •Based on medical history, expected to have only non-epileptic events during the EMU stay as determined by the investigator.
- •Based on medical history, known to have only absence seizures.
- •Medical or psychiatric condition that in the investigator's judgment would prevent the subject's successful completion of the study.
- •Participants with known hypersensitivity or skin sensitivity conditions that will preclude attachment of the accelerometer.
- •Participants who are also taking part in another clinical trial that could confound the results of the study; these patients can be included into the study only if LivaNova has provided written approval.
结局指标
主要结局
Evaluate accelerometer data and tonic-clonic seizure data
时间窗: 1.5 years
The study will evaluate accelerometer data and tonic-clonic seizure data that was collected during the patients' EMU admission. The sample size is not based on a statistical power calculation, thus no primary endpoint is defined in the clinical investigation plan.
次要结局
未报告次要终点