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临床试验/NCT03465189
NCT03465189已完成不适用

Validation of a Seizure Monitoring System

St Vincent's Hospital Melbourne1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2018年9月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
10
试验地点
1
主要终点
Verify feasibility of using the LINQ device for epilepsy diagnosis, monitoring and management

研究概览

简要总结

The investigators aim to determine the feasibility of using the Medtronic LINQ device for epilepsy diagnosis, monitoring and management. The feasibility will be determined by comparing EEG signals from the LINQ system to the gold standard clinical recordings. If seizures can be identified using the LINQ device with the same level of accuracy as adjacent scalp EEG recording electrodes, then the LINQ will be deemed feasible.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with epilepsy

排除标准

  • Women that are pregnant
  • Patients that are highly dependant on medical care
  • Patients that cannot give informed consent for themselves

结局指标

主要结局

Verify feasibility of using the LINQ device for epilepsy diagnosis, monitoring and management

时间窗: one week

Compare EEG from traditional scalp EEG to the LINQ recordings to determine if seizure activity can be accurately identified

次要结局

未报告次要终点

研究者

发起方
St Vincent's Hospital Melbourne
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mark Cook

Principal Investigator

St Vincent's Hospital Melbourne

研究点 (1)

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Validation of a Seizure Monitoring System | 临床试验