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临床试验/NCT02177877
NCT02177877已完成不适用

A Biosensor for Tracking Seizures: Linking a Wrist Accelerometer to an Online Epilepsy Diary

Stanford University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2014年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Capture rate of convulsive seizure events by the watch and watch-diary interface compared to video electroencephalography (vEEG)

研究概览

简要总结

This study will assess whether a movement detecting wristwatch can accurately detect seizures and seizure characteristics and record them into an online epilepsy diary. The patients may manually record a description into the online epilepsy diary of the symptoms they experienced before, during or after the seizure.

详细描述

Typically, health care providers receive inaccurate patient self- reports. This pilot trial will document the feasibility of accurately recording and logging seizures into a cloud-based diary, under circumstances of controlled video-EEG monitoring to serve as a comparison "gold standard." More explicitly, we are testing the efficacy of the wristwatch in capturing movement parameters correlated with seizure activity and whether these parameters can be accurately uploaded into an online epilepsy diary. In the future, biosensor data could be valuable to more precisely obtain seizure data for clinical decision making as well as use in clinical trials.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults over the age of 18 with known epileptic convulsive seizures already being admitted to the EMU for continuous video EEG.

排除标准

  • Patients with only non-convulsive events or only psychogenic non-epileptic seizures.
  • Patients who are unable to provide consent.
  • Patients who have developmental delay.

结局指标

主要结局

Capture rate of convulsive seizure events by the watch and watch-diary interface compared to video electroencephalography (vEEG)

时间窗: up to 7 days

次要结局

  • Capture rate of non-seizure events by the watch and watch-diary interface compared to vEEG(up to 7 days)
  • Frequency of movements of the watch diary interface vs vEEG(up to 7 days)
  • Amplitude of movements of the watch diary interface vs vEEG(up to 7 days)
  • Seizure semiology captured by the watch vs vEEG.(up to 7 days.)
  • Specificity of audio recordings of the watch vs vEEG(up to 7 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Scheherazade Le

Principle Investigator

Stanford University

研究点 (1)

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