Forecasting Seizures Using IntelliGent Wearable Technology for Health Tracking
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 3,000
- 试验地点
- 2
- 主要终点
- Sensitivity of SeizureWise
研究概览
简要总结
The goal of this interventional study is to develop a personalized seizure risk forecast tool in people with epilepsy.
The main questions it aims to answer are:
- can we develop a future seizure probabilities tool that is more accurate than chance based on the pattern and frequency of previous generalized tonic-clonic seizure (GTCS) events, as well as changes in physiological and behavioral variables.
- does this tool improve the lives of people with epilepsy?
Researchers will compare a group that does not have access to the forecast tool to a group that does and see if it is accurate and if people with it report that it improved their quality of life.
详细描述
The primary goal of the study is to demonstrate the accuracy of SeizureWise in predicting the timing of future convulsive seizures using data collected by the wearable EmbracePlus device and data provided by patients with GTCS monitored in outpatient settings.
The secondary goals are:
to assess the clinical impact of SeizureWise on quality of life (QoL), psychological health indicators, and economic and clinical outcomes to assess the clinical impact of visualizing behavioral and physiologic data without forecasting predictions on quality of life (QoL), psychological health indicators, and economic and clinical outcomes
A non-significant risk, open-label, prospective, randomized clinical investigation designed to evaluate the ability of SeizureWise to forecast GTCS occurrence and to assess impact on QoL and seizure management outcomes.
The study will include two phases during which an algorithm based on sensor derived physiological measures is developed and tested with output blinded to the participant. In a final phase participants will be randomized to two arms, one of which will have access to a seizure forecasting risk score.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must be diagnosed with or be at risk of epilepsy
- •Subjects or their parents or guardians must understand and consent to be in the study;
- •Subjects or their parents or guardians must be able to read and communicate in English;
- •Subjects or their parents or guardians must be willing and able to comply with study procedures and duration;
- •Subjects must have a wrist circumference suitable for wearing the EmbracePlus device.
排除标准
- •Subjects, or their parents or guardians for minor study participants, who do not understand the study and the risks;
- •Subjects, or their parents or guardians for minor study participants, who are either physically or cognitively incapable of performing study activities (e.g. filling in surveys and daily e-diary);
- •Subjects who would be placed at undue medical risk associated with any procedure called for in the protocol; or
- •Subjects that are Empatica employees and actively participated in the development of this protocol or development of the Seizure Wise algorithms.
研究组 & 干预措施
Control
The control arm will receive multi-day visualizations of their sensor derived data but not receive SeizureWise
干预措施: Multi-day Visualizations (Device)
Personalized seizure risk score
The personalized seizure risk score arm will receive multi-day visualization of their sensor derived data and also SeizureWise, an investigational algorithm which enables forecasting of future seizure probabilities based on the pattern and frequency of previous generalized tonic-clonic seizure (GTCS) events, as well as changes in physiological and behavioral variables
干预措施: SeizureWise algorithm (Device)
Personalized seizure risk score
The personalized seizure risk score arm will receive multi-day visualization of their sensor derived data and also SeizureWise, an investigational algorithm which enables forecasting of future seizure probabilities based on the pattern and frequency of previous generalized tonic-clonic seizure (GTCS) events, as well as changes in physiological and behavioral variables
干预措施: Multi-day Visualizations (Device)
结局指标
主要结局
Sensitivity of SeizureWise
时间窗: 2 years
Percentage of patients with (1) sensitivity of high-likelihood warnings greater than 60% and (2) superior to a rate-matched forecast (or superior baselining method) at the end of Phase 2.
次要结局
- Change in QoL and psychological health indicators using the Quality of life in epilepsy (QOLIE-10-P)(2 years)
- Qualitative assessment of multi-day visualizations(2 years)
- Modifiable behavior change(2 years)
- Stress level with visualizations using the brief epilepsy anxiety survey instrument (brEASI-8)(2 years)
- Accuracy of SeizureWise low-likelihood forecast(2 years)
- Accuracy of SeizureWise high-likelihood forecast(2 years)