A Wireless EEG Patch for Continuous Electrographic Monitoring
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- Epitel, Inc.
- 入组人数
- 750
- 试验地点
- 5
- 主要终点
- Single channel EEG coherence
研究概览
简要总结
This proposal will evaluate an individual-use, patch-type telemetry device for simplified, single-channel EEG recording from human patients along-side the traditional in hospital wired EEG.
详细描述
Objectives:
The primary objectives of this study are to evaluate the devices ability: (1) to record wireless EEG from patients in the long-term EEG monitoring unit (2) compare wireless EEG in these recordings to standard-of-care wired EEG (3) to record wireless EEG from patients undergoing ambulatory EEG monitoring (4) compare wireless EEG in these recordings to the ambulatory EEG findings (5) develop automated seizure detection algorithms based on the data collected herein (6) develop real-time seizure alerting based on the data collected herein (7) record longitudinal EEG from Epilog outside of the epilepsy monitoring unit while patients answer daily questions through a mobile app designed to provide a probability of the patient having a seizure event.
Hypotheses:
- Single-channel EEG recorded with Epilog can be used to accurately detect seizures.
- Single-channel EEG recorded with Epilog can be used to alert to seizures in real time.
- Single-channel EEG recorded with Epilog can be used along with psychological, behavioral, and environmental input to a mobile app to create an hourly forecast of seizure probability.
Background:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previous diagnosis of Epilepsy or other seizure disorder
- •Admitted for scheduled EEG testing with a minimum of overnight (24 hour) EEG
- •5 years of age through adult
排除标准
- •Known or suspected allergy to adhesives
研究组 & 干预措施
Entire Study
Each patient is eligible for all interventions in the study.
干预措施: Observational only (Device)
Entire Study
Each patient is eligible for all interventions in the study.
干预措施: Psychological and Behavioral interaction with a seizure forecasting mobile app (Behavioral)
Entire Study
Each patient is eligible for all interventions in the study.
干预措施: Seizure Alerting and Prediction System (Combination Product)
结局指标
主要结局
Single channel EEG coherence
时间窗: Through study completion
Patient events noted in wired EEG will be measured against physician identified events in single channel EEG
Sensitivity and specificity for prospective seizure alerting
时间窗: Through study completion, 5 years
The second Phase of this program is to create a real-time automated seizure alerting system for both a participants personal mobile device as well as a caregiver/parent's personal mobile device.
Sensitivity and specificity for retrospect seizure detection
时间窗: Through Phase I completion, 2 years
The initial Phase of this program is the development and FDA clearance of an automated seizure detection system through a participants personal mobile device.
Sensitivity and specificity fro prospective seizure forecasting
时间窗: Through study completion, 5 years
The final Phase of this program is to create an hourly seizure prediction system that provides the participant with a probability of having an electrographic seizure based on physiological, psychological, behavioral, and environmental input.
次要结局
未报告次要终点