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临床试验/NCT04439656
NCT04439656已完成不适用

Detecting Absence Seizures Using Eye Tracking

Rachel Kuperman5 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2020年7月15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
150
试验地点
5
主要终点
Eysz algorithm to detect absence seizures

研究概览

简要总结

The goal of this study is to develop a comfortable system that uses a wearable eye-tracker similar to eyeglasses to assist people with epilepsy in counting and measuring the severity of seizures. Participants will wear an eye-tracker during a routine EEG.

详细描述

Seizures can be difficult to detect outside of the hospital even with careful observation by a caregiver. EEG is the best method that we have to detect seizures- but it is uncomfortable for long term use outside of the hospital. The goal of this study is to develop a comfortable system that uses a wearable eye-tracker similar to eyeglasses to assist people with epilepsy in counting and measuring the severity of seizures. People participating in this study will have a routine EEG performed while an eye tracker measures eye movements. After the EEG is complete the researchers will compare the eye movements to the EEG to develop a software program that can detect seizures from eye movements.

研究设计

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

入排标准

年龄范围
4 Years 至 100 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Provision of signed and dated informed consent form- per local IRB
  • Stated willingness to comply with all study procedures including the clicker test and availability for the duration of the study
  • Male or female, aged 4-100
  • Experience known typical absence seizures as defined by the ILAE 2017 classification or referred to EEG lab for staring spell or concern for absence seizure
  • a. This will allow for inclusion of children and adults across the entire spectrum of disease states including new diagnosis (medication naive), medication responsive and non-medication responsive
  • Scheduled for clinical EEG observation

排除标准

  • Intolerant of wearing or unable to wear the eyeglasses
  • Autism or other developmental disorder that the PI thinks will interfere with data collection
  • History of aggression that the PI thinks will interfere with data collection
  • History of not tolerating EEG that the PI thinks will interfere with data collection
  • Unable to give consent (for individuals ≥ 18 years old) unless they have an adult with power of attorney to consent

结局指标

主要结局

Eysz algorithm to detect absence seizures

时间窗: 1 hour

EEG is burdensome and limited. The current accepted method of counting seizures is observation which fails to identify \> 50% of seizures. The goal is to validate the Eysz absence seizure detection algorithm and show significant improvement over current standard of care

次要结局

未报告次要终点

研究者

发起方
Rachel Kuperman
申办方类型
Industry
责任方
Sponsor Investigator
主要研究者

Rachel Kuperman

Director, Clinical Research

Eysz, Inc.

研究点 (5)

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