NCT06669364尚未招募不适用
Retrospective Analysis of Routine EEG to Validate a Computational Biomarker (BioEP) as an Assessment Aid for Seizure Susceptibility.
Neuronostics Ltd0 个研究点目标入组 400 人开始时间: 2025年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 400
- 主要终点
- To validate BioEP during routine adult EEG recording in an outpatient setting, using patients with a known diagnosis
研究概览
简要总结
The goal of this retrospective study is to validate BioEP during routine adult EEG recording in an outpatient setting, using patients with a known epilepsy diagnosis. The main objectives of the study are:
- To validate BioEP during routine adult EEG recording in an outpatient setting, using patients with a known diagnosis
- To examine whether the use of BioEP could support a more efficient patient pathway to diagnosis (thus adding economic value), by reducing time to final diagnosis and/or the number of clinical appointments needed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (age 22 and above) who had a routine EEG in an outpatient setting, following a suspected seizure.
- •A diagnosis of epilepsy or alternate condition has been reached. A period of at least 3 years has passed since ultimate diagnosis, which itself has remained stable.
- •EEGs performed to ABRET & IFCN standards using a minimum of 19 electrodes and additional technical requirements.
排除标准
- •Subject was not suspected of having had a seizure or epilepsy.
- •Subject has a dual diagnosis of epilepsy AND non-epileptic seizures.
- •Subject's final diagnosis unknown, unstable, or less than three years passed since an unchanged diagnosis was made.
- •Incomplete or unreliable metadata, such as the age, sex, and treatment status at the time of the EEG recording.
- •Sleep deprived EEG recordings in the outpatient setting.
- •Encephalopathic subjects.
- •Poor quality EEGs (multiple artefacts) that do not fulfil technical criteria for analysis.
- •Known structural abnormalities or skull breaches, including historical cases, or with people with metal or plastic implants in their brain or skull.
结局指标
主要结局
To validate BioEP during routine adult EEG recording in an outpatient setting, using patients with a known diagnosis
时间窗: 6 months
Diagnostic accuracy, defined by a primary endpoint family1 of two ranked endpoints. Specifically, we are testing whether BioEP has superior sensitivity to initial EEG alone and is no worse than EEG alone for specificity (non-inferiority). These are ranked hypotheses with sensitivity taking precedence (fixed sequence method) . That is, we shall only proceed to comparing specificity if sensitivity is superior.
次要结局
- To examine whether the use of BioEP could support a more efficient patient pathway to diagnosis(6 months)
研究者
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