Clinical Validation of Criteria for Identification of Epileptiform Electroencephalography Discharges in Sensor Space and Source Space
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 主要终点
- Inter-rater Agreement of the International Federation of Clinical Neurophysiology (IFCN) Criteria (Cut-off=4) in Sensor Space and of Detection of Epileptiform Discharges (EDs) in Source Space
研究概览
简要总结
Electroencephalography (EEG) records electric activity of the brain using electrodes placed on the scalp. EEG is an important tool in the diagnostic work-up of patients with epilepsy. Specific types of sharp EEG discharges (epileptiform discharges) are associated with patients with epilepsy.
The International Federation of Clinical Neurophysiology (IFCN) has recently published a set of six operational criteria for identifying epileptiform discharges. At least four criteria need to be present in order to classify a discharge as epileptiform. These criteria are largely based on expert opinion and have not been validated yet. It is not clear what the sensitivity and specificity of these criteria are, and which combination of these criteria are optimal. Each criterion is based on visual assessment. However, it is not known what the inter-rater agreement of these criteria are.
EEG is traditionally inspected in sensor space, i.e. in the recording channels. Advances in signal analysis made possible reconstructing the electric currents in the regions of the brain generating them, and displaying the signals in the source space, instead of the sensor space.
The objectives of this study are: to determine the inter-rater agreement of the IFCN criteria by visual analysis in sensor space, to determine the combination of criteria with the best accuracy (sensitivity and specificity) and assess the accuracy of evaluating the discharges in source space.
The raters will analyze EEG recordings from 100 patients, from two groups: consecutive patients with epilepsy and consecutive patients with non-epileptic paroxysmal episodes. EEG was recorded during long-term video-EEG monitoring. As reference standard, the investigators used the evaluation of the patients´ habitual clinical episode. The performance of the criteria in sensor-space and the analysis in source space will be compared with the unrestricted expert scorings.
详细描述
Epilepsy affects 50 million people of all ages. It is the most common neurologic disorder across the lifespan, and has been found to be associated with an increased risk of mortality compared to the general population.
EEG is an important tool in the diagnostic work-up of patients with suspected epilepsy. The presence of epileptiform EEG discharges (EDs) confirm the diagnosis and provides important information that helps in classifying epilepsy.
EDs are visually identified by experts with training in reading EEG. Although EDs were defined in the previous edition of the IFCN glossary of terms, that definition was conceptual, and the inter-rater agreement for identifying EDs was only moderate. Recently, the IFCN suggested the following operational definition for EDs: Transients distinguishable from background activity with a characteristic morphology; EDs have to fulfill at least 4 of the following 6 criteria:
- Di- or tri-phasic waves with sharp or spiky morphology (i.e. pointed peak).
- Different wave-duration than the ongoing background activity: either shorter or longer.
- Asymmetry of the waveform: a sharply rising ascending phase and a more slowly decaying descending phase, or vice versa.
- The transient is followed by an associated slow after-wave.
- The background activity surrounding epileptiform discharges is disrupted by the presence of the epileptiform discharges.
- Distribution of the negative and positive potentials on the scalp suggests a source of the signal in the brain, corresponding to a radial, oblique or tangential orientation of the source. This is best assessed by inspecting voltage maps constructed using common-average reference.
However, these criteria are largely based on expert opinion. Data from clinical validation studies are lacking, thus it is not known what the sensitivity and specificity of these methods are. The threshold of four fulfilled criteria was arbitrary, and it is not sure whether it yields the optimal accuracy (sensitivity and specificity). Furthermore, since each criterion is based on visual evaluation, it is not known whether all experts would reach the same conclusion.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who underwent long-term video-EEG monitoring
- •Patients who had at least one habitual episode (seizure) recorded on video and EEG.
- •Patients with sharp transients.
- •For patients with epilepsy: the interictal (epileptiform) sharp transients are concordant with the ictal recording
排除标准
- •Patients with both epileptic seizures and non-epileptic seizures (paroxysmal episodes).
结局指标
主要结局
Inter-rater Agreement of the International Federation of Clinical Neurophysiology (IFCN) Criteria (Cut-off=4) in Sensor Space and of Detection of Epileptiform Discharges (EDs) in Source Space
时间窗: 1 year
Inter-rater agreement of IFCN criteria (cut-off=4) in sensor space and of detection of EDs in source space was calculated using Gwet´s Agreemen Coefficient (AC1). We calculated Gwet's coefficients of agreement AC1 for beyond chance agreement, because, compared with Cohen's Kappa, the Gwet's agreement coefficient is less affected by prevalence and marginal probability and thereby avoids the problem known as the "paradoxes of kappa". Strength of agreement beyond chance was interpreted according to Landis and Koch criteria: poor (\<0), slight (0·01-0·20), fair (0·21-0·40), moderate (0·41-0·60), substantial (0·61-0·80), and almost perfect (0·81-1·00).
Sensitivity and Specificity IFCN Criteria (Cut-off=4)
时间窗: 1 year
This is a diagnostic study, hence sensitivity and specificity must be calculated from different groups: sensitivity form the group of patients with epilepsy and specificity from the gruoup of patients who do not have epilepsy. Sensitivity: the percentage of patients with abnormal index test (true positives) among patients with epilepsy. Specificity: the percentage of patients with normal index test (true negatives) among patients who do not have epilepsy.
The Sensitivity and Specificity of Detecting EDs in Source-space
时间窗: 1 year
This is a diagnostic study, hence sensitivity and specificity must be calculated from different groups: sensitivity form the group of patients with epilepsy and specificity from the group of patients who do not have epilepsy. Sensitivity: the percentage of patients with abnormal index test (true positives) among patients with epilepsy. Specificity: the percentage of patients with normal index test (true negatives) among patients who do not have epilepsy.
次要结局
未报告次要终点
研究者
Sándor Beniczky
professor
Aarhus University Hospital
