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临床试验/NCT04171934
NCT04171934已完成不适用

Clinical Validation of a Video-based Epilepsy Examination Service

Tampere University1 个研究点 分布在 1 个国家目标入组 182 人开始时间: 2019年6月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
182
试验地点
1
主要终点
FDR (per hour) and TPR

研究概览

简要总结

The main purpose of this study is to validate the ability of the Nelli system (video-based epilepsy examination system) to detect epileptic motor seizure behaviors in patients at rest.

详细描述

Proper seizure documentation is an important tool to evaluate treatment outcomes and risks associated with epileptic seizures. Apart from a costly in-hospital video electro-encephalogram (VEEG) monitoring, most patients with epilepsy log and track their seizures with the help of the seizure diaries only. However, the reliability of the diaries is heavily dependent on an accurate recognition and recording of the seizures. There is an obvious need for a more objective and reliable seizure detection method. The investigators propose a low-cost video-based examination system, designed to detect motor seizure behaviors in patients at rest.

The main aim of this study is to clinically validate the ability of the Nelli system (video-based epilepsy examination system) to detect epileptic motor seizure behaviors in patients at rest, using simultaneous VEEG as the ground truth with the reference to all motor seizures and individual motor seizure types.

Study design established as follows:

  1. Study population is represented by 90 epilepsy patients with suspected history of motor seizures undergoing a standard VEEG examination for clinical evaluation of epilepsy.

  2. Co-registration of standard VEEG with the Nelli video- and audio-based system is performed, duration of the registration is 1-4 days.

  3. The inclusion criteria for seizures:

  4. Epileptic motor seizures appearing from rest while patients are in supine position in their monitoring bed.

  5. The seizures are determined to be epileptic based on electroclinical characteristics by the responsible neurophysiologist / epileptologist.

  6. The seizures can be classified into motor seizure types (both focal and generalized) using the 2017 International League Against Epilepsy (ILAE) seizure classification.

  7. The registrations are analyzed by the Nelli system blinded to any clinical information. Nelli system consists of two evaluation components:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Patients with epilepsy undergoing a standard VEEG examination for clinical evaluation consenting to participate in the present study

排除标准

  • •Patients not consenting to participate in the study

结局指标

主要结局

FDR (per hour) and TPR

时间窗: Examination period specific to the patient (1-4 days)

False detection rate (FDR/hour) as well as true positive rate (TPR) of the Nelli service is to be evaluated. Here FDR stands for detections which do not intersect with the ground truth events, and true positive events match ground truth with the Nelli detections.

次要结局

  • Latency (seconds)(Examination period specific to the patient (1-4 days))
  • Inter-rater agreement (Cohen's kappa coefficient)(Examination period specific to the patient (1-4 days))
  • Performance of the algorithmic component(Examination period specific to the patient (1-4 days))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jukka Peltola

Professor, Department of Neurology

Tampere University

研究点 (1)

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