Development of an Epileptic Seizure Detection Algorithm by Continuous Analysis of the Electrocardiogram

• Conditions: Seizures; Electrocardiography; Epilepsy

• Registration Number: NCT03369522
• Lead Sponsor: University Hospital, Lille

Brief Summary

The aim of our project is to develop an epileptic seizure detection algorithm based on the the continuous analysis of the Electrocardiogram

Detailed Description

In a first step, the team will build a multi-parametric algorithm on existing records issued from the Epilepsy Monitoring Units. Each selected record will be analyzed by EMU medical team in order to detect seizure on the EEG. The algorithm will adapt in order to obtain the best sensitivity and specificity regarding seizure detection.

in a second step,algorithm will validate on a cohort of other recordings in patients with epilepsy

Study Timeline

• Study First Submitted: 2017-12-06
• Study First Submitted QC: 2017-12-06
• Study First Posted: 2017-12-12
• Study Start: 2017-12-13
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-10
• Last Update Posted: 2020-09-11
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• patients with epilepsy
• with a long-term video-EEG recording
• 1 (or more) seizure (s) recorded
• onset seizure clearly defined on the basis of the EEG

Exclusion Criteria

• bad quality of the Electrocardiogram recording
• pace-maker
• non sinus rhythm

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ROC curve for seizure detection	24 months	ROC curve gives the relation between detection probability and false alarm probability of the algorithm that will be developped

Secondary Outcome Measures

Name	Time	Method
Time of detection of seizures	24 months	Time of detection of seizures by the algorithm
ROC curve for Psychogenic seizure detection	24 months	ROC curve for Psychogenic seizure detection

Trial Locations

Locations (4)

Ch de Valencienne; 🇫🇷 Valenciennes, France

Chu Amiens Salouël; 🇫🇷 Salouël, France

Ch Bethune; 🇫🇷 Béthune, France

Hôpital Roger Salengro, CHU; 🇫🇷 Lille, France