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

Epilepsy Clinical Trial

— EPICARD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03369522
• Other study ID #: 2015_69
• Secondary ID: 2017-A00114-49
• Status: Recruiting
• Start date: December 13, 2017
• Est. completion date: December 2021

Study information

• Verified date: September 2020
• Source: University Hospital, Lille
• Contact: William Szurhaj, MD,PhD
• Phone: 320 44 60 74
• Email: william.szurhaj[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Electrocardiography
• Epilepsy
• Seizures

Locations

Country	Name	City	State
France	Ch Bethune	Béthune
France	Hôpital Roger Salengro, CHU	Lille
France	Chu Amiens Salouël	Salouël
France	Ch de Valencienne	Valenciennes

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ROC curve for seizure detection	ROC curve gives the relation between detection probability and false alarm probability of the algorithm that will be developped	24 months
Secondary	Time of detection of seizures	Time of detection of seizures by the algorithm	24 months
Secondary	ROC curve for Psychogenic seizure detection	ROC curve for Psychogenic seizure detection	24 months