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NCT03369522 Clinical Trial

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
Phase
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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