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

September 10, 2020 updated by: University Hospital, Lille
The aim of our project is to develop an epileptic seizure detection algorithm based on the the continuous analysis of the Electrocardiogram

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Béthune, France
        • Recruiting
        • CH Bethune
        • Principal Investigator:
          • Isabelle LAVENU, MD
      • Lille, France
        • Recruiting
        • Hôpital Roger Salengro, CHU
        • Principal Investigator:
          • William SZURHAJ, MD
      • Salouël, France
        • Recruiting
        • Chu Amiens Salouël
        • Principal Investigator:
          • Bertille PERRIN, MD
      • Valenciennes, France
        • Recruiting
        • Ch de Valencienne
        • Principal Investigator:
          • Marie-Pierre PERRIOL, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with epilepsy for whom a long-term video-EEG monitoring is required as part of their management

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Construction
100 recordings that will be used for the algorithm development
Validation
100 recordings for the validation of the algorithm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ROC curve for seizure detection
Time Frame: 24 months
ROC curve gives the relation between detection probability and false alarm probability of the algorithm that will be developped
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time of detection of seizures
Time Frame: 24 months
Time of detection of seizures by the algorithm
24 months
ROC curve for Psychogenic seizure detection
Time Frame: 24 months
ROC curve for Psychogenic seizure detection
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Investigators

  • Principal Investigator: William Szurhaj, MD,PhD, University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2017

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

December 6, 2017

First Submitted That Met QC Criteria

December 6, 2017

First Posted (Actual)

December 12, 2017

Study Record Updates

Last Update Posted (Actual)

September 11, 2020

Last Update Submitted That Met QC Criteria

September 10, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015_69
  • 2017-A00114-49 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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