Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03369522
Recruitment Status : Recruiting
First Posted : December 12, 2017
Last Update Posted : September 11, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The aim of our project is to develop an epileptic seizure detection algorithm based on the the continuous analysis of the Electrocardiogram

Condition or disease
Seizures Epilepsy Electrocardiography

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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development of an Epileptic Seizure Detection Algorithm by Continuous Analysis of the Electrocardiogram
Actual Study Start Date : December 13, 2017
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Time of detection of seizures [ Time Frame: 24 months ]
    Time of detection of seizures by the algorithm

  2. ROC curve for Psychogenic seizure detection [ Time Frame: 24 months ]
    ROC curve for Psychogenic seizure detection


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03369522


Contacts
Layout table for location contacts
Contact: William Szurhaj, MD,PhD 320 44 60 74 ext +33 william.szurhaj@chru-lille.fr

Locations
Layout table for location information
France
Ch Bethune Recruiting
Béthune, France
Principal Investigator: Isabelle LAVENU, MD         
Hôpital Roger Salengro, CHU Recruiting
Lille, France
Principal Investigator: William SZURHAJ, MD         
Chu Amiens Salouël Recruiting
Salouël, France
Principal Investigator: Bertille PERRIN, MD         
Ch de Valencienne Recruiting
Valenciennes, France
Principal Investigator: Marie-Pierre PERRIOL, MD         
Sponsors and Collaborators
University Hospital, Lille
Investigators
Layout table for investigator information
Principal Investigator: William Szurhaj, MD,PhD University Hospital, Lille
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03369522    
Other Study ID Numbers: 2015_69
2017-A00114-49 ( Other Identifier: ID-RCB number, ANSM )
First Posted: December 12, 2017    Key Record Dates
Last Update Posted: September 11, 2020
Last Verified: September 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
seizure detection
Additional relevant MeSH terms:
Layout table for MeSH terms
Epilepsy
Seizures
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations