NCT03369522

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 12, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

December 13, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2019

Completed
Last Updated

December 23, 2025

Status Verified

September 1, 2020

Enrollment Period

2 years

First QC Date

December 6, 2017

Last Update Submit

December 16, 2025

Conditions

SeizuresEpilepsyElectrocardiography

Keywords

seizure detection

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Time of detection of seizures

    24 months

  • ROC curve for Psychogenic seizure detection

    24 months

Study Arms (2)

Construction

100 recordings that will be used for the algorithm development

Validation

100 recordings for the validation of the algorithm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Ch Bethune

Béthune, France

Location

Hôpital Roger Salengro, CHU

Lille, France

Location

Chu Amiens Salouël

Salouël, France

Location

Ch de Valencienne

Valenciennes, France

Location

MeSH Terms

Conditions

SeizuresEpilepsy

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBrain DiseasesCentral Nervous System Diseases

Study Officials

  • William Szurhaj, MD,PhD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2017

First Posted

December 12, 2017

Study Start

December 13, 2017

Primary Completion

December 12, 2019

Study Completion

December 12, 2019

Last Updated

December 23, 2025

Record last verified: 2020-09

Locations

FR(4)