Development of an Epileptic Seizure Detection Algorithm b... | NCT03369522

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

NCT03369522

Sponsor

University Hospital, Lille

Status

Completed

Last Update Posted

Dec 23, 2025Actual

Enrollment

40Actual

Phase

Not provided

Conditions

Seizures
Epilepsy
Electrocardiography

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2017-A00114-49	Other Identifier	ID-RCB number, ANSM

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 13, 2017Actual

Primary Completion Date

Dec 12, 2019Actual

Completion Date

Dec 12, 2019Actual

First Submitted Date

Dec 6, 2017

First Submission Date that Met QC Criteria

Dec 6, 2017

First Posted Date

Dec 12, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 16, 2025

Last Update Posted Date

Dec 23, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Construction		100 recordings that will be used for the algorithm development
Validation		100 recordings for the validation of the algorithm

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
William Szurhaj, MD,PhD	University Hospital, Lille	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ch Bethune		Béthune			France
Hôpital Roger Salengro, CHU

Condition Browse Module

MeSH Terms

ID	Term
D012640	Seizures
D004827	Epilepsy

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided