SeizuresEPICARDNCT03369522
Development of an Epileptic Seizure Detection Algorithm by Continuous Analysis of the Electrocardiogram
An observational study of Seizures and Epilepsy, run by University Hospital, Lille at 4 sites in France.
Trial summary
The aim of our project is to develop an epileptic seizure detection algorithm based on the the continuous analysis of the Electrocardiogram Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Seizures, Epilepsy, Electrocardiography
- How many people
- 40 participants
- Where
- 4 sitesFrance
- Study dates
- 13 Dec 2017to 12 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with epilepsy for whom a long-term video-EEG monitoring is required as part of their management
Who may be able to join
- 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
Who cannot join
- bad quality of the Electrocardiogram recording
- pace-maker
- non sinus rhythm
Trial locations and contacts
4 sites in 1 country.
France4 sites
Ch Bethune
Béthune
Hôpital Roger Salengro, CHU
Lille
Chu Amiens Salouël
Salouël
Ch de Valencienne
Valenciennes
About this study
The aim of our project is to develop an epileptic seizure detection algorithm based on the the continuous analysis of the Electrocardiogram
Read the 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
- Conditions
- Seizures, Epilepsy, Electrocardiography
- Keywords
- seizure detection
- Medical subject headings
- Seizures, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Construction | 100 recordings that will be used for the algorithm development | |
| Validation | 100 recordings for the validation of the algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
ROC curve for seizure detection
ROC curve gives the relation between detection probability and false alarm probability of the algorithm that will be developped
Measured: 24 months
Secondary outcomes (2)
Time of detection of seizures
Time of detection of seizures by the algorithm
Measured: 24 months
ROC curve for Psychogenic seizure detection
ROC curve for Psychogenic seizure detection
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2017
- Study start13 Dec 2017
- Primary completion12 Dec 2019
- Study completion12 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SeizuresStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William Szurhaj, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03369522
- Sponsor's protocol ID
- 2015_69
- Other IDs
- 2017-A00114-49
- Acronym
- EPICARD
- Status last verified
- Sep 2020
- First submitted
- 6 Dec 2017
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Epileptic Seizure Detection Algorithm by Continuous Analysis of the Electrocardiogram
- ClinicalTrials.gov ID
- NCT03369522
- Acronym / sponsor ID
- EPICARD / 2015_69
- Conditions
- Seizures, Epilepsy, Electrocardiography
- Keywords
- seizure detection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 13 Dec 2017 (actual)
- Primary completion
- 12 Dec 2019 (actual)
- Study completion
- 12 Dec 2019 (actual)
- First posted
- 12 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Construction | – | –100 recordings that will be used for the algorithm development |
| Validation | – | –100 recordings for the validation of the algorithm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with epilepsy for whom a long-term video-EEG monitoring is required as part of their management
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- bad quality of the Electrocardiogram recording
- pace-maker
- non sinus rhythm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Time of detection of seizures
Time frame: 24 months
ROC curve for Psychogenic seizure detection
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Szurhaj, MD,PhD principal investigator
University Hospital, Lille
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Seizures and Epilepsy, run by University Hospital, Lille at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ROC curve for seizure detection (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.