EpilepsyDetecTeppeNCT05637762
Development of a Seizure Detection Algorithm Based on Heart Rate and Movement Analysis
An observational study of Epilepsy, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
Epilepsy is the 3rd neurological pathology after migraines and dementia syndromes with a high estimate of nearly 600,000 people affected in France. The disease is characterized by the repetition of epileptic seizures on the one hand, but also by the cognitive, behavioral, psychological and social consequences of this… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- - EEG video recording or extension of an EEG video recording planned as part of the care - Wearing a connected heart rate and motion recording patch
- How many people
- 13 participants
- Where
- 1 siteFrance
- Study dates
- 5 Jun 2023to 24 Apr 2025
- 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: The people with epilepsy will be recruited from among the patients/residents being followed for their epilepsy at the Institut La Teppe. Institut La Teppe is a medical and social institution that welcomes people suffering from epilepsy with cognitive deficiencies that can be severe.
Who may be able to join
- Person over 18 years of age - With drug-resistant epilepsy as defined by the International League Against Epilepsy
- Who has at least one recorded seizure with heart rate variation (i.e. tachycardia defined as an increase of 30 bpm or more than 50% over the interictal heart rate and/or bradycardia defined as a heart rate < 40 bpm or ictal asystole defined as an R-R interval greater than 3 seconds and usually lasting less than 60 seconds)
- Informed about the study and signed a consent to participate in the study (and their legal representative for patients under guardianship)
- Affiliated or beneficiary of a social insurance plan
Who cannot join
- Pregnant or breastfeeding woman
- Persons with psychogenic non-epileptic seizures (PNES)
- Person with a history of severe heart disease (myocardial infarction, heart failure, rhythm disorder, severe hypertension)
- Persons with an implantable cardiac device (pacemaker, implantable defibrillator)
- Documented allergy to hydrogel and/or acrylate
- Person benefiting from a legal protection measure other than guardianship or curatorship
Trial locations and contacts
1 site in 1 country.
About this study
Epilepsy is the 3rd neurological pathology after migraines and dementia syndromes with a high estimate of nearly 600,000 people affected in France. The disease is characterized by the repetition of epileptic seizures on the one hand, but also by the cognitive, behavioral, psychological and social consequences of this condition, especially when the epileptic disease is not stabilized. Epileptic patients feel a great deal of stress due to the unpredictability of the occurrence of seizures.
Seizure detection is of great interest to bioinformatics researchers and to people with epilepsy and their caregivers. Recent advances in physiological sensor technologies and artificial intelligence have opened the possibility of developing systems capable of closely monitoring the frequency of epileptic seizures with a direct impact on therapeutic adaptations. This may eventually allow for seizure prediction and/or "seizure weather" (i.e., seizure forecasting) if there is a particular chronotype of seizure occurrence for a given individual.
Read more
Currently, few devices have a sufficient level of evidence regarding their effectiveness to be recommended. Those that seem to be the most advanced are those that allow the identification of hypermotor seizures, including tonic-clonic generalized seizures and tonic-clonic secondary generalized focal seizures, mostly occurring at night. The latter represent only a small part of epileptic seizures.
The objective of the present study is to build a real life database in order to develop a seizure detection algorithm.
The recorded data will be heart rate via ECG and movement data via 9 variables measured on 3 axes x, y, z, with 3 sensors: accelerometer, gyroscope, magnetometer. These data will be collected using a connected patch available on the market (CE marking).
At the same time, the patients will benefit from a long term video-EEG examination which will be annotated by the doctors and will be used as a gold standard for the identification of seizures in order to train the algorithm.
This more complete base will be used to develop an algorithm previously developed from retrospective data.
- Conditions
- Epilepsy
- Being tested
- - EEG video recording or extension of an EEG video recording planned as part of the care - Wearing a connected heart rate and motion recording patch
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
- EEG video recording or extension of an EEG video recording planned as part of the care - Wearing a connected heart rate and motion recording patchOther
The study consists of creating a database to develop an algorithm using machine learning methods.
What is being measured
The primary outcome is the main question the study is designed to answer.
To build a training database under physiological conditions allowing the development of a detection algorithm for generalized and focal epileptic seizures in adults with epilepsy.
Movements will be measured with accelerometer.
Measured: Day12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start5 Jun 2023
- Primary completion24 Apr 2025
- Study completion24 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- 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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Collaborators
- La Teppe Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05637762
- Sponsor's protocol ID
- PLR_2022_11
- Acronym
- DetecTeppe
- Status last verified
- Feb 2025
- First submitted
- 8 Nov 2022
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Seizure Detection Algorithm Based on Heart Rate and Movement Analysis
- ClinicalTrials.gov ID
- NCT05637762
- Acronym / sponsor ID
- DetecTeppe / PLR_2022_11
- Conditions
- Epilepsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Collaborators
- La Teppe Institute
- Study start
- 5 Jun 2023 (actual)
- Primary completion
- 24 Apr 2025 (actual)
- Study completion
- 24 Apr 2025 (actual)
- First posted
- 5 Dec 2022 (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.
Epilepsy is the 3rd neurological pathology after migraines and dementia syndromes with a high estimate of nearly 600,000 people affected in France. The disease is characterized by the repetition of epileptic seizures on the one hand, but also by the cognitive, behavioral, psychological and social consequences of this condition, especially when the epileptic disease is not stabilized. Epileptic patients feel a great deal of stress due to the unpredictability of the occurrence of seizures.
Seizure detection is of great interest to bioinformatics researchers and to people with epilepsy and their caregivers. Recent advances in physiological sensor technologies and artificial intelligence have opened the possibility of developing systems capable of closely monitoring the frequency of epileptic seizures with a direct impact on therapeutic adaptations. This may eventually allow for seizure prediction and/or "seizure weather" (i.e., seizure forecasting) if there is a particular chronotype of seizure occurrence for a given individual.
Currently, few devices have a sufficient level of evidence regarding their effectiveness to be recommended. Those that seem to be the most advanced are those that allow the identification of hypermotor seizures, including tonic-clonic generalized seizures and tonic-clonic secondary generalized focal seizures, mostly occurring at night. The latter represent only a small part of epileptic seizures.
The objective of the present study is to build a real life database in order to develop a seizure detection algorithm.
The recorded data will be heart rate via ECG and movement data via 9 variables measured on 3 axes x, y, z, with 3 sensors: accelerometer, gyroscope, magnetometer. These data will be collected using a connected patch available on the market (CE marking).
At the same time, the patients will benefit from a long term video-EEG examination which will be annotated by the doctors and will be used as a gold standard for the identification of seizures in order to train the algorithm.
This more complete base will be used to develop an algorithm previously developed from retrospective data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The people with epilepsy will be recruited from among the patients/residents being followed for their epilepsy at the Institut La Teppe. Institut La Teppe is a medical and social institution that welcomes people suffering from epilepsy with cognitive deficiencies that can be severe.
Key inclusion criteria (4 listed)
- Person over 18 years of age - With drug-resistant epilepsy as defined by the International League Against Epilepsy
- Who has at least one recorded seizure with heart rate variation (i.e. tachycardia defined as an increase of 30 bpm or more than 50% over the interictal heart rate and/or bradycardia defined as a heart rate < 40 bpm or ictal asystole defined as an R-R interval greater than 3 seconds and usually lasting less than 60 seconds)
- Informed about the study and signed a consent to participate in the study (and their legal representative for patients under guardianship)
- Affiliated or beneficiary of a social insurance plan
Key exclusion criteria (6 listed)
- Pregnant or breastfeeding woman
- Persons with psychogenic non-epileptic seizures (PNES)
- Person with a history of severe heart disease (myocardial infarction, heart failure, rhythm disorder, severe hypertension)
- Persons with an implantable cardiac device (pacemaker, implantable defibrillator)
- Documented allergy to hydrogel and/or acrylate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| - EEG video recording or extension of an EEG video recording planned as part of the care - Wearing a connected heart rate and motion recording patchThe study consists of creating a database to develop an algorithm using machine learning methods. | Other | – |
Primary outcome
To build a training database under physiological conditions allowing the development of a detection algorithm for generalized and focal epileptic seizures in adults with epilepsy.
Time frame: Day12
Movements will be measured with accelerometer.
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 17 Dec 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site 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 6 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 17 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 1 site 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?
To build a training database under physiological conditions allowing the development of a detection algorithm for generalized and focal epileptic seizures in adults with epilepsy. (time frame: Day12). 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 17 Dec 2025.