Informations générales (source: ClinicalTrials.gov)
Development of a Seizure Detection Algorithm Based on Heart Rate and Movement Analysis (DetecTeppe)
Observational
Fondation Ophtalmologique Adolphe de Rothschild (Voir sur ClinicalTrials)
juin 2023
juin 2025
05 avril 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL FONDATION A. DE ROTHSCHILD | Patrick LATOUR | 31/01/2025 08:40:57 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Institut La Teppe - 26600 - Tain-l'Hermitage - France | Patrick Latour, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- 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
- 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
- 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