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Studies suggest the existence of a pre-critical state preceding the onset of an epileptic seizure. Identifying these states from self-reported prodromal symptoms, combined with machine learning algorithms, could help anticipate seizures.
Around 65 million people worldwide, or 1% of the global population, suffer from epilepsy. It is the 3rd most common neurological pathology. Epilepsy is a chronic condition liable to generate spontaneous and repeated epileptic seizures, and it is estimated that around a third of patients are drug-resistant and will continue to have seizures despite appropriate anti-epileptic treatment. The onset of a seizure is a paroxysmal and unpredictable phenomenon - "a thunderclap in a serene sky" - which accounts for the handicap and social repercussions for patients.
The concept of a limited two-state model in epilepsy - i.e. intercritical/critical - has been challenged in recent decades. Ictogenesis could include a transitional state characterized by changes in cortical excitability that would pave the way for the onset of an epileptic seizure. This so-called pre-critical state is the scientific basis for seizure prediction models. If this state can be detected long enough before the onset of a seizure to detect a change in the brain's state, a seizure-stopping intervention (medication, biofeedback techniques, stimulation techniques, etc.), or at least safety measures, can be proposed.
While a deterministic approach has long been applied to predictive models - to predict the occurrence of the next crisis - a new strategy has more recently developed. Today's strategies are more realistic and adapted to non-linear dynamic systems. Indeed, probabilistic approaches from the meteorological sciences are increasingly being applied to crisis prediction models. The aim of crisis forecasting is to estimate the probability of a future crisis at any given time, whereas classical prediction algorithms aim to accurately predict the occurrence of a future crisis. In this way, we can identify a "pro"-critical state, i.e. a state at high risk of epileptic seizure.
Several studies have suggested the existence of a pre-critical period. However, identifying specific pre-critical biomarkers remains a major challenge. While information derived from EEG signals has long been favored, analysis of clinical symptoms has emerged more recently. Pre-critical clinical symptoms, otherwise known as "prodromes" or "prodromal symptoms", may precede the seizure by several hours. Some studies have also highlighted the value of integrating self-prediction - the patient's subjective assessment of the risk of an upcoming crisis - without anticipation models.
Previous work by the investigators has developed a classification algorithm capable of identifying a pre-critical state from the daily assessment of several prodromal symptoms. These results were obtained in a hospital setting, with good classification performance. This work was the subject of a European patent application (No. 20306548.7) on December 11, 2020 and an international patent application (No. PCT/EP2021/085146) on December 10, 2021: "A computer-implemented model for predicting occurrence of a seizure and training method thereof".
The main hypothesis of this study is that a machine learning algorithm based on the daily assessment of prodromal symptoms could identify seizure-prone states in patients with epilepsy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EPIDAY application | Experimental | Daily self-assessment via the Epiday application and collection of a seizure diary. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Seizure diary | Behavioral | collection of a seizure diary during 3 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the performance of daily probabilistic prediction of epileptic seizure risk using the EPIDAY mobile application, in patients with focal epilepsy, under real-life conditions. | number of patients with a Brier score < 0.3 and a Brier Skill Score > 0 | 28 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Louis COUSYN, MD | Contact | 0142161801 | +33 | louismarc.cousyn@aphp.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Pitié-Salpêtrière, AP-HP | Paris | 75013 | France |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Daily self-assessment via the Epiday application and collection of a seizure diary.
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| Questionnaries |
| Behavioral |
Daily self-assessment via the Epiday application during 3 months |
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