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Prospective Evaluation of Probabilistic Predictions of Epileptic Seizure Risk Using the EPIDAY Tool

Prospective Evaluation of Probabilistic Predictions of Epileptic Seizure Risk Using the EPIDAY Tool

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07068919
Acronym
EPIDAY
Enrollment
50
Registered
2025-07-16
Start date
2025-10-31
Completion date
2028-01-31
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

Keywords

epilepsy, Neurology, algorithm

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALSeizure diary

collection of a seizure diary during 3 months

BEHAVIORALQuestionnaries

Daily self-assessment via the Epiday application during 3 months

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Intervention model description

Daily self-assessment via the Epiday application and collection of a seizure diary.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Age between 18 and 65 * Focal epilepsy diagnosed for at least 18 months * Brain imaging as part of the etiological work-up for epilepsy showing no progressive cause * EEG compatible with the diagnosis of epilepsy within the last 10 years * At least 2 non-contiguous days of epileptic seizures per month, according to the patient * Ability of the patient to understand and use a mobile application on the personal smartphone * Free, informed and signed consent * Affiliation with a social security scheme (excluding AME)

Exclusion criteria

* Suspicion or diagnosis of other types of associated malaise: functional dissociative seizures, syncope or other malaise of non-neurological origin * Assessment of seizure frequency deemed unreliable by the investigator (eg. due to cognitive impairment) * Inability to describe seizures accurately * Presence of more than 15 days with seizures per month * Participation in other interventional research or exclusion period not expired * Pregnant or breastfeeding woman * Patient under guardianship, curatorship, deprived of liberty

Design outcomes

Primary

MeasureTime frameDescription
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.28 monthsnumber of patients with a Brier score \< 0.3 and a Brier Skill Score \> 0

Countries

France

Contacts

Primary ContactLouis COUSYN, MD
louismarc.cousyn@aphp.fr0142161801

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026