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Clinical Trials in France / NCT07068919
Starting soon Not applicable

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

NCT07068919 · tracked via the Priya Life Science France tracker
Sponsor
Assistance Publique - Hôpitaux de Paris
Phase
Not applicable
Started
2025-10
Last updated
2025-09-15

Condition(s) studied

Epilepsy

Investigational drug(s) / intervention(s)

Seizure diaryQuestionnaries

Seizure diary: collection of a seizure diary during 3 months

Questionnaries: Daily self-assessment via the Epiday application during 3 months

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
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

Primary outcome measure(s)

  • 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 months
    number of patients with a Brier score \< 0.3 and a Brier Skill Score \> 0

Trial sites (1)

FacilityCityRegionStatus
Hôpital Pitié-Salpêtrière, AP-HP Paris France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07068919 on ClinicalTrials.gov ↗ ← All trials in France