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

NCT07068919 | Not Yet Recruiting

• 1 other identifier: APHP251044
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy

Keywords

epilepsy; Neurology; algorithm

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

EPIDAY application

EXPERIMENTAL

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

Behavioral: Seizure diary; Behavioral: Questionnaries

Interventions

Seizure diary BEHAVIORAL

collection of a seizure diary during 3 months

EPIDAY application

Questionnaries BEHAVIORAL

Daily self-assessment via the Epiday application during 3 months

EPIDAY application

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• Pregnant or breastfeeding woman
• Patient under guardianship, curatorship, deprived of liberty

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Pitié-Salpêtrière, AP-HP

Paris, 75013, France

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Louis COUSYN, MD

CONTACT

0142161801; louismarc.cousyn@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: July 16, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)