Epilepsy and Driving

NCT ID: NCT07026591

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-11-06

Study Completion Date

2027-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Epilepsy can lead to cognitive impairments, particularly in attention, which may affect daily activities such as driving. Driving plays a key role in maintaining autonomy and is essential for the social and professional integration of people with epilepsy. Therefore, assessing fitness to drive is a major issue for individuals with epilepsy.

French legislation governing driving for people with epilepsy clearly outlines the periods during which a person is not permitted to drive. However, the means or methods for evaluating driving fitness in these individuals are not well defined. Currently, assessment is based more on a medical consultation than on a comprehensive evaluation of driving ability.

Using a driving simulator in combination with an EEG could be a valuable approach to better assess the impact of epilepsy-related cognitive impairments on driving performance.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Epilepsy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

epilectic patients

Individuals with epilepsy who drive at least once a month

No interventions assigned to this group

healthy volunteers

healthy volunteers driving at leat once a month, matched to epileptic patients on age (+-/ 5 years), sex and driving experience (+/-3 years)

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Aged between 18 and 65 years
* Holder of a category B driving license
* Active driver: drives at least once a month
* No medical condition contraindicating driving, except for epilepsy
* Provides explicit consent to participate in the study
* Affiliated with or a beneficiary of a social security scheme

Exclusion Criteria

* Subject to legal protection (guardianship and curatorship are accepted for individuals with epilepsy, as this population represents a significant proportion of our institution's patients)
* Pregnant or breastfeeding women
* Known cybersickness (virtual reality or simulator sickness)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Institut La Teppe

Tain-l'Hermitage, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Amelie Yavchitz

Role: CONTACT

+33 1 48 03 64 54

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Cécile Sabourdy, Dr

Role: primary

+33475075959

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CSY_2025_4

Identifier Type: -

Identifier Source: org_study_id