Epilepsy and Driving

NCT07026591 | Recruiting

• 1 other identifier: CSY_2025_4
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (8)

• Speed

  Mean speed during the simulated driving task

  Day 0

• Phasic alertness

  Phasic alertness on neuropsychological test (TAP)

  Day 0

• Lane position

  Mean lane position during the simulated driving task

  Day 0

• Braking time

  Mean braking time during the simulated driving task

  Day 0

• Information processing time

  Mean information processing time during the simulated driving task

  Day 0

• Sustained attention

  Sustained attention on neuropsychological test (TAP)

  Day 0

• Divided attention

  Divided attention on neuropsychological test (TAP)

  Day 0

• Visual scanning

  Visual scanning on neuropsychological test (TAP)

  Day 0

Study Arms (2)

epilectic patients

Individuals with epilepsy who drive at least once a month

healthy volunteers

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Epileptic patients and healthy volunteers

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Institut La Teppe

Tain-l'Hermitage, 26600, France

RECRUITING

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Amelie Yavchitz

CONTACT

+33 1 48 03 64 54; ayavchitz@for.paris

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: June 18, 2025
• Study Start: November 6, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: December 17, 2025

Record last verified: 2025-12

Locations

FR (1)