EpilepsyEPICONCT07026591
Epilepsy and Driving
An observational study of Epilepsy, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Epilepsy
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 6 Nov 2025to Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Epileptic patients and healthy volunteers
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Institut La Teppe
Tain-l'Hermitage, 26600
Cécile Sabourdy, Dr, +33475075959, cecile.sabourdy@teppe.org
About this study
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
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speed
Mean speed during the simulated driving task
Measured: Day 0
Phasic alertness
Phasic alertness on neuropsychological test (TAP)
Measured: Day 0
Lane position
Mean lane position during the simulated driving task
Measured: Day 0
Braking time
Mean braking time during the simulated driving task
Measured: Day 0
Information processing time
Mean information processing time during the simulated driving task
Measured: Day 0
Sustained attention
Sustained attention on neuropsychological test (TAP)
Measured: Day 0
Divided attention
Divided attention on neuropsychological test (TAP)
Measured: Day 0
Visual scanning
Visual scanning on neuropsychological test (TAP)
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start6 Nov 2025
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07026591
- Sponsor's protocol ID
- CSY_2025_4
- Acronym
- EPICO
- Status last verified
- Oct 2026
- First submitted
- 27 May 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epilepsy and Driving
- ClinicalTrials.gov ID
- NCT07026591
- Acronym / sponsor ID
- EPICO / CSY_2025_4
- Conditions
- Epilepsy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 6 Nov 2025 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 18 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Epileptic patients and healthy volunteers
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Speed
Time frame: Day 0
Mean speed during the simulated driving task
Phasic alertness
Time frame: Day 0
Phasic alertness on neuropsychological test (TAP)
Lane position
Time frame: Day 0
Mean lane position during the simulated driving task
Braking time
Time frame: Day 0
Mean braking time during the simulated driving task
Information processing time
Time frame: Day 0
Mean information processing time during the simulated driving task
Sustained attention
Time frame: Day 0
Sustained attention on neuropsychological test (TAP)
Divided attention
Time frame: Day 0
Divided attention on neuropsychological test (TAP)
Visual scanning
Time frame: Day 0
Visual scanning on neuropsychological test (TAP)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amelie Yavchitz (+33 1 48 03 64 54, ayavchitz@for.paris), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speed (time frame: Day 0). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.