Neurocognitive DisordersDRIVS-NCDNCT06320639
DRIVing Simulator and People With NeuroCognitive Disorders
An observational study of Neurocognitive Disorders, run by University Gustave Eiffel at 1 site in France.
Trial summary
The ageing of the population is leading to an increasing number of older drivers on the roads. At the same time, the proportion of older people with pathological ageing and neurocognitive disorders (NCD) is increasing. Read more about this study
- Who is it for?
- Ages 50 to 95 years
- Conditions the study is for
- Neurocognitive Disorders
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 3 Oct 2023to 10 Oct 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 50 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diagnosed with minor or major Neurocognitive Disorders according to the Diagnostic and Statistical Manual of Mental Disorders-V (DSM-V) and recruited from the daycare hospital
Who may be able to join
- Diagnosed with Neurocognitive Disorders according to the Diagnostic and Statistical Manual of Mental Disorders-V (DSM-V)
- Normal or corrected vision
- B licence holder with 3+ years driving experience
- Active drivers or drivers who stopped driving less than 2 months ago (time between the medical consultation and the day in the day care hospital)
- For participants able to give consent:
- Written informed consent to participate in the study
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- Informed consent of the participant in the presence of his/her curator.
- For participants who are not able to receive information and to give consent:
- Written informed consent of the legal representative (tutor) for participants under tutelage.
- Signature of a relative (family member and/or trusted person) of the participant
- The participant has to be affiliated to a social security scheme.
Who cannot join
- History of epilepsy
- People with vestibular disorders, motion sickness or migraines
- Psychiatric history (e.g. schizophrenia)
- Non-stabilized use of antidepressants and/or anxiolytics (started or modified within the last 3 months)
- History of alcoholism
- Use of anti-epileptics
- Osteo-articular pathologies compromising walking
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital des Charpennes
Villeurbanne, 69100
Marion Giroux, PhD, 0472432372, marion.giroux@chu-lyon.fr
About this study
Official title: Driving Simulator and People With Neurocognitive Disorders
The ageing of the population is leading to an increasing number of older drivers on the roads. At the same time, the proportion of older people with pathological ageing and neurocognitive disorders (NCD) is increasing. In terms of road safety, this raises the question of whether these drivers should continue to drive or not. People with NCDs may not be aware of the presence, extent and progression of their cognitive impairment and the impact it can have on daily life, including driving.
Despite their loss of autonomy and medical advice, 22% of people with major NCD continue to drive. In addition, the presence of minor NCD also puts people at a higher risk of road accidents.
Read more
However, several studies demonstrated that an NCD does not lead to a systematic and immediate impairment of driving ability and abruptly stopping driving leads to health problems, such as the risk of depression and greatly reduces quality of life.
It is therefore relevant to focus research on driving with people with NCD in order to have a reliable indicator of the person's abilities and the impact of their cognitive impairment on driving activity. The proposed study seeks to meet this need by studying the performance of people with NCD on a driving station (mini-simulator) while assessing their ability to evaluate their performance.
To achieve this goal, people with NCDs will perform tasks on a driving simulator. In addition, after each task on the driving simulator, they will answer questions about how they evaluate their own driving. Two assessors will observe the participants' driving and will estimate their driving performance. By comparing the driver's self-assessment with the assessors' assessment, an "awareness score of driving ability" will be calculated to determine whether the driver correctly assessed his or her performance.
Another project already underway aims to collect similar data from people without a diagnosis of NCDs (control group).
The principal objective of the present study is to compare the driving performance in a simulator and the awareness of driving ability of people with NCDs with those of a control group. Secondary objectives are :
- to measure driving performance in a simulator and awareness of driving abilities (i.e. self-assessment skills) of people with NCDs.
- to analyse driving performance and awareness of driving abilities according to the diagnosis and severity of the disorder (i.e. minor or major neurocognitive disorders).
- to establish a methodology to identify a driver at risk of dangerous driving.
It is mainly an exploratory study however some hypotheses can be made :
- The driving performance and awareness of driving skills of people with NCDs are poorer compared to those of older, control individuals.
- Individuals' driving performance and awareness of driving ability are lower in the presence of major NCDs compared to minor NCDs.
- Conditions
- Neurocognitive Disorders
- Keywords
- Alzheimer's Disease, Vascular encephalopathy, Parkinson's Disease
- Medical subject headings
- Neurocognitive Disorders, Alzheimer Disease, Parkinson Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Awareness score of driving ability
After each task on the driving simulator, participants answer questions about what they think of their driving performance. Two experimenters write their observations about the participant's performance. Answers are coded in a way that a greater driving performance lead to a greater score.
The Awareness score is computed by subtracting the score given by the participant to the average of the scores given by the experimenters. The further away from zero the score is, the less aware the participants will be of their abilities. Zero will indicate a perfect assessment of one's abilities.
Measured: Up to 2 hours, from the inclusion until the end of the experiment (2 hours later)
Driving performance variables measured by the driving simulator
For each driving task, the driving variables of interest from the driving simulator will be collected: total braking response time, average speed and lateral lane position for the keeping lane task; distance between vehicles for the car-tracking task; reaction time to unexpected events for the rural and urban driving tasks.
Measured: Up to 2 hours, from the inclusion until the end of the experiment (2 hours later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start3 Oct 2023
- Primary completion10 Oct 2026 (estimated)
- Study completion10 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neurocognitive DisordersStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Gustave Eiffel
- Sponsor type
- University, hospital or other
- Collaborators
- Hospices Civils de Lyon
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06320639
- Sponsor's protocol ID
- UGustaveEiffel
- Acronym
- DRIVS-NCD
- Status last verified
- Mar 2024
- First submitted
- 19 Feb 2024
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Delphin-Combe F, Coste MH, Bachelet R, Llorens M, Gentil C, Giroux M, Paire-Ficout L, Ranchet M, Krolak-Salmon P. An innovative therapeutic educational program to support older drivers with cognitive disorders: Description of a randomized controlled trial study protocol. Front Neurol. 2022 Jul 18;13:901100. doi: 10.3389/fneur.2022.901100. eCollection 2022.
PubMed 35923824
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Driving Simulator and People With Neurocognitive Disorders
- ClinicalTrials.gov ID
- NCT06320639
- Acronym / sponsor ID
- DRIVS-NCD / UGustaveEiffel
- Conditions
- Neurocognitive Disorders
- Keywords
- Alzheimer's Disease, Vascular encephalopathy, Parkinson's Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Gustave EiffelUniversity, hospital or other
- Collaborators
- Hospices Civils de Lyon
- Study start
- 3 Oct 2023 (actual)
- Primary completion
- 10 Oct 2026 (estimated)
- Study completion
- 10 Oct 2026 (estimated)
- First posted
- 20 Mar 2024 (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.
The ageing of the population is leading to an increasing number of older drivers on the roads. At the same time, the proportion of older people with pathological ageing and neurocognitive disorders (NCD) is increasing. In terms of road safety, this raises the question of whether these drivers should continue to drive or not. People with NCDs may not be aware of the presence, extent and progression of their cognitive impairment and the impact it can have on daily life, including driving.
Despite their loss of autonomy and medical advice, 22% of people with major NCD continue to drive. In addition, the presence of minor NCD also puts people at a higher risk of road accidents.
However, several studies demonstrated that an NCD does not lead to a systematic and immediate impairment of driving ability and abruptly stopping driving leads to health problems, such as the risk of depression and greatly reduces quality of life.
It is therefore relevant to focus research on driving with people with NCD in order to have a reliable indicator of the person's abilities and the impact of their cognitive impairment on driving activity. The proposed study seeks to meet this need by studying the performance of people with NCD on a driving station (mini-simulator) while assessing their ability to evaluate their performance.
To achieve this goal, people with NCDs will perform tasks on a driving simulator. In addition, after each task on the driving simulator, they will answer questions about how they evaluate their own driving. Two assessors will observe the participants' driving and will estimate their driving performance. By comparing the driver's self-assessment with the assessors' assessment, an "awareness score of driving ability" will be calculated to determine whether the driver correctly assessed his or her performance.
Another project already underway aims to collect similar data from people without a diagnosis of NCDs (control group).
The principal objective of the present study is to compare the driving performance in a simulator and the awareness of driving ability of people with NCDs with those of a control group. Secondary objectives are :
- to measure driving performance in a simulator and awareness of driving abilities (i.e. self-assessment skills) of people with NCDs.
- to analyse driving performance and awareness of driving abilities according to the diagnosis and severity of the disorder (i.e. minor or major neurocognitive disorders).
- to establish a methodology to identify a driver at risk of dangerous driving.
It is mainly an exploratory study however some hypotheses can be made :
- The driving performance and awareness of driving skills of people with NCDs are poorer compared to those of older, control individuals.
- Individuals' driving performance and awareness of driving ability are lower in the presence of major NCDs compared to minor NCDs.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 50 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diagnosed with minor or major Neurocognitive Disorders according to the Diagnostic and Statistical Manual of Mental Disorders-V (DSM-V) and recruited from the daycare hospital
Key inclusion criteria (11 listed)
- Diagnosed with Neurocognitive Disorders according to the Diagnostic and Statistical Manual of Mental Disorders-V (DSM-V)
- Normal or corrected vision
- B licence holder with 3+ years driving experience
- Active drivers or drivers who stopped driving less than 2 months ago (time between the medical consultation and the day in the day care hospital)
- For participants able to give consent:
Key exclusion criteria (7 listed)
- History of epilepsy
- People with vestibular disorders, motion sickness or migraines
- Psychiatric history (e.g. schizophrenia)
- Non-stabilized use of antidepressants and/or anxiolytics (started or modified within the last 3 months)
- History of alcoholism
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
Awareness score of driving ability
Time frame: Up to 2 hours, from the inclusion until the end of the experiment (2 hours later)
After each task on the driving simulator, participants answer questions about what they think of their driving performance. Two experimenters write their observations about the participant's performance. Answers are coded in a way that a greater driving performance lead to a greater score. The Awareness score is computed by subtracting the score given by the participant to the average of the scores given by the experimenters. The further away from zero the score is, the less aware the participants will be of their abilities. Zero will indicate a perfect assessment of one's abilities.
Driving performance variables measured by the driving simulator
Time frame: Up to 2 hours, from the inclusion until the end of the experiment (2 hours later)
For each driving task, the driving variables of interest from the driving simulator will be collected: total braking response time, average speed and lateral lane position for the keeping lane task; distance between vehicles for the car-tracking task; reaction time to unexpected events for the rural and urban driving tasks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Results publication: PubMed 35923824Delphin-Combe F, Coste MH, Bachelet R, Llorens M, Gentil C, Giroux M, Paire-Ficout L, Ranchet M, Krolak-Salmon P. An innovative therapeutic educational program to support older drivers with cognitive disorders: Description of a randomized controlled trial study protocol. Front Neurol. 2022 Jul 18;13:901100. doi: 10.3389/fneur.2022.901100. eCollection 2022.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
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 Neurocognitive Disorders, run by University Gustave Eiffel 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 11 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 20 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maud Ranchet, PhD (0472142599, maud.ranchet@univ-eiffel.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Awareness score of driving ability (time frame: Up to 2 hours, from the inclusion until the end of the experiment (2 hours later)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06320639, which also lists 1 linked publication.
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 20 Mar 2024.