Clinical trial NCT06320639: DRIVing Simulator and People With NeuroCognitive Disorders
Official title: Driving Simulator and People With Neurocognitive Disorders
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neurocognitive Disorders
Keywords: Alzheimer's Disease
Vascular encephalopathy
Parkinson's Disease
Lead sponsor: University Gustave Eiffel
Sponsor class: OTHER
Collaborators: name: Hospices Civils de Lyon
First posted: 2024-03-20
Enrollment: 150
Sex: ALL
Minimum age (years): 50
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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. 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 :

1. to measure driving performance in a simulator and awareness of driving abilities (i.e. self-assessment skills) of people with NCDs.
2. 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).
3. 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.


Eligibility criteria: Inclusion Criteria:

* 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
  * 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Awareness score of driving ability
timeFrame: Up to 2 hours, from the inclusion until the end of the experiment (2 hours later)
measure: Driving performance variables measured by the driving simulator
timeFrame: Up to 2 hours, from the inclusion until the end of the experiment (2 hours later)
Secondary outcomes:
Other outcomes:
Locations:
city: Villeurbanne
country: France
facility: Hôpital des Charpennes
Study officials:
References:
citation: 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.