NCT06320639 · RECRUITING
DRIVing Simulator and People With NeuroCognitive Disorders
This study uses a driving simulator to measure how well people with neurocognitive disorders — such as mild cognitive impairment or dementia — can drive and, crucially, how accurately they judge their own driving ability. Researchers will compare simulator performance and self-awareness scores between people with NCDs and a healthy control group. There is no phase designation; this is an observational, exploratory study with no drug or treatment involved.
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
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2024-03-20