Simulator-Based assessment of driving performance in patients with Parkinson's disease and multiple sclerosis

NCT ID NCT07809828

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First seen Sep 09, 2026 · Last updated Sep 09, 2026

Summary

This prospective observational study investigates whether driving performance measured in a standardized driving simulator differs between people with Parkinson's disease, people with multiple sclerosis, and healthy drivers. Participants will complete a standardized simulated driving assessment designed to evaluate abilities relevant to safe driving, including lane keeping, speed control, vehicle following, responses to hazards, lane changes, navigation, and compliance with traffic rules. Driving simulator measures will also be examined in relation to clinical characteristics and results from previously performed cognitive, motor, and psychodiagnostic assessments in the patient groups. The main research question is whether a driving simulator can detect measurable patterns of driving performance associated with Parkinson's disease or multiple sclerosis when compared with healthy drivers. The study hypothesis is that participants with these neurological conditions will show differences in selected driving performance measures and that some of these differences will be associated with the clinical severity and functional manifestations of their disease. The study will also explore whether additional information from eye tracking, video-based measurements, and physiological signals can improve the characterization of driving performance. The results are intended to support the development of objective methods for studying driving-related functions in neurological disease. Simulator results will be used for research purposes and will not by themselves determine an individual's medical fitness to drive.

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Study facts

What this study's own registry entry says, in plain language.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The clinical study population will be drawn from participants previously assessed within the OP-JAK (NCT07360886) research framework at the participating neurological center. These participants have established diagnoses of Parkinson's disease or multiple sclerosis and have previously completed relevant psychodiagnostic and screening assessments. The healthy control group will be recruited separately by the technology partner from the general community and assessed using the same standardized driving simulator protocol under comparable technical and organizational conditions. The study therefore includes two clinically characterized neurological cohorts and one non-clinical community-based control cohort.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age 18 to 85 years. * Ability to understand study instructions and provide written informed consent. * Valid driving license for passenger vehicles (Category B or equivalent). * Active non-professional driving of a motor vehicle. * Ability to understand the instructions and complete the standardized driving simulator assessment. For participants with multiple sclerosis: * Confirmed diagnosis of multiple sclerosis according to applicable diagnostic criteria. * Expanded Disability Status Scale (EDSS) score less than 6.5. * Clinically stable disease at the time of simulator assessment. * At least 6 weeks since the most recent multiple sclerosis relapse and any corticosteroid treatment for relapse. * Previous completion of the psychodiagnostic and screening assessment used in the preceding OP-JAK research framework (NCT07360886) within 6 months before simulator testing, provided that no clinically relevant deterioration has occurred. * Completion of the required neurological, ophthalmological, visual-field, and audiometric assessments before or on the day of simulator testing, as specified by the study protocol. For participants with Parkinson's disease: * Confirmed diagnosis of idiopathic Parkinson's disease. * Hoehn and Yahr less than stage IV in the ON-medication state. * Clinically stable condition at the time of simulator assessment. * Ability to undergo simulator testing during the best practically achievable ON-medication state. * Previous completion of the psychodiagnostic and screening assessment used in the preceding OP-JAK research framework within 6 months before simulator testing, provided that no clinically relevant deterioration has occurred. * Completion of the required neurological, ophthalmological, visual-field, and audiometric assessments before or on the day of simulator testing, as specified by the study protocol. For healthy control participants: * No known neurological disorder expected to substantially affect driving performance. * Self-reported current health status compatible with safe completion of the driving simulator assessment. * Visual and auditory function, with usual correction if applicable, sufficient to safely and validly complete the simulator assessment. Exclusion Criteria: * Acute medical or neurological deterioration that would prevent safe or valid completion of the driving simulator assessment. * Current intoxication with alcohol or other psychoactive substances. * Marked sleep deprivation, excessive fatigue, or another temporary condition that, in the judgment of the responsible study personnel, would substantially impair the ability to complete testing safely and validly. * Severe simulator sickness or current vestibular symptoms that prevent completion of simulator testing. * Clinically significant uncorrected visual or auditory impairment that prevents valid completion of the simulator assessment. Inability to understand study instructions or safely operate the driving simulator. \- Withdrawal of consent or refusal of data recording required for the study when no technically valid alternative method is available. Additional exclusion criteria for participants with multiple sclerosis: * Current multiple sclerosis relapse. * Less than 30 days since the most recent relapse or corticosteroid treatment for relapse. * EDSS score \> 6.5. Additional exclusion criteria for participants with Parkinson's disease: * Atypical parkinsonian syndrome. * Hoehn and Yahr stage \> 4 in the ON-medication state. * Deep brain stimulation in the main Parkinson's disease cohort. * Clinical condition preventing testing during a sufficiently stable ON-medication period. Additional exclusion criteria for healthy control participants: * Self-reported neurological disease or other health condition expected to substantially influence cognitive, sensory, or motor functions relevant to driving. * Current psychiatric or medical condition that would prevent safe or valid completion of the simulator assessment. * Current use of substances or medications producing an acute level of impairment incompatible with safe simulator testing.

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Conditions

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