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NCT07809828

Driving Performance in Parkinson's Disease and Multiple Sclerosis Using a Driving Simulator

Sponsor: University Hospital Olomouc

View on ClinicalTrials.gov

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.

Official title: Simulator-Based Assessment of Driving Performance in Patients With Parkinson's Disease and Multiple Sclerosis

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2026-11-01

Completion Date

2027-12-31

Last Updated

2026-09-09

Healthy Volunteers

Yes

Conditions

Parkinson Multiple Sclerosis

Interventions

OTHER

Standardized Driving Simulator Assessment

Participants undergo a standardized driving simulator assessment consisting of an adaptation period followed by a structured simulated driving scenario. The scenario includes baseline driving, lane keeping and lane changes, urban driving, intersections, hazard events, roundabouts, motorway entry, vehicle following, multilane driving, and reduced-visibility conditions. Simulator telemetry records vehicle speed, steering and pedal inputs, lateral position, trajectory, following distance, time-to-collision, reaction times, and other driving-performance parameters. Depending on the validated technical configuration, synchronized video, eye-tracking, physiological, and audio data may also be collected. The assessment is performed for research purposes and is not a therapeutic intervention or a stand-alone diagnostic or fitness-to-drive test.

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.