Driving Performance in Parkinson's Disease and Multiple Sclerosis Using a Driving Simulator
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorUniversity Hospital Olomouc
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
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.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Standardized Driving Simulator Assessment
Other interventionParticipants 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.
Treatment groups
100 Participants
are divided into 3 treatment groupsGroup A: Healthy control1 intervention
Group B: Multiple sclerosis1 intervention
Group C: Parkinson's disease1 intervention
Trial outcomes
Primary outcomes
1
Standard Deviation of Lateral Position During Lane-Keeping
Standard deviation of the lateral position of the participant's vehicle relative to the center of the driving lane during predefined lane-maintenance segments. The measure will be derived from continuous simulator telemetry and expressed in meters. Higher values indicate greater variability in lateral vehicle control.
Time frame
During the single standardized driving simulator assessment, approximately 30-60 minutes2
Brake Reaction Time to Standardized Driving Hazards
Time from the onset of a predefined hazardous traffic event to initiation of braking by the participant. Standardized hazards may include sudden braking of a lead vehicle, a pedestrian entering the roadway, or a vehicle entering from a side road. Reaction time will be derived from synchronized simulator event and pedal telemetry and expressed in seconds. Longer reaction times indicate a slower braking response.
Time frame
During standardized hazard events within the single driving simulator assessment, approximately 30-60 minutes3
Mean Time Headway During Vehicle-Following
Mean time interval between the participant's vehicle and a predefined lead vehicle during standardized car-following segments. Time headway will be calculated from simulator telemetry and expressed in seconds. Lower values indicate shorter following distances and potentially reduced safety margins.
Time frame
During predefined car-following segments within the single driving simulator assessment, approximately 30-60 minutesSecondary outcomes
1
Standard Deviation of Vehicle Speed
Standard deviation of vehicle speed during predefined driving segments with a specified speed limit. The measure will be expressed in kilometers per hour and will characterize the participant's ability to maintain stable speed.
Time frame
During predefined speed-maintenance segments within the single driving simulator assessment, approximately 30-60 minutes2
Gas-to-Brake Transition Time
Time interval between release of the accelerator pedal and initiation of brake-pedal depression during predefined events requiring braking. The measure will be derived from simulator pedal telemetry and expressed in seconds. Longer intervals indicate slower transition between accelerator and brake control.
Time frame
During predefined braking events within the single driving simulator assessment, approximately 30-60 minutes3
Minimum Time-to-Collision During Critical Traffic Events
Minimum estimated time remaining before collision with another road user or vehicle during predefined critical traffic situations, assuming the instantaneous relative trajectories are maintained. The measure will be calculated from simulator telemetry and expressed in seconds. Lower values indicate a smaller safety margin.
Time frame
During predefined critical traffic events within the single driving simulator assessment, approximately 30-60 minutes4
Number of Unsafe or Unsuccessful Lane Changes
Number of predefined lane-change maneuvers that are not completed successfully or are performed under unsafe conditions according to prespecified simulator criteria, including inadequate gap selection, conflict with surrounding traffic, or failure to complete the instructed maneuver.
Time frame
During predefined lane-change scenarios within the single driving simulator assessment, approximately 30-60 minutesOther outcomes
1
Visual Scanning Behavior During Simulated Driving
Eye-tracking-derived characteristics of visual scanning during driving, including fixation and gaze behavior toward traffic-relevant areas and, where technically valid, observation of mirrors and blind spots. Specific eye-tracking metrics will be calculated only for recordings meeting predefined technical quality requirements.
Time frame
During the single standardized driving simulator assessment, approximately 30-60 minutes2
Mirror and Blind-Spot Observation During Driving Maneuvers
Frequency and timing of mirror and blind-spot checks before predefined lane changes or turning maneuvers, derived from validated eye-tracking and/or video recordings. The measure will characterize visual exploration of the surrounding traffic environment before a maneuver
Time frame
During predefined lane-change and turning maneuvers within the single driving simulator assessment, approximately 30-60 minutes3
Heart Rate During Simulated Driving
Heart rate recorded using a chest-worn physiological sensor during the simulator assessment. Physiological data will be analyzed only when technically valid recordings are available and may be examined in relation to predefined driving events and task demands.
Time frame
During the single standardized driving simulator assessment, approximately 30-60 minutes4
Completion of the Standardized Driving Simulator Assessment
Proportion of participants who complete the planned simulator assessment without premature termination. Reasons for discontinuation, including simulator sickness, dizziness, fatigue, anxiety, participant request, clinical decision, or technical failure, will be documented.
Time frame
From start of simulator adaptation to completion or premature termination of the simulator session, approximately 30-60 minutesLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital Olomouc
Lead sponsor
Digiteq Automotive
Collaborator
Source ClinicalTrials.gov
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