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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Multiple Sclerosis; Parkinson
• Intervention / Treatment: Other: Standardized Driving Simulator Assessment

Detailed Description

NeuroSimDrive is a prospective observational comparative driving-simulator study designed to characterize driving performance in people with Parkinson's disease and multiple sclerosis using a standardized simulator-based assessment. The study integrates simulator-derived driving data with clinical and functional information already available from previous assessments performed in the participating patient cohorts.

The clinical groups consist of participants with established neurological diagnoses who previously completed psychodiagnostic and screening assessments within an earlier research framework. These pre-existing data include measures of cognitive, attentional, motor, and other functions potentially relevant to driving performance. The simulator study does not use these previous test results as a basis for exclusion; instead, they will be incorporated as explanatory variables when interpreting simulator performance.

A central methodological feature of the study is standardization of the participant's clinical condition at the time of simulator testing. All patients undergo neurological assessment on the day of the simulator session to verify clinical stability and to document factors that could influence driving performance. In participants with multiple sclerosis, disability is characterized using the Expanded Disability Status Scale (EDSS), including relevant functional system scores. In participants with Parkinson's disease, motor status is characterized using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS III) and Hoehn and Yahr staging. Parkinson's disease participants are assessed during the best practically achievable ON-medication state, with timing of dopaminergic medication and simulator testing documented to improve interpretability of the driving data.

Visual and auditory function are assessed before simulator testing because sensory impairment may affect the validity and interpretation of driving performance. Specialized ophthalmologic assessment, including visual field testing, and audiometric assessment are therefore incorporated into the clinical characterization of the patient groups.

Before the simulator session patients are also screened by Montreal Cognitive Assessment.

The simulator session includes standardized instructions, an adaptation period, and a structured driving scenario. The adaptation period allows participants to become familiar with the simulator controls and virtual environment and provides an opportunity to assess tolerance of the simulation before the evaluated part of the session begins. The expected duration of the simulator component, including instructions and adaptation, is approximately 30 to 60 minutes.

The driving scenario is composed of predefined modules representing common and safety-relevant driving demands. These include baseline driving, lane-changing situations, urban driving, intersections, hazard events, roundabouts, motorway entry, vehicle following, multilane driving, reduced-visibility conditions, and a short repeated module. The same simulator configuration, scenario structure, instructions, and technical conditions are intended to be used across the study groups to maximize comparability.

The simulator continuously records vehicle-control and driving-behavior data, including steering input, pedal use, vehicle speed, lateral position, vehicle trajectory, distance and time relationships to surrounding traffic, and event-related responses. The technical infrastructure may additionally include a camera system, eye tracking, a chest-worn physiological sensor, and a microphone, depending on the final validated study configuration. These additional systems are intended to provide complementary information about visual attention, head and eye movements, selected motor manifestations, physiological responses, and verbal reactions where applicable.

Simulator and sensor data will be time-synchronized and linked to predefined driving segments and events. This allows driving behavior to be examined in relation to the specific demands of each scenario rather than only as an overall session average. Technical validity, completeness of the recording, reasons for interruption, and relevant clinical conditions at the time of testing will be documented for each simulator session.

Healthy control participants are assessed by the technology partner using the same simulator and the same standardized driving scenario under comparable technical and organizational conditions. The control group provides a reference population for interpretation of simulator-derived driving patterns observed in the neurological cohorts.

The study is exploratory and hypothesis-generating in nature. Analyses will focus on group-level differences in simulator-derived driving behavior and on associations between driving performance and clinical, cognitive, motor, and functional characteristics. Additional exploratory analyses may assess whether multimodal data from video, eye tracking, or physiological monitoring provide information beyond conventional simulator telemetry.

Because of the pilot sample size, interpretation will emphasize effect sizes, confidence intervals, feasibility, tolerability, and the consistency of observed performance patterns rather than the establishment of definitive diagnostic thresholds. The study is not designed to provide an individual medical or legal determination of fitness to drive. Simulator findings will be interpreted as research data and not as stand-alone decisions regarding a participant's driving license or medical driving eligibility.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Ladislav Stanke; Phone Number: +420 588 443 713; Email: ladislav.stanke@fnol.cz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy control; Healthy adult drivers without a known neurological disorder that would be expected to affect driving performance. Participants will undergo the same standardized driving simulator assessment as the clinical cohorts under comparable technical and organizational conditions. Simulator-derived driving data will serve as the reference for comparison with participants with multiple sclerosis and Parkinson's disease. Healthy controls will be recruited and assessed by the technology partner and will not undergo the detailed clinical neurological assessment used for the patient cohorts.	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.
Multiple sclerosis; Participants with a confirmed diagnosis of multiple sclerosis who will undergo standardized driving simulator assessment. Clinical status will be characterized at the time of simulator testing, including neurological examination and assessment of disability using the Expanded Disability Status Scale (EDSS). Simulator-derived driving performance will be evaluated in relation to clinical and previously obtained functional measures and compared with both healthy controls and participants with Parkinson's disease.	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.
Parkinson's disease; Participants with idiopathic Parkinson's disease who will undergo standardized driving simulator assessment during the best practically achievable ON-medication state. Motor status will be characterized at the time of testing using MDS-UPDRS Part III and Hoehn and Yahr staging, with timing of dopaminergic medication documented. Simulator-derived driving performance will be evaluated in relation to clinical and previously obtained functional measures and compared with healthy controls and participants with multiple sclerosis.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	During the single standardized driving simulator assessment, approximately 30-60 minutes
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.	During standardized hazard events within the single driving simulator assessment, approximately 30-60 minutes
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.	During predefined car-following segments within the single driving simulator assessment, approximately 30-60 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	During predefined speed-maintenance segments within the single driving simulator assessment, approximately 30-60 minutes
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.	During predefined braking events within the single driving simulator assessment, approximately 30-60 minutes
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.	During predefined critical traffic events within the single driving simulator assessment, approximately 30-60 minutes
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.	During predefined lane-change scenarios within the single driving simulator assessment, approximately 30-60 minutes
Number of Traffic Rule Violations	Total number of predefined traffic-rule violations recorded during the simulator assessment, including red-light or stop-sign violations, failure to yield, speeding events, and incorrect lane use. Events will be automatically recorded or derived from synchronized simulator telemetry according to prespecified scenario rules.	During the single standardized driving simulator assessment, approximately 30-60 minutes
Number of Collisions During Simulated Driving	Total number of collisions occurring during the standardized simulator assessment. Collisions may additionally be categorized according to the object involved, such as another vehicle, pedestrian, or road infrastructure.	During the single standardized driving simulator assessment, approximately 30-60 minutes
Steering Wheel Angle Variability	Variability of steering-wheel angle during predefined driving segments, quantified using the standard deviation of steering-wheel angle. Higher values indicate greater variability in steering input and may reflect less stable vehicle control.	During predefined driving segments within the single driving simulator assessment, approximately 30-60 minutes
Steering Smoothness	Smoothness of steering control derived from the temporal characteristics of steering-wheel movement, including steering jerk calculated from steering kinematics. Higher jerk values indicate less smooth steering control.	During predefined steering-demand segments within the single driving simulator assessment, approximately 30-60 minutes

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	During the single standardized driving simulator assessment, approximately 30-60 minutes
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	During predefined lane-change and turning maneuvers within the single driving simulator assessment, approximately 30-60 minutes
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.	During the single standardized driving simulator assessment, approximately 30-60 minutes
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.	From start of simulator adaptation to completion or premature termination of the simulator session, approximately 30-60 minutes

Collaborators and Investigators

• Sponsor: University Hospital Olomouc
• Collaborators: Digiteq Automotive

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: September 3, 2026
• First Submitted That Met QC Criteria: September 3, 2026
• First Posted (Actual): September 9, 2026

Study Record Updates

• Last Update Posted (Actual): September 9, 2026
• Last Update Submitted That Met QC Criteria: September 3, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Multiple sclerosis; Parkinson's disease; Driving simulator; Driving performance; Neurological disorders; Human factors; Road safety
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Multiple Sclerosis; Parkinson Disease; Nervous System Diseases
• Other Study ID Numbers: NeuroSimDrive

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No