An observational study in Parkinson and Multiple Sclerosis, sponsored by University Hospital Olomouc. Not yet recruiting. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by University Hospital Olomouc · Observational
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.
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.
3,264 studies on the registry are indexed under Multiple Sclerosis; 659 are open to participants now.
This study's planned enrollment of 100 is close to the median of 100 across 970 observational studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →University Hospital Olomouc is the lead sponsor of 40 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For participants with multiple sclerosis:
For participants with Parkinson's disease:
For healthy control participants:
Exclusion Criteria:
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:
Additional exclusion criteria for participants with Parkinson's disease:
Additional exclusion criteria for healthy control participants:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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 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.
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 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.
Time frame: 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.
Time frame: During predefined car-following segments within the single driving simulator assessment, approximately 30-60 minutes
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 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: During predefined steering-demand segments within the single driving simulator assessment, approximately 30-60 minutes
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 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
Time frame: 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.
Time frame: 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.
Time frame: From start of simulator adaptation to completion or premature termination of the simulator session, approximately 30-60 minutes
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Dec 2027, 13 months later.
Of 334 non-industry observational studies under Multiple Sclerosis, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 73. This study's planned 13 months is below that.
Counting every sponsor, half of 425 studies reached it within 41 months; a quarter within 15 and three quarters within 75.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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University Hospital Olomouc