Early Detection of Selected Neuropathologies in Motor Vehicle Drivers

NCT07360886 | Recruiting

• 2 other identifiers: OP JAK ITI VZ 1CZ.02.01.01/00/23_021/0008829
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to develop accessible methods for the early detection of selected neuropathologies in drivers, focusing on multiple sclerosis and Parkinson's disease. The primary objective is to identify clinical tests that correlate with outcomes from the Vienna Test System (VTS), thereby enabling early diagnosis without the need for complex neurological or neuropsychological assessments. Findings could improve the effectiveness of routine driver medical check-ups and inform future modifications to Czech traffic law to enhance road safety.

Conditions

Multiple Sclerosis; Parkinson Disease

Keywords

Neurology; Psychology; Traffic psychology; Vienna Test System; Driving abilities

Outcome Measures

Primary Outcomes (4)

• Vienna Test Systems (VTS) - Determination Test (DT)

  Vienna Test System (VTS) - Determination Test (DT). A computerized test of attention, stress tolerance, and psychomotor reactivity under complex conditions. Participants are presented with rapidly changing visual and auditory stimuli (e.g., colored lights, acoustic signals) and must respond as quickly as possible using multiple response keys or pedals. Scoring: outcomes include mean and median reaction time (ms), number of correct responses, omission errors (missed stimuli), commission errors (incorrect responses), and measures of performance stability across the task. Faster, more accurate, and stable performance indicates better attentional control and stress tolerance. Administration: conducted in a quiet environment with standardized VTS hardware and software. Trained staff provide uniform instructions and monitor performance.

  10 minutes

• Vienna Test Systems (VTS) - Reaction Test (RT)

  Vienna Test System (VTS) - Reaction Test (RT). A computerized assessment of simple and choice reaction time measuring perceptual speed and motor response. Participants are presented with visual and/or auditory stimuli and instructed to respond as quickly as possible by pressing a button (simple RT) or selecting the correct response among multiple options (choice RT). Scoring: main outcomes include mean reaction time (ms), number of correct responses, and error rates. Faster and more accurate responses indicate better psychomotor speed and attention. Separate scores are calculated for simple and choice conditions. Administration: conducted individually in a quiet, distraction-free environment using standardized VTS hardware and software. Trained staff provide standardized instructions and supervise.

  10 minutes

• Vienna Test Systems (VTS) - Response inhibition (INHIB)

  Vienna Test System (VTS) - Response Inhibition (INHIB). A computerized go/no-go paradigm measuring impulse control and inhibitory executive function. Participants are presented with a continuous sequence of visual stimuli on screen. They are instructed to respond via button press to "go" stimuli and withhold responses to "no-go" stimuli. Scoring: main outcomes include reaction time to go-stimuli, number of correct responses (hits), commission errors (responses to no-go stimuli), and omission errors (missed go-stimuli). Higher accuracy with fewer commission errors reflects better inhibitory control. Administration: conducted individually in a distraction-free environment using standardized VTS software and response panel. Trained staff provide instructions and supervise performance.

  15 minutes

• Vienna Test Systems (VTS) - Vigilance/Sustained attention (WAFV) - Short version

  Vienna Test System (VTS) - Vigilance/Sustained Attention (WAFV). A computerized test measuring sustained attention and vigilance. Participants monitor a continuous sequence of simple visual stimuli (e.g., small changes in geometric figures) presented at regular intervals. They are instructed to respond via button press whenever a predefined critical stimulus appears. Scoring: main outcomes include number of correct detections (hits), omissions (missed targets), false alarms (incorrect responses), and reaction times. Higher hits and faster, stable reaction times indicate better vigilance; higher omissions or false alarms indicate poorer sustained attention. Administration: conducted individually in a distraction-free environment using the standardized VTS software and response panel. Trained staff provide instructions and supervise.

  20 minutes

Secondary Outcomes (9)

• Montreal Cognitive Assessment (MoCA)

  15 minutes

• 25-Foot Walk Test (25-FWT)

  2 minutes

• Symbol Digit Modalities Test (SDMT)

  2 minutes

• Nine-Hole Peg Test (9-HPT)

  5 minutes

• Benton Visual Retention Test (BVRT)

  20 minutes

Study Arms (2)

Parkinson disease cohort

PD patients cohort will consist of 100 patients with parkinson disease aged between 18-85 years, with, with a balanced sex distribution to ensure representativeness and reduce gender bias. The target sample size (N = 100) has been chosen to provide adequate statistical power to detect moderate to strong correlations between clinical and paraclinical measures , we also want to distribute patients regularly across all those ages. Participants with premorbid cognitive impairment or those not clinically stable during the study period will be excluded, also participants with a Hoehn and Yahr stage greater than 4 will be excluded.

Multiple sclerosis cohort

Multiple sclerosis patient cohort will consist of 100 patients with multiple sclerosis. aged between 18-85 years, with, with a balanced sex distribution to ensure representativeness and reduce gender bias. The target sample size (N = 100) has been chosen to provide adequate statistical power to detect moderate to strong correlations between clinical and paraclinical measures , we also want to distribute patients regularly across all those ages. Participants with premorbid cognitive impairment or those not clinically stable during the study period will be excluded also an Expanded Disability Status Scale (EDSS) score above 6.5 will serve as an exclusion criterion.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients from the dispensary care of the neurological department of the University hospital Olomouc with the full access to the paraclinical data and demographic features.

You may qualify if:

• Person after signing informed consent.
• After meeting the valid diagnostic criteria for the given neurological diagnosis.
• Possession of a valid driver's license and proof of active driving.
• Age limit 18 - 85 years.

You may not qualify if:

• Proven diagnosis of dementia based on a current psychological examination (MMSE 24 points or less).
• Diagnosis of a disease or condition that, according to Czech Law. No. 277/2004 Coll., on medical fitness to drive motor vehicles, as amended (especially Law No. 204/2025 Coll.), prevents or significantly limits the ability to drive a motor vehicle safely (e.g. dementia, epilepsy, severe disorders of consciousness).
• Age less than 18 years.
• Age more than 85 years.
• In the MS cohort, current EDSS \> 6.5 points.
• For the PD cohort, the current Hoehn and Yahr scale score is greater than or equal to 4.
• For both cohorts, evidence of parainfectious deterioration as demonstrated by laboratory testing.

Sponsors & Collaborators

• University Hospital Olomouc: lead
• Palacky University: collaborator

Study Sites (1)

University hospital Olomouc

Olomouc, Olomoucký kraj, 779 00, Czechia

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis; Parkinson Disease

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

Dalibor Zimek, M.D.

CONTACT

+420 702 048 036; Dalibor.Zimek@fnol.cz

Ladislav Stanke, Ph.D.

CONTACT

+420 588 443 713; Ladislav.Stanke@fnol.cz

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: January 22, 2026
• Study Start: November 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)