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Multiple SclerosisNeuroDriveNCT07360886

Early Detection of Selected Neuropathologies in Motor Vehicle Drivers

An observational study of Multiple Sclerosis and Parkinson Disease, run by University Hospital Olomouc at 1 site in Czechia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Multiple Sclerosis, Parkinson Disease
How many people
200 participants
Where
1 siteCzechia
Study dates
1 May 2026to 31 Dec 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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 second cohort (patients with Multiple Sclerosis), proven and treated relapse in the last 6 weeks before inclusion in the study.
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

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

Czechia1 site, 1 recruiting
  • University hospital Olomouc

    Olomouc, Olomouc Region, 779 00

    Ladislav Stanke, Ph.D., +420 588 443 713, Ladislav.Stanke@fnol.cz

    Dalibor Zimek, M.D., +420 702 048 036

    Recruiting

Other trials in Czechia

About this study

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.

Read the detailed description

The study will be conducted in two phases. First, a cohort of healthy participants will undergo assessment using the Vienna Test System (VTS). Subsequently, a clinical cohort comprising individuals diagnosed with multiple sclerosis (MS) or Parkinson's disease (PD) will be recruited. Each clinical participant will complete a basic neurological examination, including the Montreal Cognitive Assessment (MoCA), 25-Foot Walk Test (25-FWT), Symbol Digit Modalities Test (SDMT), and Nine-Hole Peg Test (9-HPT). They will then undergo VTS testing.

Patients with PD will be classified according to the Hoehn and Yahr scale, while those with MS will be staged using the Expanded Disability Status Scale (EDSS). The aim is to determine which easily accessible clinical tests show the strongest correlation with VTS outcomes, thereby identifying reliable markers that can be incorporated into standard medical evaluations of drivers.

In the second phase, paraclinical findings obtained outside the scope of this study will be used to strengthen the evidence base. Ultimately, the project seeks to propose a risk equation in the form of a practical calculator that physicians can use when evaluating a patient's fitness to drive. An additional anticipated outcome is the development of targeted cognitive and motor training interventions to help drivers with neuropathologies maintain or improve safe driving abilities.

Keywords
Neurology, Psychology, Traffic psychology, Vienna Test System, Driving abilities
Medical subject headings
Multiple Sclerosis, Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07360886
Study groupRoleWhat they receive
Parkinson disease cohortPD 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, it is intended to acquire a regular distribution across all age groups . 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 cohortMultiple 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, it is intended to acquire a regular distribution across all age groups. 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Day 1

  2. 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.

    Measured: Day 1

  3. 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.

    Measured: Day 1

  4. 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.

    Measured: Day 1

Secondary outcomes (9)
  1. Montreal Cognitive Assessment (MoCA)

    Montreal Cognitive Assessment (MoCA). A clinician-administered screening tool for mild cognitive impairment covering multiple domains: attention, concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. The test consists of 30 items with a maximum total score of 30; higher scores = better cognition. A score of 26 or above is considered normal. If the participant has ≤12 years of formal education, +1 point is added.

    Administration: conducted face-to-face in a quiet environment by trained staff using validated language versions; completion requires ~10-15 minutes.

    Outcomes: total score and change from baseline.

    Measured: Day 1

  2. 25-Foot Walk Test (25-FWT)

    25-Foot Walk Test (25-FWT). A quantitative measure of ambulatory function and walking speed. Participants are instructed to walk 25 feet (7.62 m) as quickly and safely as possible. Two trials are performed, typically with a short rest interval, and the average time (in seconds) is recorded using a stopwatch. Lower times = better mobility. Use of customary assistive devices (e.g., cane, walker) is permitted and documented.

    Administration: conducted in a straight, unobstructed corridor with clearly marked start and finish lines. Trained staff provide standardized instructions and supervise for safety. Completion typically requires ~5 minutes.

    Outcomes: average time to walk 25 feet (7.62 meters), ability to complete the test, and change from baseline.

    Measured: Day 1

  3. Symbol Digit Modalities Test (SDMT)

    Symbol Digit Modalities Test (SDMT). A brief neurocognitive test of attention, processing speed, and visual scanning. Participants are shown a key pairing nine symbols with digits 1-9. Using this key, they write or orally state the digit corresponding to each symbol in a randomized sequence presented on the test form.

    Scoring: the number of correct substitutions completed in 90 seconds is counted. Higher scores = better cognitive performance. Errors are recorded but not included in the raw score. Written and oral versions are available; the same mode is used across visits for consistency.

    Administration: conducted in a quiet environment with standardized instructions, requiring ~5 minutes. Staff monitor to ensure task adherence.

    Outcomes: total correct substitutions and standard deviation change from the normal value.

    Measured: Day 1

  4. Nine-Hole Peg Test (9-HPT)

    Nine-Hole Peg Test (9-HPT). A standardized test of finger dexterity and fine motor function. Participants are instructed to place nine pegs into nine holes on a board, one at a time, as quickly as possible, and then remove them. Each hand is tested separately, typically with the dominant hand first, followed by the non-dominant hand.

    Scoring: performance time (in seconds) for each hand is recorded with a stopwatch. Lower times = better dexterity. Two consecutive trials per hand are averaged. If a peg is dropped, the participant retrieves it and continues.

    Administration: administered in a quiet environment by trained staff using standardized instructions. Completion time is usually 3-5 minutes for both hands.

    Outcomes: mean completion time for each hand and change from baseline.

    Measured: Day 1

  5. Benton Visual Retention Test (BVRT)

    A neuropsychological assessment of visual memory, perception, and visuoconstructive ability. Participants are shown a series of 10 geometric designs, each displayed for 10 seconds, and then asked to reproduce the design from memory using paper and pencil (Administration A). Alternate forms may be used to minimize practice effects.

    Scoring: each reproduction is scored for number correct (maximum = 10) and for errors (e.g., omissions, distortions, rotations, perseverations, misplacements). Higher correct scores indicate better performance, while higher error counts indicate impairment.

    Administration: conducted individually in a quiet setting by trained staff; typical completion ~15 minutes.

    Outcomes: total correct responses, total errors, and change from baseline.

    Measured: Day 1

  6. The Big Five Inventory-2 Short Form (BFI-2-S)

    Big Five Inventory-2 Short Form (BFI-2-S). A 30-item self-report assessing five personality domains: Extraversion, Agreeableness, Conscientiousness, Negative Emotionality, and Open-Mindedness. Items are rated on a 5-point Likert scale (1 = disagree strongly to 5 = agree strongly). For each domain, compute the mean of its 6 items after applying the manual's reverse-keying rules; higher scores = more of that trait. No total score is used.

    Administration: validated language version via paper or secure ePRO; typical completion ~5-7 min. Staff provide standardized instructions and check completeness.

    Outcomes: domain scores (1-5) and change from baseline. Timing: baseline and follow-ups within ±3 days of the visit window.

    Measured: Day 1

  7. Epworth Sleepiness Scale (ESS)

    An 8-item self-report of daytime sleepiness. Participants rate their chance of dozing in common situations from 0 (would never doze) to 3 (high chance). Total score = sum of items (range 0-24; higher = worse sleepiness). Severity bands: 0-5 normal, 6-10 higher-than-normal, 11-12 mild, 13-15 moderate, 16-24 severe.

    Administration: validated language version via paper or secure ePRO; typical completion ~2-3 min. Staff provide standardized instructions and check completeness before scoring.

    Outcomes: total score; change from baseline; response = ≥3-point reduction from baseline; remission = score ≤10.

    Measured: Day 1

  8. Beck's Depression Inventory (BDI-II)

    A 21-item self-report questionnaire assessing depressive symptoms over the past 2 weeks, including today. Each item is rated 0-3; total score ranges 0-63, with higher scores indicating more severe depression. Severity categories: 0-13 minimal, 14-19 mild, 20-28 moderate, 29-63 severe. The BDI-II is administered in validated language versions on paper or secure ePRO, requiring ~5-10 minutes. Staff provide standardized instructions and check completeness. Outcomes include total score, change from baseline, response (≥50% reduction from baseline), and remission (score ≤13).

    Measured: Day 1

  9. Driving experience self-evaluation questionnaire

    This self-report questionnaire captures recent driving exposure and perceived difficulties over the past month. Items use 7-point Likert scales anchored "Never (1)" to "Every drive (7)". Content includes deliberate avoidance of challenging conditions (night driving, heavy traffic, bad weather, highways, unfamiliar routes), fatigue while driving, uncertainty in traffic situations (e.g., speed limits, lane selection, right of way), perceived complexity/overload, inattention, vehicle-control errors (e.g., wrong gear, pedal mix-ups), oversight errors (e.g., missed lights/signs, failure to check mirrors), warnings from other road users, risk-taking, traffic-rule violations, and emotional arousal during driving. A brief exposure module records typical driving frequency, lifetime kilometers, and the frequency of driving in specific conditions. Higher scores indicate more frequent difficulties; the primary metric is the mean item score (1-7).

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2026
  2. Study start1 May 2026
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07360886
Sponsor's protocol ID
OP JAK ITI VZ 1
Other IDs
CZ.02.01.01/00/23_021/0008829
Acronym
NeuroDrive
Status last verified
Sep 2026
First submitted
13 Jan 2026
Last updated
8 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Multiple Sclerosis and Parkinson Disease, run by University Hospital Olomouc at 1 site in Czechia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dalibor Zimek, M.D. (+420 702 048 036, Dalibor.Zimek@fnol.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vienna Test Systems (VTS) - Determination Test (DT) (time frame: Day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.

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