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Recruiting NCT07360886

Early Detection of Selected Neuropathologies in Motor Vehicle Drivers

— Observational Multiple Sclerosis Parkinson Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Multiple Sclerosis, Parkinson Disease. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Czechia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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.

Primary outcome measures

  • Vienna Test Systems (VTS) - Determination Test (DT) [Time frame: 10 minutes]
  • Vienna Test Systems (VTS) - Reaction Test (RT) [Time frame: 10 minutes]
  • Vienna Test Systems (VTS) - Response inhibition (INHIB) [Time frame: 15 minutes]
  • Vienna Test Systems (VTS) - Vigilance/Sustained attention (WAFV) - Short version [Time frame: 20 minutes]
Secondary outcome measures (9)
  • Montreal Cognitive Assessment (MoCA) [Time frame: 15 minutes]
  • 25-Foot Walk Test (25-FWT) [Time frame: 2 minutes]
  • Symbol Digit Modalities Test (SDMT) [Time frame: 2 minutes]
  • Nine-Hole Peg Test (9-HPT) [Time frame: 5 minutes]
  • Benton Visual Retention Test (BVRT) [Time frame: 20 minutes]
  • The Big Five Inventory-2 Short Form (BFI-2-S) [Time frame: 15 minutes]
  • Epworth Sleepiness Scale (ESS) [Time frame: 5 minutes]
  • Beck's Depression Inventory (BDI-II) [Time frame: 8 minutes]
  • Driving experience self-evaluation questionnaire [Time frame: 10 minutes]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Czechia · 1 center
  • University hospital Olomouc — Olomouc

Identifiers

NCT: NCT07360886 · OP JAK ITI VZ 1 · CZ.02.01.01/00/23_021/0008829

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗