Early Detection of Selected Neuropathologies in Motor Vehicle Drivers (NeuroDrive)

University Hospital Olomouc

Status: Enrolling

Conditions: Multiple Sclerosis; Parkinson Disease

Study type: Observational

Funder types: Other

Identifiers

NCT07360886

OP JAK ITI VZ 1

CZ.02.01.01/00/23_021/0008829 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

200 participants in 2 patient groups

Parkinson disease cohort

Description:

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

Description:

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.