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Идёт набор NCT07360886

Early Detection of Selected Neuropathologies in Motor Vehicle Drivers

— Наблюдательное Multiple Sclerosis Parkinson Disease

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Multiple Sclerosis, Parkinson Disease. Базовые параметры: 18 лет — 85 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Чехия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Подробное описание

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.

Первичные конечные точки

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

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Чехия · 1 центр
  • University hospital Olomouc — Olomouc

Идентификаторы

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

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗