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- Essai clinique NCT07360886
Détection Précoce de Neuropathologies Sélectionnées chez les Conducteurs de Véhicules Motorisés (NeuroDrive)
Détection précoce de neuropathologies sélectionnées chez les conducteurs de véhicules à moteur
Aperçu de l'étude
Statut
Les conditions
Description détaillée
L'étude sera menée en deux phases. Dans un premier temps, une cohorte de participants en bonne santé subira une évaluation à l'aide du système de test de Vienne (VTS). Par la suite, une cohorte clinique comprenant des individus diagnostiqués avec la sclérose en plaques (SEP) ou la maladie de Parkinson (MP) sera recrutée. Chaque participant clinique effectuera un examen neurologique de base, comprenant l'évaluation cognitive de Montréal (MoCA), le test de marche de 25 pieds (25-FWT), le test des symboles et des chiffres (SDMT) et le test des neuf trous et chevilles (9-HPT). Ils subiront ensuite un test VTS.
Les patients atteints de MP seront classés selon l'échelle de Hoehn et Yahr, tandis que ceux atteints de SEP seront évalués à l'aide de l'échelle élargie de l'état d'invalidité (EDSS). L'objectif est de déterminer quels tests cliniques facilement accessibles présentent la corrélation la plus forte avec les résultats du VTS, identifiant ainsi des marqueurs fiables pouvant être intégrés aux évaluations médicales standard des conducteurs.
Dans la deuxième phase, les résultats paracliniques obtenus en dehors du cadre de cette étude seront utilisés pour renforcer la base de preuves. En fin de compte, le projet vise à proposer une équation de risque sous la forme d'une calculatrice pratique que les médecins peuvent utiliser pour évaluer l'aptitude à conduire d'un patient. Un résultat supplémentaire attendu est le développement d'interventions ciblées de formation cognitive et motrice pour aider les conducteurs atteints de neuropathologies à maintenir ou à améliorer leurs capacités de conduite sûre.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Ladislav Stanke, Ph.D.
- Numéro de téléphone: +420 588 443 713
- E-mail: Ladislav.Stanke@fnol.cz
Sauvegarde des contacts de l'étude
- Nom: Dalibor Zimek, M.D.
- Numéro de téléphone: +420 702 048 036
- E-mail: Dalibor.Zimek@fnol.cz
Lieux d'étude
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Olomouc Region
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Olomouc, Olomouc Region, Tchéquie, 779 00
- Recrutement
- University Hospital Olomouc
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Contact:
- Ladislav Stanke, Ph.D.
- Numéro de téléphone: +420 588 443 713
- E-mail: Ladislav.Stanke@fnol.cz
-
Contact:
- Dalibor Zimek, M.D.
- Numéro de téléphone: +420 702 048 036
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
Critères d'inclusion :
- Personne après signature du consentement éclairé.
- Après avoir satisfait aux critères diagnostiques valides pour le diagnostic neurologique donné.
- Possession d'un permis de conduire valide et preuve de conduite active.
- Limite d'âge de 18 à 85 ans.
Critères d'exclusion :
- Diagnostic avéré de démence basé sur un examen psychologique actuel (MMSE 24 points ou moins).
- Diagnostic d'une maladie ou d'une affection qui, selon la loi tchèque n° 277/2004 Coll., sur l'aptitude médicale à conduire des véhicules à moteur, telle que modifiée (notamment la loi n° 204/2025 Coll.), empêche ou limite significativement la capacité à conduire un véhicule à moteur en toute sécurité (par exemple démence, épilepsie, troubles sévères de la conscience).
- Âge inférieur à 18 ans.
- Âge supérieur à 85 ans.
- Dans la deuxième cohorte (patients atteints de sclérose en plaques), rechute avérée et traitée au cours des 6 semaines précédant l'inclusion dans l'étude.
- Dans la cohorte SEP, EDSS actuel > 6,5 points.
- Pour la cohorte MP, le score actuel à l'échelle de Hoehn et Yahr est supérieur ou égal à 4.
- Pour les deux cohortes, preuve d'une détérioration parainfectieuse démontrée par des tests de laboratoire.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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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, 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.
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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, 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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Vienna Test Systems (VTS) - Determination Test (DT)
Délai: Day 1
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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. |
Day 1
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Vienna Test Systems (VTS) - Reaction Test (RT)
Délai: Day 1
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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. |
Day 1
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Vienna Test Systems (VTS) - Response inhibition (INHIB)
Délai: Day 1
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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. |
Day 1
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Vienna Test Systems (VTS) - Vigilance/Sustained attention (WAFV) - Short version
Délai: Day 1
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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. |
Day 1
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Montreal Cognitive Assessment (MoCA)
Délai: Day 1
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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. |
Day 1
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25-Foot Walk Test (25-FWT)
Délai: Day 1
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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. |
Day 1
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Symbol Digit Modalities Test (SDMT)
Délai: Day 1
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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. |
Day 1
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Nine-Hole Peg Test (9-HPT)
Délai: Day 1
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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. |
Day 1
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Benton Visual Retention Test (BVRT)
Délai: Day 1
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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. |
Day 1
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The Big Five Inventory-2 Short Form (BFI-2-S)
Délai: Day 1
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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. |
Day 1
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Epworth Sleepiness Scale (ESS)
Délai: Day 1
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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. |
Day 1
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Beck's Depression Inventory (BDI-II)
Délai: Day 1
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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).
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Day 1
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Driving experience self-evaluation questionnaire
Délai: Day 1
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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).
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Day 1
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Synucleinopathies
- Maladies du cerveau
- Maladies du système nerveux central
- Maladies du système nerveux
- Maladies auto-immunes
- Maladies du système immunitaire
- Maladies auto-immunes démyélinisantes, SNC
- Maladies auto-immunes du système nerveux
- Maladies démyélinisantes
- Maladies neurodégénératives
- Troubles du mouvement
- Troubles parkinsoniens
- Maladies des noyaux gris centraux
- Sclérose en plaques
- Maladie de Parkinson
Autres numéros d'identification d'étude
- OP JAK ITI VZ 1
- CZ.02.01.01/00/23_021/0008829 (Autre subvention/numéro de financement: Operational Programme Jan Ámos Komenský financed by the European Union (EU) and the State Budget of Czech Republic)
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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