- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07360886
Tidlig oppdagelse av utvalgte nevropatologier hos førere av motorvogner (NeuroDrive)
Tidlig oppdagelse av utvalgte nevropatologier hos bilførere
Studieoversikt
Status
Forhold
Detaljert beskrivelse
Studien vil bli gjennomført i to faser. Først vil en kohort med friske deltakere gjennomgå vurdering ved hjelp av Vienna Test System (VTS). Deretter vil en klinisk kohort bestående av personer diagnostisert med multippel sklerose (MS) eller Parkinsons sykdom (PD) bli rekruttert. Hver klinisk deltaker vil fullføre en grunnleggende nevrologisk undersøkelse, inkludert Montreal Cognitive Assessment (MoCA), 25-Foot Walk Test (25-FWT), Symbol Digit Modalities Test (SDMT) og Nine-Hole Peg Test (9-HPT). Deretter vil de gjennomgå VTS-testing.
Pasienter med PD vil bli klassifisert i henhold til Hoehn and Yahr-skalaen, mens de med MS vil bli stadieinndelt ved hjelp av Expanded Disability Status Scale (EDSS). Målet er å finne ut hvilke lett tilgjengelige kliniske tester som viser sterkest korrelasjon med VTS-resultater, og dermed identifisere pålitelige markører som kan inkorporeres i standard medisinske vurderinger av førere.
I den andre fasen vil parakliniske funn innhentet utenfor denne studiens omfang bli brukt til å styrke evidensgrunnlaget. Til syvende og sist søker prosjektet å foreslå en risikoligning i form av en praktisk kalkulator som leger kan bruke når de vurderer en pasients egnskap til å kjøre. Et ytterligere forventet resultat er utviklingen av målrettede kognitive og motoriske treningsintervensjoner for å hjelpe førere med nevropatologier med å opprettholde eller forbedre trygge kjøreevner.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Ladislav Stanke, Ph.D.
- Telefonnummer: +420 588 443 713
- E-post: Ladislav.Stanke@fnol.cz
Studer Kontakt Backup
- Navn: Dalibor Zimek, M.D.
- Telefonnummer: +420 702 048 036
- E-post: Dalibor.Zimek@fnol.cz
Studiesteder
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Olomouc Region
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Olomouc, Olomouc Region, Tsjekkia, 779 00
- Rekruttering
- University Hospital Olomouc
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Ta kontakt med:
- Ladislav Stanke, Ph.D.
- Telefonnummer: +420 588 443 713
- E-post: Ladislav.Stanke@fnol.cz
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Ta kontakt med:
- Dalibor Zimek, M.D.
- Telefonnummer: +420 702 048 036
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inklusjonskriterier:
- Person etter signert informert samtykke.
- Etter å ha oppfylt gyldige diagnostiske kriterier for den gitte nevrologiske diagnosen.
- Besittelse av gyldig førerkort og dokumentasjon på aktiv kjøring.
- Aldersgrense 18 - 85 år.
Eksklusjonskriterier:
- Påvist demensdiagnose basert på en aktuell psykologisk undersøkelse (MMSE 24 poeng eller mindre).
- Diagnose av en sykdom eller tilstand som, i henhold til tsjekkisk lov nr. 277/2004 Coll., om medisinsk kjøreevne for motorkjøretøyer, endret (spesielt lov nr. 204/2025 Coll.), forhindrer eller betydelig begrenser evnen til å kjøre motorkjøretøy trygt (f.eks. demens, epilepsi, alvorlige bevissthetsforstyrrelser).
- Alder under 18 år.
- Alder over 85 år.
- I den andre kohorten (pasienter med multippel sklerose), påvist og behandlet forverring de siste 6 ukene før inkludering i studien.
- I MS-kohorten, nåværende EDSS > 6,5 poeng.
- For PD-kohorten, nåværende Hoehn og Yahr-skår er større enn eller lik 4.
- For begge kohorter, påvisning av parainfeksiøs forverring som demonstrert ved laboratorietesting.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Vienna Test Systems (VTS) - Determination Test (DT)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Montreal Cognitive Assessment (MoCA)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
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Studierekorddatoer
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Studiestart (Faktiske)
Primær fullføring (Antatt)
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Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Synukleinopatier
- Hjernesykdommer
- Sykdommer i sentralnervesystemet
- Sykdommer i nervesystemet
- Autoimmune sykdommer
- Sykdommer i immunsystemet
- Demyeliniserende autoimmune sykdommer, CNS
- Autoimmune sykdommer i nervesystemet
- Demyeliniserende sykdommer
- Nevrodegenerative sykdommer
- Bevegelsesforstyrrelser
- Parkinsonlidelser
- Basal ganglia sykdommer
- Multippel sklerose
- Parkinsons sykdom
Andre studie-ID-numre
- OP JAK ITI VZ 1
- CZ.02.01.01/00/23_021/0008829 (Annet stipend/finansieringsnummer: Operational Programme Jan Ámos Komenský financed by the European Union (EU) and the State Budget of Czech Republic)
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