NCT07809828Toborzás még nem indult
Driving Performance in Parkinson's Disease and Multiple Sclerosis Using a Driving Simulator
Simulator-Based Assessment of Driving Performance in Patients With Parkinson's Disease and Multiple Sclerosis
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. szept. 9.
Rövid összefoglaló (regiszter, angolul)
This prospective observational study investigates whether driving performance measured in a standardized driving simulator differs between people with Parkinson's disease, people with multiple sclerosis, and healthy drivers. Participants will complete a standardized simulated driving assessment designed to evaluate abilities relevant to safe driving, including lane keeping, speed control, vehicle following, responses to hazards, lane changes, navigation, and compliance with traffic rules. Driving simulator measures will also be examined in relation to clinical characteristics and results from previously performed cognitive, motor, and psychodiagnostic assessments in the patient groups. The main research question is whether a driving simulator can detect measurable patterns of driving performance associated with Parkinson's disease or multiple sclerosis when compared with healthy drivers. The study hypothesis is that participants with these neurological conditions will show differences in selected driving performance measures and that some of these differences will be associated with the clinical severity and functional manifestations of their disease. The study will also explore whether additional information from eye tracking, video-based measurements, and physiological signals can improve the characterization of driving performance. The results are intended to support the development of objective methods for studying driving-related functions in neurological disease. Simulator results will be used for research purposes and will not by themselves determine an individual's medical fitness to drive.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 100 (tervezett)
- Első benyújtás
- 2026. szept. 3.
- Kezdés
- 2026. nov. 1.
- Elsődleges befejezés
- 2027. dec. 1.
- Fő szponzor
- University Hospital Olomouc
- Betegségek
- Parkinson-kór, Sclerosis multiplex (SM)
- NCT-szám
- NCT07809828
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Tervezett résztvevők: 100
- 2026. nov. 1. és az elsődleges befejezés (2027. dec. 1.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- Less than 30 days since the most recent relapse or corticosteroid treatment for relapse.
- Hoehn and Yahr stage > 4 in the ON-medication state.
Más betegség
- Marked sleep deprivation, excessive fatigue, or another temporary condition that, in the judgment of the responsible study personnel, would substantially impair the ability to complete testing safely and validly.
- Clinically significant uncorrected visual or auditory impairment that prevents valid completion of the simulator assessment.
- Inability to understand study instructions or safely operate the driving simulator.
- EDSS score > 6.5.
- Additional exclusion criteria for participants with Parkinson's disease:
- Atypical parkinsonian syndrome.
- Deep brain stimulation in the main Parkinson's disease cohort.
- Clinical condition preventing testing during a sufficiently stable ON-medication period.
- Additional exclusion criteria for healthy control participants:
- Self-reported neurological disease or other health condition expected to substantially influence cognitive, sensory, or motor functions relevant to driving.
- Current psychiatric or medical condition that would prevent safe or valid completion of the simulator assessment.
- Current use of substances or medications producing an acute level of impairment incompatible with safe simulator testing.
Egyéb
- Acute medical or neurological deterioration that would prevent safe or valid completion of the driving simulator assessment.
- Current intoxication with alcohol or other psychoactive substances.
- Severe simulator sickness or current vestibular symptoms that prevent completion of simulator testing.
- Withdrawal of consent or refusal of data recording required for the study when no technically valid alternative method is available.
- Additional exclusion criteria for participants with multiple sclerosis:
- Current multiple sclerosis relapse.
Kiket keres a vizsgálat
- Age 18 to 85 years.
- Ability to understand study instructions and provide written informed consent.
- Valid driving license for passenger vehicles (Category B or equivalent).
- Active non-professional driving of a motor vehicle.
- Ability to understand the instructions and complete the standardized driving simulator assessment.
- For participants with multiple sclerosis:
- Confirmed diagnosis of multiple sclerosis according to applicable diagnostic criteria.
- Expanded Disability Status Scale (EDSS) score less than 6.5.
- Clinically stable disease at the time of simulator assessment.
- At least 6 weeks since the most recent multiple sclerosis relapse and any corticosteroid treatment for relapse.
- Previous completion of the psychodiagnostic and screening assessment used in the preceding OP-JAK research framework (NCT07360886) within 6 months before simulator testing, provided that no clinically relevant deterioration has occurred.
- Completion of the required neurological, ophthalmological, visual-field, and audiometric assessments before or on the day of simulator testing, as specified by the study protocol.
- For participants with Parkinson's disease:
- Confirmed diagnosis of idiopathic Parkinson's disease.
- Hoehn and Yahr less than stage IV in the ON-medication state.
- Clinically stable condition at the time of simulator assessment.
- Ability to undergo simulator testing during the best practically achievable ON-medication state.
- Previous completion of the psychodiagnostic and screening assessment used in the preceding OP-JAK research framework within 6 months before simulator testing, provided that no clinically relevant deterioration has occurred.
- Completion of the required neurological, ophthalmological, visual-field, and audiometric assessments before or on the day of simulator testing, as specified by the study protocol.
- For healthy control participants:
- No known neurological disorder expected to substantially affect driving performance.
- Self-reported current health status compatible with safe completion of the driving simulator assessment.
- Visual and auditory function, with usual correction if applicable, sufficient to safely and validly complete the simulator assessment.
Életkor a regiszterben: 18 év – 85 év · Nem: nők és férfiak · Egészséges önkénteseket is fogad
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