- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07360886
운전자의 선별된 신경병리학적 이상 조기 발견 (NeuroDrive)
운전자의 선택된 신경병리학적 상태 조기 발견
연구 개요
상세 설명
이 연구는 두 단계로 진행됩니다. 먼저, 건강한 참가자 코호트를 대상으로 비엔나 테스트 시스템(VTS)을 이용한 평가가 실시됩니다. 이후, 다발성 경화증(MS) 또는 파킨슨병(PD)으로 진단된 개인들로 구성된 임상 코호트를 모집합니다. 각 임상 참가자는 몬트리올 인지 평가(MoCA), 25피트 걷기 검사(25-FWT), 기호 숫자 양식 검사(SDMT), 9홀 페그 검사(9-HPT)를 포함한 기본 신경학적 검사를 완료합니다. 그런 다음 VTS 검사를 받게 됩니다.
PD 환자는 호엔과 야르 척도에 따라 분류되며, MS 환자는 확장 장애 상태 척도(EDSS)를 사용하여 병기를 분류합니다. 목표는 쉽게 접근 가능한 임상 검사 중 VTS 결과와 가장 강한 상관관계를 보이는 검사를 확인하여, 운전자에 대한 표준 의학 평가에 통합할 수 있는 신뢰할 수 있는 지표를 식별하는 것입니다.
두 번째 단계에서는 이 연구 범위 외에서 얻은 부속 임상 소견을 사용하여 근거 기반을 강화합니다. 궁극적으로, 이 프로젝트는 의사가 환자의 운전 적합성을 평가할 때 사용할 수 있는 실용적인 계산기 형태의 위험 방정식을 제안하는 것을 목표로 합니다. 추가적으로 기대되는 결과는 신경병리학적 문제를 가진 운전자가 안전 운전 능력을 유지하거나 향상시키도록 돕기 위한 표적 인지 및 운동 훈련 중재의 개발입니다.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Ladislav Stanke, Ph.D.
- 전화번호: +420 588 443 713
- 이메일: Ladislav.Stanke@fnol.cz
연구 연락처 백업
- 이름: Dalibor Zimek, M.D.
- 전화번호: +420 702 048 036
- 이메일: Dalibor.Zimek@fnol.cz
연구 장소
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Olomouc Region
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Olomouc, Olomouc Region, 체코, 779 00
- 모병
- University Hospital Olomouc
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연락하다:
- Ladislav Stanke, Ph.D.
- 전화번호: +420 588 443 713
- 이메일: Ladislav.Stanke@fnol.cz
-
연락하다:
- Dalibor Zimek, M.D.
- 전화번호: +420 702 048 036
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
포함 기준:
- 정보에 입각한 동의서를 서명한 사람.
- 주어진 신경학적 진단에 대한 유효한 진단 기준을 충족한 후.
- 유효한 운전면허증 및 활발한 운전 증명을 소지.
- 연령 제한 18 - 85세.
제외 기준:
- 현재 심리 검사(MMSE 24점 이하)를 기반으로 치매 진단이 확인된 경우.
- 체코 법률 No. 277/2004 Coll., 개정된 자동차 운전 의학적 적합성에 관한 법률(특히 법률 No. 204/2025 Coll.)에 따라 자동차를 안전하게 운전하는 능력을 방해하거나 상당히 제한하는 질병 또는 상태 진단(예: 치매, 간질, 심각한 의식 장애).
- 연령 18세 미만.
- 연령 85세 초과.
- 두 번째 코호트(다발성 경화증 환자)에서, 연구 포함 전 최근 6주 동안 확인되고 치료된 재발.
- MS 코호트에서, 현재 EDSS > 6.5점.
- PD 코호트의 경우, 현재 Hoehn and Yahr 척도 점수가 4 이상.
- 두 코호트 모두에 대해, 실험실 검사로 입증된 감염 관련 악화 증거.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Vienna Test Systems (VTS) - Determination Test (DT)
기간: 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)
기간: 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)
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Montreal Cognitive Assessment (MoCA)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- OP JAK ITI VZ 1
- CZ.02.01.01/00/23_021/0008829 (기타 보조금/기금 번호: Operational Programme Jan Ámos Komenský financed by the European Union (EU) and the State Budget of Czech Republic)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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