Evaluation of a Virtual Reality-based Version of the Multiple Errands Test in Alcohol Use Disorder (EVIMETAL)
Evaluation of a Virtual Reality-based Version of the Multiple Errands Test for the Assessment of Executive Functions in Alcohol Use Disorder
The goal of this study is to validate the virtual version of the Multiple Errands Test (V-MET) as a tool for assessing executive functions in patients with alcohol use disorder (AUD).
More specifically, the project aims to:
- evaluate if the performance in the virtual version of the test is related to the performance in the original test in patients with AUD.
- establish whether the virtual version of the test is sensitive enough to detect patients with or without an executive function deficit.
All participants will perform the original version (in a real-life supermarket) and the virtual version of the test (in a virtual reality environment).
Performance in the two versions of the test will be compared. Participants will also complete a battery of neuropsychological tests and questionnaires.
연구 개요
상세 설명
The project aims to validate the virtual version of the Multiple Errands Test (V-MET) as a tool for assessing executive function in patients with alcohol use disorder (AUD), in comparison to the original test (MET), by:
- establishing the ecological validity of the V-MET: a high correlation between performance on the MET and performance on the V-MET (total number of errors) in patients with TUAL and executive dysfunction.
- establishing the sensitivity of the V-MET (to executive dysfunction): significant difference between V-MET performance in patients with an AUD and executive dysfunction versus (a) patients without executive dysfunction and (b) "healthy" volunteers
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Méline Devaluez, PhD
- 전화번호: +33437915514
- 이메일: meline.devaluez@ch-le-vinatier.fr
연구 연락처 백업
- 이름: Louis-Ferdinand LESPINE, PhD
- 전화번호: +33437915155
- 이메일: Louis-ferdinand.LESPINE@ch-le-vinatier.fr
연구 장소
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Bron, 프랑스, 69500
- CH le Vinatier
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Lyon, 프랑스, 69004
- Hôpital de La Croix Rousse
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연락하다:
- Louis-Ferdinand LESPINE, PhD
- 전화번호: 0033437915514
- 이메일: Louis-ferdinand.LESPINE@ch-le-vinatier.fr
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- written consent
- Normal or corrected vision and hearing
- Membership or entitlement to a social security plan
- spoken and written French
- third party liability insurance
for patients only :
- at least 6 criteria for AUD based on the Diagnostic and statistical manual of mental disorders
- At the end of withdrawal: treatment with a diazepam equivalent of ≤ 20 mg/day
Exclusion Criteria:
- under tutorship/ judicial protection
- Sensory or motor impairment (impeding the use of virtual reality and/or mobility)
- Severe neurological disorder (such as dementia or Korsakoff's syndrome)
- Photosensitive epilepsy (contraindication for the use of virtual reality)
- Any other condition deemed incompatible with the study, at the investigator's discretion
- Montreal Cognitive Assessment (MoCA) score < 10 (severe cognitive impairment)
- Breastfeeding or pregnant women
- Familiarity with the supermarket visited during the MET test
For controls only :
- History of alcohol use disorder
- score ≥ 8 on the Alcohol Use Disorders Identification Test
- Score on the Frontal Assessment Battery < 16 (or < 15 if education is below secondary level)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: AUD group with executive function deficit
Group of patients with alcohol use disorder and a deficit in executive functions as assessed by the Frontal Assessment Battery
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The test takes place in a real supermarket.
Participants must complete a list of tasks (e.g., purchasing certain items, collecting some information) while adhering to rules (e.g., not visiting the same place twice, etc).
The test takes place in a virtual supermarket, developed on the C2Neuro app by C2CARE®. Participants must complete a similar list of tasks to the MET (e.g., purchasing certain items, collecting some information) and adhere to similar to rules (e.g., not visiting the same place twice, etc) . |
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활성 비교기: AUD group without executive function deficit
Group of patients with alcohol use disorder but without a deficit in executive functions as assessed by the Frontal Assessment Battery
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The test takes place in a real supermarket.
Participants must complete a list of tasks (e.g., purchasing certain items, collecting some information) while adhering to rules (e.g., not visiting the same place twice, etc).
The test takes place in a virtual supermarket, developed on the C2Neuro app by C2CARE®. Participants must complete a similar list of tasks to the MET (e.g., purchasing certain items, collecting some information) and adhere to similar to rules (e.g., not visiting the same place twice, etc) . |
|
활성 비교기: Control group
Group of healthy volunteers
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The test takes place in a real supermarket.
Participants must complete a list of tasks (e.g., purchasing certain items, collecting some information) while adhering to rules (e.g., not visiting the same place twice, etc).
The test takes place in a virtual supermarket, developed on the C2Neuro app by C2CARE®. Participants must complete a similar list of tasks to the MET (e.g., purchasing certain items, collecting some information) and adhere to similar to rules (e.g., not visiting the same place twice, etc) . |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Total number of errors on the test
기간: Baseline
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Total number of errors on the MET and the V-MET. Errors include:
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Baseline
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Inefficiencies on the test
기간: Baseline
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Inefficiencies on the MET/V-MET : a more effective action could have been made Can be infinite
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Baseline
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Rule breaks on the test
기간: Baseline
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Rule breaks on the MET / V-MET : a specific rule is broken
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Baseline
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Task failures on the test
기간: Baseline
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Task failures on the MET / V-MET : task not carried out or not completely completed
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Baseline
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Interpretation failures on the test
기간: Baseline
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Interpretation failures on the MET/V-MET : the task is misunderstood or misinterpreted
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Baseline
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공동 작업자 및 조사자
수사관
- 수석 연구원: Christophe ICARD, MD, CH le Vinatier
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2025-A00421-48
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Individual participant data (IPD) underlying the results reported in this study might be shared, including de-identified demographic data, baseline characteristics, outcome measures, and variables necessary to reproduce the analyses. All data will be fully anonymized to protect participant confidentiality. A data dictionary and relevant metadata might also be provided to facilitate interpretation and reuse.
The analytic code will be provided at the time of publication of the primary study results. De-identified IPD will be shared via an open science repository such as Open Science Framework and may also be made available upon request.
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- ANALYTIC_CODE
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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