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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Méline Devaluez, PhD
- Telefonnummer: +33437915514
- E-Mail: meline.devaluez@ch-le-vinatier.fr
Studieren Sie die Kontaktsicherung
- Name: Louis-Ferdinand LESPINE, PhD
- Telefonnummer: +33437915155
- E-Mail: Louis-ferdinand.LESPINE@ch-le-vinatier.fr
Studienorte
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Bron, Frankreich, 69500
- CH le Vinatier
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Lyon, Frankreich, 69004
- Hôpital de La Croix Rousse
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Kontakt:
- Louis-Ferdinand LESPINE, PhD
- Telefonnummer: 0033437915514
- E-Mail: Louis-ferdinand.LESPINE@ch-le-vinatier.fr
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
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)
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Sonstiges
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: 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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Aktiver Komparator: 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
|
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) . |
|
Aktiver Komparator: 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) . |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Total number of errors on the test
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Inefficiencies on the test
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Christophe ICARD, MD, CH le Vinatier
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2025-A00421-48
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
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-Sharing-Zeitrahmen
IPD-Sharing-Zugriffskriterien
Art der unterstützenden IPD-Freigabeinformationen
- ANALYTIC_CODE
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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