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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Méline Devaluez, PhD
- Numero di telefono: +33437915514
- Email: meline.devaluez@ch-le-vinatier.fr
Backup dei contatti dello studio
- Nome: Louis-Ferdinand LESPINE, PhD
- Numero di telefono: +33437915155
- Email: Louis-ferdinand.LESPINE@ch-le-vinatier.fr
Luoghi di studio
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Bron, Francia, 69500
- CH le Vinatier
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Lyon, Francia, 69004
- Hôpital de La Croix Rousse
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Contatto:
- Louis-Ferdinand LESPINE, PhD
- Numero di telefono: 0033437915514
- Email: Louis-ferdinand.LESPINE@ch-le-vinatier.fr
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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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Comparatore attivo: 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) . |
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Comparatore attivo: 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) . |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Total number of errors on the test
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Inefficiencies on the test
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Christophe ICARD, MD, CH le Vinatier
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2025-A00421-48
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
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.
Periodo di condivisione IPD
Criteri di accesso alla condivisione IPD
Tipo di informazioni di supporto alla condivisione IPD
- CODICE_ANALITICO
Informazioni su farmaci e dispositivi, documenti di studio
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