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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Méline Devaluez, PhD
- Telefonnummer: +33437915514
- E-post: meline.devaluez@ch-le-vinatier.fr
Studer Kontakt Backup
- Navn: Louis-Ferdinand LESPINE, PhD
- Telefonnummer: +33437915155
- E-post: Louis-ferdinand.LESPINE@ch-le-vinatier.fr
Studiesteder
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Bron, Frankrike, 69500
- CH le Vinatier
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Lyon, Frankrike, 69004
- Hôpital de La Croix Rousse
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Ta kontakt med:
- Louis-Ferdinand LESPINE, PhD
- Telefonnummer: 0033437915514
- E-post: Louis-ferdinand.LESPINE@ch-le-vinatier.fr
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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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Aktiv 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) . |
|
Aktiv komparator: Control group
Group of healthy volunteers
|
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) . |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Total number of errors on the test
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Inefficiencies on the test
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Christophe ICARD, MD, CH le Vinatier
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2025-A00421-48
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
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-delingstidsramme
Tilgangskriterier for IPD-deling
IPD-deling Støtteinformasjonstype
- ANALYTIC_CODE
Legemiddel- og utstyrsinformasjon, studiedokumenter
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