- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07593664
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Méline Devaluez, PhD
- Phone Number: +33437915514
- Email: meline.devaluez@ch-le-vinatier.fr
Study Contact Backup
- Name: Louis-Ferdinand LESPINE, PhD
- Phone Number: +33437915155
- Email: Louis-ferdinand.LESPINE@ch-le-vinatier.fr
Study Locations
-
-
-
Bron, France, 69500
- CH le Vinatier
-
Lyon, France, 69004
- Hopital de la croix rousse
-
Contact:
- Louis-Ferdinand LESPINE, PhD
- Phone Number: 0033437915514
- Email: Louis-ferdinand.LESPINE@ch-le-vinatier.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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
|
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) . |
|
Active Comparator: 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) . |
|
Active Comparator: 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) . |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total number of errors on the test
Time Frame: Baseline
|
Total number of errors on the MET and the V-MET. Errors include:
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Inefficiencies on the test
Time Frame: Baseline
|
Inefficiencies on the MET/V-MET : a more effective action could have been made Can be infinite
|
Baseline
|
|
Rule breaks on the test
Time Frame: Baseline
|
Rule breaks on the MET / V-MET : a specific rule is broken
|
Baseline
|
|
Task failures on the test
Time Frame: Baseline
|
Task failures on the MET / V-MET : task not carried out or not completely completed
|
Baseline
|
|
Interpretation failures on the test
Time Frame: Baseline
|
Interpretation failures on the MET/V-MET : the task is misunderstood or misinterpreted
|
Baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christophe ICARD, MD, CH le Vinatier
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-A00421-48
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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 Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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