Evaluation of a Virtual Reality-based Version of the Multiple Errands Test in Alcohol Use Disorder

Официальное название

Evaluation of a Virtual Reality-based Version of the Multiple Errands Test for the Assessment of Executive Functions in Alcohol Use Disorder

Обзор

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: 1. evaluate if the performance in the virtual version of the test is related to the performance in the original test in patients with AUD. 2. 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.

Подробное описание

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:

1. 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. 2. 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

Вмешательства

• Поведенческое Multiple Errand Test (MET)
  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).
• Поведенческое Virtual MET
  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) .

Первичные конечные точки

• Total number of errors on the test [Срок оценки: Baseline]

Вторичные конечные точки (4)

• Inefficiencies on the test [Срок оценки: Baseline]
• Rule breaks on the test [Срок оценки: Baseline]
• Interpretation failures on the test [Срок оценки: Baseline]
• Task failures on the test [Срок оценки: Baseline]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 2 центра

• CH Le Vinatier — Bron
• Hôpital de la Croix Rousse — Lyon

Идентификаторы

NCT: NCT07593664 · 2025-A00421-48

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗