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Completed

NCT Number: NCT05996250

Tolerance of an Immersive Virtual Reality Task Evaluating the Spatial Memory of Elderly Subjects

Spatial navigation is a high-level cognitive function allowing animals and humans to orient and move in space by constructing a mental representation of the environment. This function has been identified as one of the very first to be affected by Alzheimer's disease, including at the early stages, before the appearance of other mnesic disorders that the latter causes, such as those of episodic memory. However, the neuropsychological tests currently used in the diagnosis of cognitive disorders do not allow effective assessment of spatial memory impairment, in particular because it is impractical to offer spatial orientation tasks in a consulting room. In this context, virtual reality offers very interesting perspectives: it makes it possible to create controlled environments to assess spatial memory, without leaving the place of consultation.

Before being able to test its possible diagnostic efficacy, it is imperative to test the feasibility as well as the reliability of this type of task on an elderly population with no cognitive impairment. The data currently available on immersion tolerance in virtual reality mainly concern young people aged 18 to 35 and little data is available concerning the elderly or very old.

If this task correctly assesses spatial navigation abilities, this study should find the effects of age and sex usually observed.

The aim of this study is to assess the tolerance of an immersive virtual reality task evaluating the spatial memory of elderly subjects and the effects of age, gender and level of education on performance.

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Key information

Conditions

Healthy Participants

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charpennes Geriatric Hospital, Lyon University Hospital

Villeurbanne, 69100, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participant aged 60 to 85
  • Participant affiliated or entitled to a social security scheme
  • Recruited participants must have been informed and consented in writing

Exclusion criteria

  • Participant with a diagnosis of cognitive impairment
  • Severe, progressive or unstable pathology whose nature may interfere with the evaluation variables (epilepsy, psychiatric or psychotic disorders in the acute phase, visual hallucinations, acute infection, lack of sleep)
  • Participant equipped with a pacemaker
  • Burns or sores on the upper part of the face or on the scalp
  • Consumption of toxic substances that can influence cognitive performance
  • Deafness or blindness that may compromise participant assessment or completion of tasks and scales
  • Participant under guardianship or curatorship or legal safeguard
  • Participant refusing to use an immersive virtual reality tool
  • Criterion for stopping the procedure under study: stopping the virtual reality task due to the participant's simulator sickness.
  • Montreal Cognitive Assessment (MOCA) score less than 26
  • MacNair Subjective Complaint Scale score greater than 16
  • AGGIR score (Autonomy, Gerontology Group Iso Resources) less than 5

Treatment and study plan

Immersive virtual reality task

Other

participants will have to wear a virtual reality headset connected to a remote control and will have to perform submersive virtual reality tasks

Primary outcomes

  1. Sickness Simulator Questionnaire (SSQ) score

    Time frame: The sickness simulator scale is assessed immediately after the immersive virtual reality task.

    This is a questionnaire composed of 16 items covering the potential symptoms of intolerance to a virtual reality tool.

    Each item is rated 0 (no symptom), 1 (mild symptom), 2 (moderate symptom) or 3 (severe symptom). The total score is obtained by multiplying the sum of the items by 3.74, and therefore varies from 0 to 180.

Secondary outcomes

  1. Time to complete the task in immersive virtual reality according to the age of the participants

    Time frame: through study completion, 1 year

    Time to complete the task in immersive virtual reality (in seconds) according to the age of participants (in years)

  2. Time to complete the task in immersive virtual reality (in seconds) according to the gender of participants (male or female)

    Time frame: through study completion, 1 year

    Time to complete the task in immersive virtual reality according to the gender of participants

  3. Time to complete the task in immersive virtual reality according to the number of years of study

    Time frame: through study completion, 1 year

    Time to complete the task in immersive virtual reality (in seconds) according to the number of years of study (from entry into primary school)

  4. Raw score on the Wechsler Memory Scale-III (MEM III) Spatial Memory subtest

    Time frame: through study completion, 1 year

    The test is designed for adults and the elderly to assess the performance of auditory memory, visual memory, memory immediate, delayed and visual working memory.The subtest used is the Spatial Memory subtest, it ranges from 0 to 28 (the higher the score, the better the performance).

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Tolerance of an Immersive Virtual Reality Task Evaluating the Spatial Memory of Elderly Subjects and the Effects of Age, Gender and Level of Education on Performance

Acronym: REVIAGE

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 18, 2023
Registry last updated
Jun 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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