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

June 4, 2024 updated by: Hospices Civils de Lyon

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Villeurbanne, France, 69100
        • Charpennes Geriatric Hospital, Lyon University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Immersive virtual reality task

The immersive virtual reality task, specifically designed for this research, is an adaptation to humans of Morris Pool. The virtual environment is composed of a circular arena 22 virtual meters in diameter, delimited by a low wall. It features two visual landmarks and an invisible object to find. The activity includes a control training sequence, an evaluation sequence and a delayed recall performed approximately 20 minutes after the end of the evaluation sequence.

The immersive reality task is performed once by the participants (the study consists on one visit).
Other: Immersive virtual reality task
participants will have to wear a virtual reality headset connected to a remote control and will have to perform submersive virtual reality tasks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
The sickness simulator scale is assessed immediately after the immersive virtual reality task.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
through study completion, 1 year
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
through study completion, 1 year
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)
through study completion, 1 year
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).
through study completion, 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2023

Primary Completion (Actual)

May 28, 2024

Study Completion (Actual)

May 28, 2024

Study Registration Dates

First Submitted

August 1, 2023

First Submitted That Met QC Criteria

August 16, 2023

First Posted (Actual)

August 18, 2023

Study Record Updates

Last Update Posted (Actual)

June 5, 2024

Last Update Submitted That Met QC Criteria

June 4, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 69HCL22_0203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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