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

NCT ID: NCT05996250

Last Updated: 2024-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-25
• Study Completion Date: 2024-05-28

Brief Summary

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.

Conditions

Healthy Participants

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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).

Group Type: OTHER

Immersive virtual reality task

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Charpennes Geriatric Hospital, Lyon University Hospital

Villeurbanne, , France

Countries

France

Other Identifiers

69HCL22_0203

Identifier Type: -

Identifier Source: org_study_id