Usability of Virtual Reality in Subjects With Mild Cognitive Impairment or Alzheimer's Disease

Study Overview
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Brief Summary
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Cognitive and memory problems characterize Alzheimer's disease (AD). Along with these disorders, psychological and behavioral symptoms (also known as neuropsychiatric symptoms) , as well as pathophysiological processes are frequently found and involved significantly in maintaining autonomy, prognosis and treatment of the disease. Apathy or disorder motivation is the most common disorder behavior and early stages of cognitive impairment. Apathy is particularly associated with cognitive difficulties such as attention deficit disorder - concentration. In terms of prevention as term care , there is now a broad consensus that interventions on cognition and behavior must not be limited to pharmacological treatment but should also promote non-drug approaches. Interest in video games (serious games and serious games) as intervention support rehabilitation is growing. Similarly, the virtual reality (VR) and the new information technologies and communications offer significant opportunities in terms of rehabilitation and therapeutic assistance. This protocol is part of a European project to propose techniques for improving the treatment of people at risk of social exclusion ( VERVE project ) aims . A first experiment conducted in 2013 showed the acceptability of Virtual Reality (VR) in healthy elderly subjects. In a second step , it is important to validate the feasibility of using the RV or in frail subjects with mild cognitive impairment or Alzheimer's disease in mild to moderate in a clinical environment. This is a biomedical , randomized given to a group of patients with mild cognitive impairment or Alzheimer's disease & diseases associated with mild to moderate.

Official Title
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Usability of Virtual Reality in Subjects With Mild Cognitive Impairment or Alzheimer's Disease. MeMO-RV2

Conditions
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MCI, Alzheimer's Disease

Intervention / Treatment
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* Other: Condition virtual reality (VR) then Condition classic cognitive stimulation (CCS)
* Other: Condition classic cognitive stimulation (CCS) then Condition virtual reality (VR)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female age ≥ 60 years. Introducing either: MCI diagnosis (ICD-10) diagnosis of Alzheimer's disease or mixed mild to moderate (ICD 10). Subject undisturbed locomotion requiring the use of a walking aid. Score at the Mini Mental Test (MMSE) between 16 and 28. Exclusion Criteria: Presence of psychiatric disorders Presence of eye diseases causing blurred vision can not be corrected with lenses or glasses. Presence of auditory pathologies causing a significant decrease in hearing unaided. High sensitivity to motion sickness. migraine disease. Subject epileptic. Subject vulnerable

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Condition virtual reality (VR)<br>The subject is placed in front of a Barcotm screen capable of displaying high quality images. | Other: Condition virtual reality (VR) then Condition classic cognitive stimulation (CCS)<br> <br> |
| Active Comparator: Condition classic cognitive stimulation (CSC)<br>It is proposed about using the test dam Zazzo suitable for elderly. This classic test measures sustained attention. | Other: Condition classic cognitive stimulation (CCS) then Condition virtual reality (VR)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the acceptability of the RV | Analog scale assessment of satisfaction from 0 to 100% is given at the end of experience about that evaluates: The general acceptability of the RV His sense of security The environment of RV The degree of motivation | At the end of experience (45 min) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the motivation of subjects (interest, cognition) is greater in the virtual environment during the VR experience compared to a conventional cognitive stimulation activity (CSC). | Percentage of membership: relationship between time spent playing in the subject and the total time required by the experiment (Comparison of the two conditions (RV vs SCC)); Degree of performance: number of cognitive targets found by the subject during the experiment. (Comparison of the two conditions (RV vs SCC)); Degree of attention: the number of errors in target detection; Evaluation of the degree of presence of participants (condition RV) using the ITC-SOPI. | At the end of experience (45 min) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mild cognitive impairment, Alzheimer's disease, Virtual Reality