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Completed

NCT Number: NCT02176629

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

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.

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Key information

Conditions

MCI Alzheimer Disease Alzheimer's Disease Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Claude Pompidou

Nice, 06000, France

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Condition virtual reality (VR) then Condition classic cognitive stimulation (CCS)

Other

Condition classic cognitive stimulation (CCS) then Condition virtual reality (VR)

Other

Primary outcomes

  1. Evaluate the acceptability of the RV

    Time frame: At the end of experience (45 min)

    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

Secondary outcomes

  1. 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).

    Time frame: At the end of experience (45 min)

    • 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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

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

Acronym: MeMO-RV2

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 27, 2014
Registry last updated
Sep 1, 2015

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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