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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT02176629
First received: June 25, 2014
Last updated: August 13, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
MCI
Alzheimer's Disease
Other: Condition virtual reality (VR) then Condition classic cognitive stimulation (CCS)
Other: Condition classic cognitive stimulation (CCS) then Condition virtual reality (VR)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Usability of Virtual Reality in Subjects With Mild Cognitive Impairment or Alzheimer's Disease. MeMO-RV2

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:
  • Evaluate the acceptability of the RV [ Time Frame: At the end of experience (45 min) ] [ Designated as safety issue: No ]

    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 Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    • 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.


Estimated Enrollment: 60
Study Start Date: August 2014
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Condition virtual reality (VR)
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)
Active Comparator: Condition classic cognitive stimulation (CSC)
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)

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02176629

Locations
France
Institut Claude Pompidou
Nice, France, 06000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
Study Director: Philippe ROBERT, PUPH CHU de Nice
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT02176629     History of Changes
Other Study ID Numbers: 14-PP-03
Study First Received: June 25, 2014
Last Updated: August 13, 2014
Health Authority: France: Committee for the Protection of Personnes

Keywords provided by Centre Hospitalier Universitaire de Nice:
Virtual Reality
mild cognitive impairment
Alzheimer's disease

Additional relevant MeSH terms:
Alzheimer Disease
Cognition Disorders
Mild Cognitive Impairment
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on October 23, 2014