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

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

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.

Study Overview

• Status: Completed
• Conditions: Alzheimer's Disease; MCI
• Intervention / Treatment: 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
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nice, France, 06000
    • Institut Claude Pompidou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Study Director: Philippe ROBERT, PUPH, Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (ACTUAL): February 1, 2015
• Study Completion (ACTUAL): February 1, 2015

Study Registration Dates

• First Submitted: June 25, 2014
• First Submitted That Met QC Criteria: June 25, 2014
• First Posted (ESTIMATE): June 27, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): September 1, 2015
• Last Update Submitted That Met QC Criteria: August 31, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: Alzheimer's disease; Virtual Reality; mild cognitive impairment
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Cognition Disorders; Alzheimer Disease; Cognitive Dysfunction
• Other Study ID Numbers: 14-PP-03