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

NCT ID: NCT02176629

Last Updated: 2015-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2015-02-28

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.

Detailed Description

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Conditions

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MCI Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Condition virtual reality (VR)

The subject is placed in front of a Barcotm screen capable of displaying high quality images.

Group Type EXPERIMENTAL

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

Intervention Type OTHER

Condition classic cognitive stimulation (CSC)

It is proposed about using the test dam Zazzo suitable for elderly. This classic test measures sustained attention.

Group Type ACTIVE_COMPARATOR

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

Intervention Type OTHER

Interventions

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

Intervention Type OTHER

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

Intervention Type OTHER

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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philippe ROBERT, PUPH

Role: STUDY_DIRECTOR

Centre Hospitalier Universitaire de Nice

Locations

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Institut Claude Pompidou

Nice, , France

Site Status

Countries

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France

Other Identifiers

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14-PP-03

Identifier Type: -

Identifier Source: org_study_id

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