Clinical trial NCT02176629: Usability of Virtual Reality in Subjects With Mild Cognitive Impairment or Alzheimer's Disease
Official title: Usability of Virtual Reality in Subjects With Mild Cognitive Impairment or Alzheimer's Disease. MeMO-RV2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: MCI
Alzheimer's Disease
Keywords: Virtual Reality
mild cognitive impairment
Alzheimer's disease
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2014-06-27
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Evaluate the acceptability of the RV
timeFrame: At the end of experience (45 min)
Secondary outcomes:
measure: 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).
timeFrame: At the end of experience (45 min)
Other outcomes:
Locations:
city: Nice
country: France
facility: Institut Claude Pompidou
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Philippe ROBERT, PUPH
role: STUDY_DIRECTOR
References: