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

Alzheimer's Disease Clinical Trial

— MeMO-RV2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02176629
• Other study ID #: 14-PP-03
• Status: Completed
• Phase: N/A
• First received: June 25, 2014
• Last updated: August 31, 2015
• Start date: August 2014
• Est. completion date: February 2015

Study information

• Verified date: August 2015
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Cognition Disorders
• MCI
• Mild Cognitive Impairment

Intervention

Other:
• Condition virtual reality (VR) then Condition classic cognitive stimulation (CCS)

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

Locations

Country	Name	City	State
France	Institut Claude Pompidou	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No