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Vanquishing Apathy Through E-inclusion Using Realistic Virtual Environment Project (VERVE)

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
The training by Verve System
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Alzheimer's Disease focused on measuring Alzheimer, virtual reality system, Alzheimer's disease related conditions

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria to MILD COGNITIVE IMPAIRMENT:

  • Male or Female aged ≥ 60 years.
  • Subject presenting a diagnosis of MCI according to the criteria of the National Institute on Aging and Alzheimer Association group (Albert M.S., 2011) ; or Alzheimer disease at the prodromal stage (Dubois B., 2010 )
  • Subject presenting a score of 0 at the " Tremor " and " Rigidity " items from the UPDRS III
  • Patient not presenting a major depression episode according to the DSM IV-R;
  • Be affiliate to the social security system (For French patients only);
  • Case of patients under guardianship after agreement of the guardian (legal entity);
  • Signed and dated a written informed consent obtained from the subject

Exclusion Criteria to MILD COGNITIVE IMPAIRMENT:

-

Sites / Locations

  • CHU de Nice
  • EHPAD Valrose
  • EHPAD Villa Hélios Saint Jean

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Alzheimer disease

Arm Description

Outcomes

Primary Outcome Measures

the participants and careers acceptability
The primary objective is to evaluate the participants and careers acceptability in short and long term use of the VERVE light portable system used for cognitive stimulation of patients with cognitive pathologies.

Secondary Outcome Measures

To assess the impact of behavioral disturbances over the use of the VR using the NPI and the Apathy Inventory
To assess the impact of behavioral disturbances over the use of the VR using the NPI and the Apathy Inventory
To describe the parameters those facilitate engagement within the designs of VERVE VR setting using the engagement scale OME
To describe the parameters those facilitate engagement within the designs of VERVE VR setting using the engagement scale OME
To assess the potential acceptability and preventive effectiveness of such setting in home setting using visual analogic scale and EQ-D6
To assess the potential acceptability and preventive effectiveness of such setting in home setting using visual analogic scale and EQ-D6
To assess cognitive impact of the light VERVE setting. Using Stroop, TMT, VAT and functional task (IADL)
To assess cognitive impact of the light VERVE setting. Using Stroop, TMT, VAT and functional task (IADL)

Full Information

First Posted
November 21, 2012
Last Updated
August 31, 2015
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT01798199
Brief Title
Vanquishing Apathy Through E-inclusion Using Realistic Virtual Environment Project
Acronym
VERVE
Official Title
VERVE* PROJECT: Study of the Acceptability of a Virtual Reality System on the Cognitive Stimulation of Patients With Alzheimer's Disease or Related Conditions. (*Vanquishing Apathy Through E-inclusion Using Realistic Virtual Environment)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Virtual environments and information communication technologies (ICT) offer large perspectives in the field of assistive care and rehabilitation. As potentially endless, the scenarios and environment used using 3D can provide immersive social and interactive context for enjoyable and therapeutic exercises in the aging population. In addition it is also possible to use this type of serious game and scenario in very easy to use devices such as lap top or tablet. Social exclusion has many causes, Apathy as one of the most common behavioural disturbances found in old adults populations alters significantly social and emotional interaction. Even though, progress in VR has been made over the past year, the presence of such technology in daily living space is still at the embryonic stage. The European e-Inclusion policy stresses the importance of ICT in improving the quality of life in potentially disadvantaged groups, including older people and persons. The VERVE project is developing ICT tools to support the treatment of people who are at risk of social exclusion due to apathy associated with a disability. As people aged and autonomy worsen fear for safety and comfortable means to maintain social and Health Related Quality of Life (HRQL) status are public health issues. Moreover, even though older adults would like to perform some activities such as walking in the streets some are reluctant to go out of their homes as the external environment is perceived as potentially unsafe. Apathy, the most common behavioural symptoms in aging population is characterized by symptoms of reduced initiation and responsiveness to environmental interactions. The syndrome of Apathy takes form of diminished goal-directed behaviour, characterised by emotional blunting, loss of initiative and loss of interest. Apathy along with the nosological characteristics of dementia induces impairment in autonomy level and therefore dependence as cognitive impairments worsened. The importance of stimulation could be related to the concept of engagement defined as the act of being occupied or involved with an external stimulus. Engaging older person with or without Alzheimer's disease and related disorders in appropriate activities has been shown to yield beneficial HRQL effects such increasing positive emotion, improving cognition, functional autonomy and quality of life. Accordingly, enriched environments with high definition virtual representation of cities and activities of interest have the potentials not only to encourage patients to get active in a safe and interactive environment but also to create access to enjoyable and stimulating settings for the more severe patients. The VR setting from VERVE proposed personalised and populated environments available on two different, but interlinked hardware platforms: 1/: standard gaming set-up in the home, nursing home or day hospital therapy group; and 2/ mobile tracked internet devices (e.g.,IPad). The system will ensure maximum openness and dissemination by using 3D Web technologies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Alzheimer, virtual reality system, Alzheimer's disease related conditions

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alzheimer disease
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
The training by Verve System
Primary Outcome Measure Information:
Title
the participants and careers acceptability
Description
The primary objective is to evaluate the participants and careers acceptability in short and long term use of the VERVE light portable system used for cognitive stimulation of patients with cognitive pathologies.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
To assess the impact of behavioral disturbances over the use of the VR using the NPI and the Apathy Inventory
Description
To assess the impact of behavioral disturbances over the use of the VR using the NPI and the Apathy Inventory
Time Frame
at 3, 4 and 8 weeks
Title
To describe the parameters those facilitate engagement within the designs of VERVE VR setting using the engagement scale OME
Description
To describe the parameters those facilitate engagement within the designs of VERVE VR setting using the engagement scale OME
Time Frame
at 1, 2, 3, a weeks
Title
To assess the potential acceptability and preventive effectiveness of such setting in home setting using visual analogic scale and EQ-D6
Description
To assess the potential acceptability and preventive effectiveness of such setting in home setting using visual analogic scale and EQ-D6
Time Frame
at 3, 4, 8 weeks
Title
To assess cognitive impact of the light VERVE setting. Using Stroop, TMT, VAT and functional task (IADL)
Description
To assess cognitive impact of the light VERVE setting. Using Stroop, TMT, VAT and functional task (IADL)
Time Frame
First day and 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria to MILD COGNITIVE IMPAIRMENT: Male or Female aged ≥ 60 years. Subject presenting a diagnosis of MCI according to the criteria of the National Institute on Aging and Alzheimer Association group (Albert M.S., 2011) ; or Alzheimer disease at the prodromal stage (Dubois B., 2010 ) Subject presenting a score of 0 at the " Tremor " and " Rigidity " items from the UPDRS III Patient not presenting a major depression episode according to the DSM IV-R; Be affiliate to the social security system (For French patients only); Case of patients under guardianship after agreement of the guardian (legal entity); Signed and dated a written informed consent obtained from the subject Exclusion Criteria to MILD COGNITIVE IMPAIRMENT: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe ROBERT, PU-PH
Organizational Affiliation
Centre Hospitalier Universitaire de Nice
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Renaud DAVID, PH
Organizational Affiliation
CHU Nice
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Guillaume SACCO, PH
Organizational Affiliation
Centre Hospitalier Universitaire de Nice
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jean Michel TURPIN, PH
Organizational Affiliation
Centre Hospitalier Universitaire de Nice
Official's Role
Study Chair
Facility Information:
Facility Name
CHU de Nice
City
Nice
ZIP/Postal Code
06000
Country
France
Facility Name
EHPAD Valrose
City
Nice
ZIP/Postal Code
06000
Country
France
Facility Name
EHPAD Villa Hélios Saint Jean
City
Nice
ZIP/Postal Code
06000
Country
France

12. IPD Sharing Statement

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Vanquishing Apathy Through E-inclusion Using Realistic Virtual Environment Project

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