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

• ClinicalTrials.gov Identifier: NCT01798199
• Recruitment Status: Completed
• First Posted: February 25, 2013
• Last Update Posted: September 1, 2015
• Sponsor: Centre Hospitalier Universitaire de Nice
• Information provided by (Responsible Party): Centre Hospitalier Universitaire de Nice

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.

Condition or disease	Intervention/treatment	Phase
Alzheimer's Disease	Other: The training by Verve System	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 21 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• 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 Start Date: May 2013
• Actual Primary Completion Date: September 2014
• Actual Study Completion Date: September 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: Alzheimer disease	Other: The training by Verve System

Outcome Measures

Primary Outcome Measures :

1. the participants and careers acceptability [ Time Frame: 8 weeks ]
   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 :

1. 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 ]
   To assess the impact of behavioral disturbances over the use of the VR using the NPI and the Apathy Inventory
2. 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 ]
   To describe the parameters those facilitate engagement within the designs of VERVE VR setting using the engagement scale OME
3. 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 ]
   To assess the potential acceptability and preventive effectiveness of such setting in home setting using visual analogic scale and EQ-D6
4. To assess cognitive impact of the light VERVE setting. Using Stroop, TMT, VAT and functional task (IADL) [ Time Frame: First day and 4 weeks ]
   To assess cognitive impact of the light VERVE setting. Using Stroop, TMT, VAT and functional task (IADL)

Eligibility Criteria

• Ages Eligible for Study: 60 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

-

Contacts and Locations

Locations

France

CHU de Nice

Nice, France, 06000

EHPAD Valrose

Nice, France, 06000

EHPAD Villa Hélios Saint Jean

Nice, France, 06000

Sponsors and Collaborators

Centre Hospitalier Universitaire de Nice

Investigators

• Study Director: Philippe ROBERT, PU-PH; Centre Hospitalier Universitaire de Nice
• Study Chair: Renaud DAVID, PH; CHU Nice
• Study Chair: Guillaume SACCO, PH; Centre Hospitalier Universitaire de Nice
• Study Chair: Jean Michel TURPIN, PH; Centre Hospitalier Universitaire de Nice

More Information

• Responsible Party: Centre Hospitalier Universitaire de Nice
• ClinicalTrials.gov Identifier: NCT01798199
• Other Study ID Numbers: 12-PP-04
• First Posted: February 25, 2013
• Last Update Posted: September 1, 2015
• Last Verified: August 2015

Keywords provided by Centre Hospitalier Universitaire de Nice:

Alzheimer; virtual reality system; Alzheimer's disease related conditions

Additional relevant MeSH terms:

Alzheimer Disease; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders