Vanquishing Apathy Through E-inclusion Using Realistic Virtual Environment Project

Alzheimer's Disease Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01798199
• Other study ID #: 12-PP-04
• Status: Completed
• Phase: N/A
• First received: November 21, 2012
• Last updated: August 31, 2015
• Start date: May 2013
• Est. completion date: September 2014

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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:

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Other:
• The training by Verve System

Locations

Country	Name	City	State
France	CHU de Nice	Nice
France	EHPAD Valrose	Nice
France	EHPAD Villa Hélios Saint Jean	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	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.	8 weeks	No
Secondary	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	at 3, 4 and 8 weeks	No
Secondary	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	at 1, 2, 3, a weeks	No
Secondary	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	at 3, 4, 8 weeks	No
Secondary	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)	First day and 4 weeks	No