Alzheimer's DiseaseVERVENCT01798199
Vanquishing Apathy Through E-inclusion Using Realistic Virtual Environment Project
A study testing The training by Verve System in people with Alzheimer's Disease, run by Centre Hospitalier Universitaire de Nice at 3 sites in France.
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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- The training by Verve System
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 3 sitesFrance
- Study dates
- May 2013to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHU de Nice
Nice, 06000
EHPAD Valrose
Nice, 06000
EHPAD Villa Hélios Saint Jean
Nice, 06000
About this study
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)
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.
Read more
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.
- Conditions
- Alzheimer's Disease
- Being tested
- The training by Verve System
- Keywords
- Alzheimer, virtual reality system, Alzheimer's disease related conditions
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The training by Verve SystemOther
| Study group | Role | What they receive |
|---|---|---|
| Alzheimer disease | Experimental | Not described Receives: Other: The training by Verve System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (4)
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
Measured: at 3, 4 and 8 weeks
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
Measured: at 1, 2, 3, a weeks
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
Measured: at 3, 4, 8 weeks
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)
Measured: First day and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2013 (estimated)
- Study startMay 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe ROBERT, PU-PH, Study director, Centre Hospitalier Universitaire de NiceRenaud DAVID, PH, Study chair, Centre Hospitalier Universitaire de NiceGuillaume SACCO, PH, Study chair, Centre Hospitalier Universitaire de NiceJean Michel TURPIN, PH, Study chair, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01798199
- Sponsor's protocol ID
- 12-PP-04
- Acronym
- VERVE
- Status last verified
- Aug 2015
- First submitted
- 21 Nov 2012
- Last updated
- 1 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01798199
- Acronym / sponsor ID
- VERVE / 12-PP-04
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer, virtual reality system, Alzheimer's disease related conditions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 25 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alzheimer disease | Experimental | Other: The training by Verve System |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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);
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The training by Verve System | Other | Alzheimer disease |
Primary outcome
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.
4 secondary outcomes
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 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 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 cognitive impact of the light VERVE setting. Using Stroop, TMT, VAT and functional task (IADL)
Time frame: First day and 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe ROBERT, PU-PH study director
Centre Hospitalier Universitaire de Nice
Renaud DAVID, PH study chair
Centre Hospitalier Universitaire de Nice
Guillaume SACCO, PH study chair
Centre Hospitalier Universitaire de Nice
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The training by Verve System in people with Alzheimer's Disease, run by Centre Hospitalier Universitaire de Nice at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the participants and careers acceptability (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2015.