MCIMeMO-RV2NCT02176629
Usability of Virtual Reality in Subjects With Mild Cognitive Impairment or Alzheimer's Disease
A study testing Condition virtual reality (VR) then Condition classic cognitive stimulation (CCS) and Condition classic cognitive stimulation (CCS) then Condition virtual reality (VR) in people with MCI and Alzheimer's Disease, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- MCI, Alzheimer's Disease
- What is being tested?
- Condition virtual reality (VR) then Condition classic cognitive stimulation (CCS) and Condition classic cognitive stimulation (CCS) then Condition virtual reality (VR)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2014to Feb 2015
- 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 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Usability of Virtual Reality in Subjects With Mild Cognitive Impairment or Alzheimer's Disease. MeMO-RV2
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.
Read more
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.
- Conditions
- MCI, Alzheimer's Disease
- Being tested
- Condition virtual reality (VR) then Condition classic cognitive stimulation (CCS), Condition classic cognitive stimulation (CCS) then Condition virtual reality (VR)
- Keywords
- Virtual Reality, mild cognitive impairment, Alzheimer's disease
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Condition virtual reality (VR) then Condition classic cognitive stimulation (CCS)Other
Condition classic cognitive stimulation (CCS) then Condition virtual reality (VR)Other
| Study group | Role | What they receive |
|---|---|---|
| Condition virtual reality (VR) | Experimental | The subject is placed in front of a Barcotm screen capable of displaying high quality images. Receives: Other: Condition virtual reality (VR) then Condition classic cognitive stimulation (CCS) |
| Condition classic cognitive stimulation (CSC) | Active comparator | It is proposed about using the test dam Zazzo suitable for elderly. This classic test measures sustained attention. Receives: Other: Condition classic cognitive stimulation (CCS) then Condition virtual reality (VR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At the end of experience (45 min)
Secondary outcomes (1)
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.
Measured: At the end of experience (45 min)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2014 (estimated)
- Study startAug 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MCIStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe ROBERT, PUPH, Study director, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02176629
- Sponsor's protocol ID
- 14-PP-03
- Acronym
- MeMO-RV2
- Status last verified
- Aug 2015
- First submitted
- 25 Jun 2014
- Last updated
- 1 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
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
- Usability of Virtual Reality in Subjects With Mild Cognitive Impairment or Alzheimer's Disease. MeMO-RV2
- ClinicalTrials.gov ID
- NCT02176629
- Acronym / sponsor ID
- MeMO-RV2 / 14-PP-03
- Conditions
- MCI, Alzheimer's Disease
- Keywords
- Virtual Reality, mild cognitive impairment, Alzheimer's disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 27 Jun 2014 (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.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Condition virtual reality (VR) | Experimental | Other: Condition virtual reality (VR) then Condition classic cognitive stimulation (CCS)The subject is placed in front of a Barcotm screen capable of displaying high quality images. |
| Condition classic cognitive stimulation (CSC) | Active comparator | Other: Condition classic cognitive stimulation (CCS) then Condition virtual reality (VR)It is proposed about using the test dam Zazzo suitable for elderly. This classic test measures sustained attention. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female age ≥ 60 years.
- Introducing either:
- Subject undisturbed locomotion requiring the use of a walking aid.
- Score at the Mini Mental Test (MMSE) between 16 and 28.
Key exclusion criteria (7 listed)
- 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.
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 |
|---|---|---|
| Condition virtual reality (VR) then Condition classic cognitive stimulation (CCS) | Other | Condition virtual reality (VR) |
| Condition classic cognitive stimulation (CCS) then Condition virtual reality (VR) | Other | Condition classic cognitive stimulation (CSC) |
Primary outcome
Evaluate the acceptability of the RV
Time frame: At the end of experience (45 min)
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
1 secondary outcome
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).
Time frame: At the end of experience (45 min)
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, PUPH study director
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Condition virtual reality (VR) then Condition classic cognitive stimulation (CCS) and Condition classic cognitive stimulation (CCS) then Condition virtual reality (VR) in people with MCI and Alzheimer's Disease, run by Centre Hospitalier Universitaire de Nice at 1 site 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 6 inclusion and 7 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 1 site 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?
Evaluate the acceptability of the RV (time frame: At the end of experience (45 min)). 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.