Advance DementiaNCT06419257
Investigating the Efficacy of an Augmented Virtual Reality Driving Simulator on Institutionalized Dementia Patients
A study testing VRDS in people with Advance Dementia, run by University of Manitoba at 1 site in Canada.
Trial summary
The improvement in health and welfare in modern society has led to an increase in life expectancy. Alternatively, the longer one lives, the more likely to experience deterioration in memory, cognitive ability, and executive function skills in our brains. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Advance Dementia
- What is being tested?
- VRDS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 2 Jan 2024to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Living in a dementia care unit of Riverview Health Center
- Being mobile and able to see.
Who cannot join
- Residents with significant mobility issues (wheelchair users) and those with significant visual impairment will be excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Saber Mirmiran, M.Sc. contact
Canada1 site, 1 recruiting
- Recruiting
Riverview Health Center
Winnipeg, Manitoba, R3L 2P4
Zahra Moussavi, Ph.D., 204-478-6163, zahra.moussavi@umanitoba.ca
Saber Mirmiran, M.Sc., mirmiras@myumanitoba.ca
About this study
Official title: Investigating the Efficacy of an Augmented Virtual Reality Driving Simulator (VRDS) on Institutionalized Dementia Patients
The improvement in health and welfare in modern society has led to an increase in life expectancy. Alternatively, the longer one lives, the more likely to experience deterioration in memory, cognitive ability, and executive function skills in our brains. While some cognitive impairments can be typical results of normal aging, a decline in spatial cognition can be a sign of dementia, especially Alzheimer's disease (AD). Based on the neuroplasticity of the brain even at old ages, there are some hopes to combat dementia by repeated use of cognitive exercises in the form of a serious game designed for older adults. A popular new technology to be used to design serious games is virtual reality (VR) designs. Aside from the gaming applications, the focus of VR experiments in medicine and neuroscience is to simulate a naturalistic environment to investigate brain function and/or use it for cognitive training.
A virtual reality driving simulator (VRDS) has been developed by our team that is proposed to be installed in an existing car model at Riverview Health Center (RHC) dementia units. The VRDS has different levels of difficulty so that it can be utilized by people with different levels of cognitive impairments. However, in this study, the users will probably use only its level 1. The aim is to investigate the efficacy of the VRDS amongst institutionalized Alzheimer's/dementia patients, who are not capable of performing standard assessments. The goal is mainly to improve their mood and quality of life as many of these patients miss driving. Thus, their plausible mood change are assessed by asking the dementia unit nurses to share their observations of the patients in relation to VRDS usage; it will be a free-format anecdotal observation. In addition, while these patients are not expected to show any significant learning, playing this VRDS may improve patients' implicit memory; which can be observed by how well or poor they drive the simulated car; for example, how many times they crash to the curb or how many times they hit an animal, or how many times they ignore the red traffic light, etc.; these are reflected in the game's score.
It is anticipated that this VRDS will have an overall positive effect on users' moods, and also it may result in an implicit memory improvement.
Read the detailed description
The only research instrument is the designed VRDS. Virtual Reality Driving Simulator (VRDS) Experiment The VRDS is a serious game that features three levels of difficulty and routes through a naturalistic country road. As the game progresses in each level, the route will contain various intersections. One intersection is located on the first level, while two and three intersections are located on the second and third levels. A number of traffic elements are placed along the road. Every intersection has a traffic light. There are stop signs at a few points throughout each level (one stop sign for each of the first two levels and two stop signs for the final level). In addition, an upcoming vehicle is occasionally placed in the opposite lane and during the initial stages of each level, the sudden appearance of a rural animal is simulated.
In this study, our target users are advanced stage 3 and 4 dementia (in particular Alzheimer's disease) patients who are institutionalized. Therefore, the VRDS has been designed in a way that when a participant starts using it, the game will begin from level 1. In case they successfully complete the level, then they will automatically proceed to level 2. If the game remains idle, then it will be reset to level 1. There will be no written instructions but an audio messages is played as the warning (e.g. passing a red light without stopping) and encouraging messages when they reach a target on the road.
User-specific log files are created for each training trial the user plays; they are created using an interactive input field before the training begins. Our analysis of the logged file lets us know for example whether the users have stopped at traffic signals and stop signs in a timely manner, or they have crashed to the curb, or haven't stopped when an animal jumps to the road, etc.
The VRDS will be installed in the existing car model in A-B dementia units of the RHC. The steering wheel and accelerating pedal of the car will be replaced with the steering wheel and pedals that are used as input controllers of the VRDS game. The VRDS screen on the laptop will be projected to the actual front window of the car.
In our experience, patients with advanced-stage dementia do not feel motion sickness; however, it is still possible for a participant to feel motion sickness, in that case, the research assistant next to the participant will stop the program and help the participant to get out of the car and back to their room.
- Conditions
- Advance Dementia
- Being tested
- VRDS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VRDSDevice
VRDS is an augmented virtual reality driving simulator.
| Study group | Role | What they receive |
|---|---|---|
| VRDS users | Experimental | Individuals who would use the VRDS Receives: Device: VRDS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nurses overall observations of the study participants on a scale of -1, 0 and 1 for worse, no change and improved, respectively.
a custom made questionnaire for interview of the nurses of the participants
Measured: every week for a maximum of 52 weeks
Secondary outcomes (1)
The Game's score through the period of the study on a value between 0 to 100 for the minimum and maximum score in the game.
The VRDS logs all the information on how the game is played. Those information is used to give an overall score representing the performance of the user.
Measured: every week for a maximum of 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start2 Jan 2024
- Primary completionMay 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advance DementiaStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe 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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zahra Moussavi, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06419257
- Sponsor's protocol ID
- HS23059 (B2023:059)
- Status last verified
- Sep 2026
- First submitted
- 1 Aug 2023
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Efficacy of an Augmented Virtual Reality Driving Simulator (VRDS) on Institutionalized Dementia Patients
- ClinicalTrials.gov ID
- NCT06419257
- Acronym / sponsor ID
- HS23059 (B2023:059)
- Conditions
- Advance Dementia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 17 May 2024 (actual)
- 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.
The improvement in health and welfare in modern society has led to an increase in life expectancy. Alternatively, the longer one lives, the more likely to experience deterioration in memory, cognitive ability, and executive function skills in our brains. While some cognitive impairments can be typical results of normal aging, a decline in spatial cognition can be a sign of dementia, especially Alzheimer's disease (AD). Based on the neuroplasticity of the brain even at old ages, there are some hopes to combat dementia by repeated use of cognitive exercises in the form of a serious game designed for older adults. A popular new technology to be used to design serious games is virtual reality (VR) designs. Aside from the gaming applications, the focus of VR experiments in medicine and neuroscience is to simulate a naturalistic environment to investigate brain function and/or use it for cognitive training.
A virtual reality driving simulator (VRDS) has been developed by our team that is proposed to be installed in an existing car model at Riverview Health Center (RHC) dementia units. The VRDS has different levels of difficulty so that it can be utilized by people with different levels of cognitive impairments. However, in this study, the users will probably use only its level 1. The aim is to investigate the efficacy of the VRDS amongst institutionalized Alzheimer's/dementia patients, who are not capable of performing standard assessments. The goal is mainly to improve their mood and quality of life as many of these patients miss driving. Thus, their plausible mood change are assessed by asking the dementia unit nurses to share their observations of the patients in relation to VRDS usage; it will be a free-format anecdotal observation. In addition, while these patients are not expected to show any significant learning, playing this VRDS may improve patients' implicit memory; which can be observed by how well or poor they drive the simulated car; for example, how many times they crash to the curb or how many times they hit an animal, or how many times they ignore the red traffic light, etc.; these are reflected in the game's score.
It is anticipated that this VRDS will have an overall positive effect on users' moods, and also it may result in an implicit memory improvement.
Detailed description
The only research instrument is the designed VRDS. Virtual Reality Driving Simulator (VRDS) Experiment The VRDS is a serious game that features three levels of difficulty and routes through a naturalistic country road. As the game progresses in each level, the route will contain various intersections. One intersection is located on the first level, while two and three intersections are located on the second and third levels. A number of traffic elements are placed along the road. Every intersection has a traffic light. There are stop signs at a few points throughout each level (one stop sign for each of the first two levels and two stop signs for the final level). In addition, an upcoming vehicle is occasionally placed in the opposite lane and during the initial stages of each level, the sudden appearance of a rural animal is simulated.
In this study, our target users are advanced stage 3 and 4 dementia (in particular Alzheimer's disease) patients who are institutionalized. Therefore, the VRDS has been designed in a way that when a participant starts using it, the game will begin from level 1. In case they successfully complete the level, then they will automatically proceed to level 2. If the game remains idle, then it will be reset to level 1. There will be no written instructions but an audio messages is played as the warning (e.g. passing a red light without stopping) and encouraging messages when they reach a target on the road.
User-specific log files are created for each training trial the user plays; they are created using an interactive input field before the training begins. Our analysis of the logged file lets us know for example whether the users have stopped at traffic signals and stop signs in a timely manner, or they have crashed to the curb, or haven't stopped when an animal jumps to the road, etc.
The VRDS will be installed in the existing car model in A-B dementia units of the RHC. The steering wheel and accelerating pedal of the car will be replaced with the steering wheel and pedals that are used as input controllers of the VRDS game. The VRDS screen on the laptop will be projected to the actual front window of the car.
In our experience, patients with advanced-stage dementia do not feel motion sickness; however, it is still possible for a participant to feel motion sickness, in that case, the research assistant next to the participant will stop the program and help the participant to get out of the car and back to their room.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VRDS users | Experimental | Device: VRDSIndividuals who would use the VRDS |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Living in a dementia care unit of Riverview Health Center
- Being mobile and able to see.
Key exclusion criteria (1 listed)
- Residents with significant mobility issues (wheelchair users) and those with significant visual impairment will be excluded.
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 |
|---|---|---|
| VRDSVRDS is an augmented virtual reality driving simulator. | Device | VRDS users |
Primary outcome
Nurses overall observations of the study participants on a scale of -1, 0 and 1 for worse, no change and improved, respectively.
Time frame: every week for a maximum of 52 weeks
a custom made questionnaire for interview of the nurses of the participants
1 secondary outcome
The Game's score through the period of the study on a value between 0 to 100 for the minimum and maximum score in the game.
Time frame: every week for a maximum of 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
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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.
Saber Mirmiran, M.Sc. contact
Zahra Moussavi principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VRDS in people with Advance Dementia, run by University of Manitoba at 1 site in Canada.
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 2 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: looking for participants now, as of the sponsor's last update on 2 Oct 2026. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zahra Moussavi, Ph.D. (2044747023, Zahra.Moussavi@umanitoba.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nurses overall observations of the study participants on a scale of -1, 0 and 1 for worse, no change and improved, respectively. (time frame: every week for a maximum of 52 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 2 Oct 2026.