VR Therapy for Dementia

(VR&R Trial)

Recruiting at 7 trial locations

Overseen By Lora Appel, PhD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Seizures, Pacemaker, Head trauma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

50 Participants Needed

Trial Summary

Do I need to stop my current medications for the VR Therapy for Dementia trial?

The trial protocol does not specify whether you need to stop taking your current medications. It seems likely that you can continue your medications, but please confirm with the trial organizers.

What data supports the effectiveness of the treatment Immersive VR Therapy in Head-Mounted Device (HMD) for dementia?

Research shows that virtual reality (VR) can improve emotional wellbeing and reduce apathy in people with dementia, making it a promising tool for enhancing quality of life. Studies have found VR to be safe, enjoyable, and engaging, although its impact on physical aspects like balance and mobility is less clear. ^{1 2 3 4 5}

Is VR therapy safe for people with dementia?

Research shows that VR therapy is generally safe for people with dementia, with studies reporting it as a well-tolerated and enjoyable experience. Some minor issues like eyestrain and mild anxiety were noted, but no significant negative effects were found. ^{1 2 4 6 7}

How is Immersive VR Therapy in Head-Mounted Device (HMD) different from other treatments for dementia?

Immersive VR Therapy using a head-mounted device is unique because it provides a non-drug approach to dementia care, focusing on enhancing emotional well-being and engagement through virtual environments. Unlike traditional treatments, it allows people with dementia to interact with realistic simulations, which can promote reminiscence and improve mood without significant side effects. ^{1 4 7 8 9}

What is the purpose of this trial?

The goal of this interventional trial is to learn about how immersive Virtual Reality (VR) therapy can be used at home by individuals with dementia, with assistance from their informal (e.g., friend/family) caregivers. The main question it aims to answer are: 1. Can caregivers receive quality respite time by using VR-therapy at home with their loved ones with dementia? Does this intervention reduce feelings of burden and improve well-being and resilience for caregivers? 2. Does VR-therapy help to manage behavioural and psychological symptoms (e.g., mood, apathy, agitation) and improve quality of life for individuals with dementia? 3. What types of VR "medium" (passive or cooperative) are most effective for achieving the above objectives? Participant pairs will be asked to: * Take part in an initial at-home VR technology training session and complete a series of brief questionnaires (e.g., health history/technology use, well-being/quality of life, symptoms of dementia) * Use "VR\&R" (VR Rest \& Relaxation Therapy) for a period of 4 weeks (30 minute sessions, desired frequency), and answer a brief set of questions after each VR\&R session * Provide feedback on the VR\&R intervention in semi-structured interview with the researcher and answer additional questionnaires at a 2-week follow-up During VR\&R sessions, participants with dementia will have the opportunity to choose to watch (1) immersive 360-degree videos (e.g., of a live performance, or beach) on their own and (2) experience the same VR videos together with a researcher. Caregivers will be asked to assist their loved one with dementia to use VR\&R by helping to put on the VR headset, selecting a VR experience through a user-friendly application, and remaining nearby to supervise and provide assistance as needed. During VR\&R sessions, caregivers may use this time to take a personal break or complete short tasks (e.g., make a cup of coffee, have an uninterrupted phone call).

Eligibility Criteria

This trial is for people with dementia aged 65 or older living at home with a family caregiver who can access the internet. Caregivers should be able to speak and understand English, provide consent, and assist their loved one. Excluded are those with certain legal guardianships, language barriers, pacemakers, blindness, open facial wounds (except sutured lacerations), seizure history, recent head trauma or stroke, unsafe cervical conditions for VR use, or alcohol-related dementia.

Inclusion Criteria

I am a primary caregiver with internet access and a device for the study.

People diagnosed with dementia

I am 65 or older with dementia.

Exclusion Criteria

I am legally blind.

People with alcohol-related dementia/Korsakoff syndrome

I do not have any open wounds on my face, except for stitched cuts.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Training

Participants take part in an initial at-home VR technology training session and complete a series of brief questionnaires

1 week

1 visit (in-person)

VR Therapy

Participants use VR&R therapy for a period of 4 weeks, with sessions lasting 30 minutes each

4 weeks

At-home sessions

Follow-up

Participants provide feedback on the VR&R intervention in semi-structured interviews and answer additional questionnaires

2 weeks

1 visit (in-person or virtual)

Treatment Details

Interventions

• Immersive VR Therapy in Head-Mounted Device (HMD)

Trial Overview The study tests if immersive VR therapy helps caregivers get respite time and improves well-being while managing symptoms of dementia like mood swings and agitation in patients. It explores which type of VR content—passive videos, interactive games or cooperative experiences—is most effective over three weeks of sessions.

Participant Groups

Group I: VR&R Therapy - Solo First Experimental Treatment 2 Interventions

Recruited dyads will include one person diagnosed with dementia and their caregiver (e.g., family/friend). The caregiver will assist their loved ones with dementia to use VR-therapy at home. Caregivers may use the time while their loved ones are engaged for respite, remaining nearby to supervise and assist. For the first two weeks, only the caregiver will be present to use VR with the person with dementia. For the following two weeks, a research assistant will be present to use VR with the person with dementia.

Group II: VR&R Therapy - Social First Experimental Treatment 2 Interventions

Recruited dyads will include one person diagnosed with dementia and their caregiver (e.g., family/friend). The caregiver will assist their loved ones with dementia to use VR-therapy at home. Caregivers may use the time while their loved ones are engaged for respite, remaining nearby to supervise and assist. For the first two weeks, a research assistant will be present to use VR with the person with dementia. For the following two weeks, only the caregiver will be present.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Centre for Aging and Brain Health Innovation

Collaborator

Trials

16

Recruited

5,200+

Ontario AHSC AFP Innovation Fund

Collaborator

Trials

1

Recruited

50+

Findings from Research

A scoping review of 19 studies found that Virtual Reality (VR) technologies can positively impact the emotional wellbeing of persons with dementia, with emotional outcomes being the primary focus in 89.5% of the studies.

While VR shows promise in enhancing quality of life for people with dementia, there is a need for further exploration of its effects on social engagement and personhood, as well as customization of VR tools for different sub-groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality to promote wellbeing in persons with dementia: A scoping review. Appel, L., Ali, S., Narag, T., et al.[2022]

The Virtual Reality Forest (VRF) experience positively impacted the mood and engagement of 10 residents with dementia, leading to increased pleasure and alertness during the session.

Despite the positive effects, residents also reported higher levels of fear and anxiety compared to a normative sample, indicating that while VR can enhance quality of life, it may also evoke some negative emotions that need to be addressed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a Virtual Reality Forest on People With Dementia: A Mixed Methods Pilot Study. Moyle, W., Jones, C., Dwan, T., et al.[2019]

Virtual reality (VR) intervention significantly improves cognitive function in older adults with mild cognitive impairment or dementia, showing moderate positive effects on overall cognition, attention, memory, and global cognition based on a meta-analysis of 11 studies with 359 participants.

VR intervention also positively impacts motor function, particularly balance, but does not show significant improvements in visuospatial ability or gait performance, indicating its potential as a beneficial non-drug treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Virtual Reality Intervention on Cognition and Motor Function in Older Adults With Mild Cognitive Impairment or Dementia: A Systematic Review and Meta-Analysis. Zhu, S., Sui, Y., Shen, Y., et al.[2021]

The study involving six persons with dementia showed that they could effectively interact with a virtual reality environment, indicating that VR can be a useful tool for assessing functional behavior in a realistic setting.

Participants did not experience significant simulator sickness or negative impacts on their psychological and physical well-being, suggesting that VR technology is safe for use among individuals with dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a virtual reality-based methodology for people with dementia: a feasibility study. Flynn, D., van Schaik, P., Blackman, T., et al.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Virtual reality to promote wellbeing in persons with dementia: A scoping review. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Two-week virtual reality training for dementia: Single case feasibility study. [2014]

3. England pubmed.ncbi.nlm.nih.gov

The effectiveness of nursing interventions for elderly dementia patients based on virtual reality technology: A systematic review and meta-analysis. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of a Virtual Reality Forest on People With Dementia: A Mixed Methods Pilot Study. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Preliminary Research: Virtual Reality in Residential Aged Care to Reduce Apathy and Improve Mood. [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of Virtual Reality Intervention on Cognition and Motor Function in Older Adults With Mild Cognitive Impairment or Dementia: A Systematic Review and Meta-Analysis. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Promoting Reminiscences with Virtual Reality Headsets: A Pilot Study with People with Dementia. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Developing a virtual reality-based methodology for people with dementia: a feasibility study. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Virtual Reality for Therapeutic Recreation in Dementia Hospice Care: A Feasibility Study. [2022]