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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how Virtual Reality (VR) therapy at home might assist people with dementia and their caregivers. It aims to determine if VR can ease behavioral symptoms like mood swings and agitation while providing caregivers with opportunities to relax and reduce stress. Participants will try various VR experiences using immersive VR therapy in a head-mounted device (HMD) to identify the most effective options. The trial seeks individuals with dementia who live at home with a family caregiver and are 65 or older. As an unphased trial, this study offers a unique opportunity to explore innovative VR therapy and contribute to groundbreaking research.

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 prior data suggests that this VR therapy is safe for individuals with dementia?

Research shows that virtual reality (VR) therapy is generally safe for people with dementia. Studies have found that VR can enhance emotional and social well-being without causing harm. For instance, a review found that VR had a positive or neutral effect on mood and social interactions in people with dementia, meaning most felt better or the same after VR sessions.

Another study highlighted that VR sessions are often passive, requiring little movement or interaction, which can be easier for older adults. Importantly, these studies reported no major negative side effects, suggesting that VR therapy is well-tolerated by people with dementia.

In conclusion, while more research is always beneficial, current evidence supports the safety of VR therapy for individuals with dementia. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about VR therapy for dementia because it's a novel, immersive approach that engages patients in a completely new way. Unlike traditional treatments that typically involve medications aiming to manage symptoms, VR therapy uses a head-mounted device to create an interactive environment, potentially improving cognitive function and mood. This method allows caregivers some respite while ensuring patients receive engaging, supervised therapy at home. The unique aspect of this trial is its focus on both solo and social use of VR, which could reveal how different interactions impact the patient's experience and outcomes.

What evidence suggests that VR therapy is effective for dementia?

Research shows that virtual reality (VR) therapy can enhance cognitive and physical abilities in people with Alzheimer's and dementia. Studies have found that VR experiences can boost mood and help maintain cognitive skills during treatment. In this trial, participants will be divided into two groups: one group will start VR therapy with only the caregiver present, while the other will begin with a research assistant present. VR therapy is safe and enjoyable, offering a satisfying experience for older adults with memory and cognitive challenges. Although improvements in quality of life are not as pronounced, the therapy positively affects overall well-being. Overall, VR therapy is a promising tool for managing dementia symptoms and enhancing the lives of both patients and caregivers. ^{2 5 6 7 8}

Are You a Good Fit for This Trial?

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.

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

People with a history of seizures or epilepsy

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9681900/

Effect of virtual reality exercise on interventions for patients ... The main finding was that VR interventions could help improve cognitive and physical balance in patients with AD.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S156816372500131X

Effectiveness of virtual reality interventions on quality of life ... VR interventions may benefit cognitive function, physical function, and, to a lesser extent, quality of life in older people with AD.

3. nature.com nature.com/articles/s41598-025-14624-6

A smart secure virtual reality immersive application for ... While VR therapy has shown a minimal potential in enhancing cognition, they are often passive, relying on generic environments that provide ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9361147/

The Long-term Effects of Immersive Virtual Reality ... Immersive VR reminiscence can improve mood and preserve cognitive function in elderly patients with dementia during the period of the intervention.

5. jmir.org jmir.org/2024/1/e53348/PDF

The Effects of Virtual Reality–Based Reminiscence ... The results indicated that VR-RTs are safe, engaging, acceptable, and satisfying for older adults with cognitive impairment. In VR scenarios, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8743938/

Virtual reality to promote wellbeing in persons with dementia This review found that VR represents a promising tool for promoting wellbeing in PwD, with positive or neutral impact reported on emotional, social, and ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40835985/

A smart secure virtual reality immersive application for ... The security measures include access controls, encryption and continuous monitoring of cloud patient data. The initial study has been promising ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04988360

Study to Evaluate VR-therapy for PwD Living at Home The investigators are designing and rigorously evaluating the first Virtual Reality-therapy program for people with dementia (PwD) living at home.