VR Audiovisual Stimulation for Alzheimer's Disease

(CFS Trial)

No longer recruiting at 2 trial locations

Overseen By Sergi Navarro, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Clarity Health Technologies, Inc

Must not be taking: Monoclonal antibodies, Memantine

Disqualifiers: Seizure, Stroke, Migraine, Alcohol use, others

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

Compensation: Varies

Number of Visits: 2

Duration: 1 session

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and practicality of using a Virtual Reality (VR) headset for audiovisual stimulation (Audiovisual Stimulation VR System) in individuals with Alzheimer's and those without cognitive issues. The goal is to determine if this technology can assist with cognitive impairment related to Alzheimer's. Participants will either be cognitively healthy or have mild cognitive impairment due to Alzheimer's, and they must possess good vision and hearing without needing hearing aids. As an unphased trial, this study provides participants the chance to contribute to innovative research that could improve cognitive health.

Will I have to stop taking my current medications?

The trial requires that you have not started taking acetylcholinesterase inhibitors or Memantine in the past 30 days. If you are currently on these medications, you may need to stop or adjust them before participating.

What prior data suggests that this VR-based Audiovisual Stimulation is safe for people with Alzheimer's?

Research has shown that virtual reality (VR) technology, which includes sights and sounds, is generally safe for older adults, even those with Alzheimer's disease. In studies with similar VR treatments, participants found these methods well-tolerated, with few reports of serious side effects.

Most people find the experience comfortable, though some might experience mild discomfort, such as dizziness or eye strain. These effects are temporary and not considered dangerous. This trial aims to test the same kind of VR system, so previous findings suggest it is likely to be safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using VR audiovisual stimulation for Alzheimer's because it offers a non-invasive approach, unlike standard medications that often involve drugs like cholinesterase inhibitors or memantine. This innovative method uses immersive virtual reality to stimulate the brain, potentially improving cognitive function without the side effects associated with traditional medications. Additionally, the combination of both active and sham stimulation allows for a better understanding of the treatment's mechanism of action, paving the way for more personalized and effective interventions for those with Alzheimer's and mild cognitive impairment.

What evidence suggests that the Audiovisual Stimulation VR System is effective for Alzheimer's?

This trial will evaluate the effects of VR-based Audiovisual Stimulation on Alzheimer's disease. Studies have shown that Virtual Reality (VR) can help slow the progression of Alzheimer's disease. Research indicates that VR can enhance the emotional well-being of individuals with dementia. A review of 19 studies found that VR boosts mood and engagement in people with memory and thinking problems. Additionally, a small study confirmed that VR provides enjoyable sensory experiences important for brain health. Overall, these findings suggest that VR-based activities could benefit individuals with Alzheimer's and mild memory issues. Participants in this trial will receive both active and sham VR-based Audiovisual Stimulation to demonstrate the intervention's mechanism of action. ^{1 2 4 5 6}

Who Is on the Research Team?

Carolina Reis, PhD

Principal Investigator

Clarity Health Technologies

Are You a Good Fit for This Trial?

This trial is for individuals with mild Alzheimer's disease and healthy older adults. Specific criteria aren't provided, but typically participants must meet certain health standards and not have conditions that could interfere with the study or pose a risk.

Inclusion Criteria

I agree to wear a sensor on my wrist for the study.

Cognitively Normal Participants: Normal hearing

Cognitively Normal Participants: Native English speakers or demonstrated fluency in English (participant)

Exclusion Criteria

I have vision or hearing problems that glasses or hearing aids can't fix.

I do not have any health issues that would stop me from joining the study.

I have had a stroke but am cognitively normal.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive audiovisual stimulation via a VR headset in one experimental session

1 session

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness immediately after the intervention

Immediately after intervention

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Audiovisual Stimulation VR System

Trial Overview The study tests if it's safe and feasible to use a VR headset to provide audiovisual stimulation to people with mild Alzheimer's and healthy aging individuals. It’s single-blind, meaning only the participants won’t know if they’re getting the real treatment or a sham (fake) version.

How Is the Trial Designed?

Group I: Active and Sham Audiovisual Stimulation (Mild AD and MCI due to AD): Experimental Treatment 1 Intervention

Both active and sham stimulation conditions will be delivered to 25 cognitively impaired participants to demonstrate the mechanism of action of the intervention.

Group II: Active and Sham Audiovisual Stimulation (Cognitively Healthy): Experimental Treatment 1 Intervention

Both active and sham stimulation conditions will be delivered to 25 healthy participants to demonstrate the mechanism of action of the intervention.

Who Is Running the Clinical Trial?

Clarity Health Technologies, Inc

Lead Sponsor

Trials

1

Recruited

60+

SymmetryScience Group, Inc.

Industry Sponsor

Trials

2

Recruited

150+

Published Research Related to This Trial

The interactive multimedia internet-based system (IMIS) significantly improved cognitive function in patients with Alzheimer's disease when combined with an integrated psychostimulation program (IPP), as shown by sustained improvements in the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) and Mini-Mental State Examination (MMSE) over 24 weeks.

Patients receiving only the IPP showed better outcomes than those on cholinesterase inhibitors alone, but the cognitive benefits from the IMIS were greater and maintained longer, highlighting its potential as an effective cognitive stimulation tool for Alzheimer's patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised pilot study to assess the efficacy of an interactive, multimedia tool of cognitive stimulation in Alzheimer's disease. Tárraga, L., Boada, M., Modinos, G., et al.[2022]

Audio Visual Stimulation (AVS) is a non-drug intervention that has shown effectiveness in enhancing performance and managing symptoms, with potential new applications for improving sleep and reducing pain.

Despite its clinical use, there is a need for more standardized research methods and clearer definitions in AVS studies to better evaluate its clinical outcomes and mechanisms of action.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Open-Loop Audio-Visual Stimulation (AVS): A Useful Tool for Management of Insomnia? Tang, HY., Riegel, B., McCurry, SM., et al.[2018]

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]

Over 80% of older adults, both with and without Alzheimer's disease, successfully completed a virtual reality (VR) navigation task, indicating that VR can be a feasible tool for cognitive assessment in this population.

While most participants tolerated the VR experience well, only 60% completed the eye tracking component, with calibration issues being a common barrier, particularly among those with Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Feasibility of Using Virtual Reality and Eye Tracking in Research With Older Adults With and Without Alzheimer's Disease. Davis, R.[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]

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]

A case study of a man with early Alzheimer's disease showed that he could successfully learn to navigate in a virtual reality environment, indicating potential for cognitive training in AD.

Feedback from his caregiver suggested that this training not only improved his navigation skills in the virtual setting but also translated to real-life benefits, such as better driving skills and overall cognitive improvement at home.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurocognitive Treatment for a Patient with Alzheimer's Disease Using a Virtual Reality Navigational Environment. White, PJ., Moussavi, Z.[2020]

Video prompting was found to be effective in helping individuals with mild and moderate Alzheimer's disease perform daily activities, showing similar effectiveness to verbal instructions and static pictorial cues.

Social validation assessments indicated that observers rated the performance of patients using video prompting more favorably compared to the other strategies, suggesting a preference for this method in supporting daily activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Video prompting versus other instruction strategies for persons with Alzheimer's disease. Perilli, V., Lancioni, GE., Hoogeveen, F., et al.[2015]

A virtual reality driving simulator (VRDS) was tested on 11 participants with varying levels of dementia over 10 sessions, showing a significant 44.4% improvement in spatial cognition as measured by the Morris Water test after the intervention.

Participants not only improved their spatial skills but also progressed to more challenging levels of the game and reported better mood, suggesting that regular use of the VRDS could be beneficial for older adults with cognitive impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Practicing with a Virtual Reality Driving Simulator Improve Spatial Cognition in Older Adults? A Pilot Study. Masoumzadeh, S., Moussavi, Z.[2022]

Current virtual reality (VR) technologies for Alzheimer's disease applications are underutilizing immersive features, often relying on conventional 2D displays instead of fully engaging 3D environments.

To enhance the effectiveness of VR in diagnosing and training for Alzheimer's, improvements such as advanced head-mounted displays, multi-sensory interactions, and neuro-physiological feedback are recommended, along with making these technologies accessible for home and nursing home use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A succinct overview of virtual reality technology use in Alzheimer's disease. García-Betances, RI., Arredondo Waldmeyer, MT., Fico, G., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06234930

The Feasibility, Safety and Tolerability of VR-based ... Recent literature suggests that when applied chronically, audiovisual stimulation may slow down the progression of Alzheimer's disease (AD). In contrast to ...

2. trialx.com trialx.com/clinical-trials/listings/283431/the-feasibility-safety-and-tolerability-of-vr-based-audiovisual-stimulation/

The Feasibility, Safety and Tolerability of VR-based ... Recent literature suggests that when applied chronically, audiovisual stimulation may slow down the progression of Alzheimer's disease (AD). In contrast to ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6626425/

The effectiveness of virtual reality for people with mild ... The aim of this study was to synthesize the effects of VR interventions for people with mild cognitive impairment (MCI) or dementia.

4. withpower.com withpower.com/trial/phase-healthy-aging-11-2023-dc429

VR Audiovisual Stimulation for Alzheimer's Disease · Info ... A scoping review of 19 studies found that Virtual Reality (VR) technologies can positively impact the emotional wellbeing of persons with dementia, with ...

5. nature.com nature.com/articles/s41598-025-13725-6

VR-based gamma sensory stimulation: a pilot feasibility study The findings of this study validate VR as a scalable tool for delivering engaging and cognitively relevant GSS, paving the way for personalized ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12468393/

Effects of Cognitive Training with Virtual Reality in Older Adults Interventions varied in duration from 4 to 36 sessions, targeting domains such as memory, executive function, attention, and global cognition.