VR Audiovisual Stimulation for Alzheimer's Disease
(CFS Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Clarity Health Technologies, Inc
Must not be taking: Monoclonal antibodies, Memantine
Disqualifiers: Seizure, Stroke, Migraine, Alcohol use, others
No Placebo Group
Trial Summary
What is the purpose of this trial?
This is a single-blind, sham-controlled, clinical trial that aims to evaluate the safety, tolerability, and feasibility of delivering audiovisual stimulation via a Virtual Reality (VR) headset to people cognitively impaired due to Alzheimer's and cognitively unimpaired people.
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 data supports the effectiveness of the treatment Audiovisual Stimulation VR System for Alzheimer's Disease?
Research shows that virtual reality (VR) treatments can help improve cognitive functions like memory and attention in people with dementia, including Alzheimer's. A study found that VR-based navigation training improved real-life cognitive skills, and another review highlighted VR's positive impact on emotional and social wellbeing.12345
Is VR audiovisual stimulation safe for humans?
Research shows that virtual reality (VR) technology, including audiovisual stimulation, is generally safe for older adults, including those with Alzheimer's disease. Most participants in studies could complete VR tasks without significant side effects, and there were no major increases in symptoms like simulator sickness.12678
How is the VR Audiovisual Stimulation treatment different from other Alzheimer's treatments?
The VR Audiovisual Stimulation treatment is unique because it uses immersive virtual reality technology to engage patients in cognitive training, which can improve navigation skills and cognitive function in daily life. Unlike traditional treatments, this approach leverages interactive and immersive environments to potentially enhance memory and attention in Alzheimer's patients.125910
Eligibility Criteria
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)
See 14 more
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.
See 21 more
Trial Timeline
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)
Treatment Details
Interventions
- Audiovisual Stimulation VR System (Behavioural Intervention)
Trial OverviewThe 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.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Active and Sham Audiovisual Stimulation (Mild AD and MCI due to AD):Experimental Treatment1 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 Treatment1 Intervention
Both active and sham stimulation conditions will be delivered to 25 healthy participants to demonstrate the mechanism of action of the intervention.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Lakeview Institute of Clinical Research LLCLeesburg, FL
Urban Co-WorksScranton, PA
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Who Is Running the Clinical Trial?
Clarity Health Technologies, IncLead Sponsor
SymmetryScience Group, Inc.Industry Sponsor
References
A succinct overview of virtual reality technology use in Alzheimer's disease. [2022]We provide a brief review and appraisal of recent and current virtual reality (VR) technology for Alzheimer's disease (AD) applications. We categorize them according to their intended purpose (e.g., diagnosis, patient cognitive training, caregivers' education, etc.), focus feature (e.g., spatial impairment, memory deficit, etc.), methodology employed (e.g., tasks, games, etc.), immersion level, and passive or active interaction. Critical assessment indicates that most of them do not yet take full advantage of virtual environments with high levels of immersion and interaction. Many still rely on conventional 2D graphic displays to create non-immersive or semi-immersive VR scenarios. Important improvements are needed to make VR a better and more versatile assessment and training tool for AD. The use of the latest display technologies available, such as emerging head-mounted displays and 3D smart TV technologies, together with realistic multi-sensorial interaction devices, and neuro-physiological feedback capacity, are some of the most beneficial improvements this mini-review suggests. Additionally, it would be desirable that such VR applications for AD be easily and affordably transferable to in-home and nursing home environments.
Neurocognitive Treatment for a Patient with Alzheimer's Disease Using a Virtual Reality Navigational Environment. [2020]In this case study, a man at the onset of Alzheimer's disease (AD) was enrolled in a cognitive treatment program based upon spatial navigation in a virtual reality (VR) environment. We trained him to navigate to targets in a symmetric, landmark-less virtual building. Our research goals were to determine whether an individual with AD could learn to navigate in a simple VR navigation (VRN) environment and whether that training could also bring real-life cognitive benefits. The results show that our participant learned to perfectly navigate to desired targets in the VRN environment over the course of the training program. Furthermore, subjective feedback from his primary caregiver (his wife) indicated that his skill at navigating while driving improved noticeably and that he enjoyed cognitive improvement in his daily life at home. These results suggest that VRN treatments might benefit other people with AD.
Virtual reality to promote wellbeing in persons with dementia: A scoping review. [2022]Virtual Reality (VR) technologies have increasingly been considered potentially valuable tools in dementia-related research and could serve as non-pharmacological therapy to improve quality of life (QoL) and wellbeing for persons with dementia (PwD). In this scoping review, we summarize peer-reviewed articles published up to Jan-21, 2021, on the use of VR to promote wellbeing in PwD. Eighteen manuscripts (reporting on 19 studies) met the inclusion criteria, with a majority published in the past 2 years. Two reviewers independently coded the articles regarding A) intended clinical outcomes and effectiveness of the interventions, B) study sample (characteristics of the participants), C) intervention administration (by whom, what setting), D) experimental methods (design/instruments), and E) technical properties of the VR-systems (hardware/devices and software/content). Emotional outcomes were by far the most common objectives of the interventions, reported in seventeen (89.5%) of the included articles. Outcomes addressing social engagement and personhood in PwD have not been thoroughly explored using VR. Based on the positive impact of VR, future opportunities lie in identifying special features and customization of the hardware/software to afford the most benefit to different sub-groups of the target population. Overall, this review found that VR represents a promising tool for promoting wellbeing in PwD, with positive or neutral impact reported on emotional, social, and functional aspects of wellbeing.
Does Practicing with a Virtual Reality Driving Simulator Improve Spatial Cognition in Older Adults? A Pilot Study. [2022]Memory, cognition, executive functioning, and spatial cognition loss are prevalent in the normal aging process, but these impairments are observed more extensively in individuals with dementia, specifically Alzheimer's disease. To improve the impaired functions, serious games targeting the lost functions are commonly developed and used in training programs. In this study, we designed a virtual reality driving simulator (VRDS) as a serious game with different difficulty levels for improving the spatial cognition; we evaluated it on 11 participants with different levels of dementia for two weeks, every day except weekends (10 sessions of practice in total) and 30 min/day. We assessed the participants' spatial cognition before and after the intervention by an independent assessment (the VR replica of Morris Water test) and also by their performance playing the VRDS during the intervention. We also assessed the participants' mood by a standard depression scale as well as their plausible experience of simulation sickness. The results showed significant improvement in Morris water test. The participants' normalized correct trajectory (to find the target) was improved significantly by 44.4% at post-intervention with respect to baseline. Furthermore, on average, the participants progressed to higher (more challenging) levels of the game, and their spatial learning score increased throughout the sessions. Their mood also showed improvement with respect to baseline. Overall, the results hold promise for the designed VRDS as a mood-lifting and enhancing spatial skills serious game for older adults if it is played regularly. Trial Registry name: Investigating the Effect of Training with a Virtual Reality Driving Simulator URL: https://clinicaltrials.gov/ct2/show/NCT04074655 Clinical Trials.gov ID: NCT04074655.
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]Background: Virtual reality (VR) intervention is an innovative and efficient rehabilitative tool for patients affected by stroke, Parkinson's disease, and other neurological disorders. This meta-analysis aims to evaluate the effects of VR intervention on cognition and motor function in older adults with mild cognitive impairment or dementia. Methods: Seven databases were systematically searched for relevant articles published from inception to April 2020. Randomized controlled trials examining VR intervention in adults with mild cognitive impairment or dementia aged >60 years were included. The primary outcome of the study was cognitive function, including overall cognition, global cognition, attention, executive function, memory, and visuospatial ability. The secondary outcome was motor function, consisting of overall motor function, balance, and gait. A subgroup analysis was also performed based on study characteristics to identify the potential factors for heterogeneity. Results: Eleven studies including 359 participants were included for final analysis. Primary analysis showed a significant moderate positive effect size (ES) of VR on overall cognition (g = 0.45; 95% confidence interval (CI) = 0.31-0.59; P < 0.001), attention/execution (g = 0.49; 95% CI = 0.26-0.72; P < 0.001), memory (g = 0.57; 95% CI = 0.29-0.85; P < 0.001), and global cognition (g = 0.32; 95% CI = 0.06-0.58; P = 0.02). Secondary analysis showed a significant small positive ES on overall motor function (g = 0.28; 95% CI = 0.05-0.51; P = 0.018). The ES on balance (g = 0.43; 95% CI = 0.06-0.80; P = 0.02) was significant and moderate. The ES on visuospatial ability and gait was not significant. In the subgroup analysis, heterogeneity was detected in type of immersion and population diagnosis. Conclusions: VR intervention is a beneficial non-pharmacological approach to improve cognitive and motor function in older adults with mild cognitive impairment or dementia, especially in attention/execution, memory, global cognition, and balance. VR intervention does not show superiority on visuospatial ability and gait performance.
Open-Loop Audio-Visual Stimulation (AVS): A Useful Tool for Management of Insomnia? [2018]Audio Visual Stimulation (AVS), a form of neurofeedback, is a non-pharmacological intervention that has been used for both performance enhancement and symptom management. We review the history of AVS, its two sub-types (close- and open-loop), and discuss its clinical implications. We also describe a promising new application of AVS to improve sleep, and potentially decrease pain. AVS research can be traced back to the late 1800s. AVS's efficacy has been demonstrated for both performance enhancement and symptom management. Although AVS is commonly used in clinical settings, there is limited literature evaluating clinical outcomes and mechanisms of action. One of the challenges to AVS research is the lack of standardized terms, which makes systematic review and literature consolidation difficult. Future studies using AVS as an intervention should; (1) use operational definitions that are consistent with the existing literature, such as AVS, Audio-visual Entrainment, or Light and Sound Stimulation, (2) provide a clear rationale for the chosen training frequency modality, (3) use a randomized controlled design, and (4) follow the Consolidated Standards of Reporting Trials and/or related guidelines when disseminating results.
The Feasibility of Using Virtual Reality and Eye Tracking in Research With Older Adults With and Without Alzheimer's Disease. [2021]Aim: To examine the feasibility of using large scale spatial, self-mobile, virtual reality, and eye tracking in older adults with and without Alzheimer's disease (AD). Methods: Older adults with early stage AD (n = 38) and a control group without AD (n = 50) were asked to find their way in a large, projected VR simulation of a retirement community repeatedly over 10 trials for each of 2 days, while wearing eye tracking glasses. Feasibility measures, including tolerance, side effects, and ability to complete the VR and eye tracking were collected. This study reports the analysis of the feasibility data for the VR and eye tracking and comparison of findings between the groups. Results: Over 80% of the subjects were able to complete the VR portion of the study. Only four subjects, all in the AD group, could not use the joystick and were excluded. Withdrawal rate (18%) was similar between the groups [X 2 (2) = 2.82, N = 88, p = 0.245] with most withdrawals occurring after the fourth trial. Simulation sickness was not significantly different between the groups. Only 60% of the subjects had completed eye tracking videos; more subjects in the AD group had complete eye tracking videos than the control group; X 2 (1) = 7.411, N = 88, p = 0.006. Eye tracking incompletion was primarily due to inability to calibration issues. Conclusion: Virtual reality testing and eye tracking can be used in older adults with and without AD in a large-scale way-finding task, but that there are some limitations.
Developing a virtual reality-based methodology for people with dementia: a feasibility study. [2019]The aim of this study was to examine the feasibility of virtual reality (VR) technology for use by persons with dementia (PWD). Data were obtained directly from six PWD regarding their experiences with a virtual environment (VE) of a large outdoor park. A user-centered method was developed to assess: (a) presence; (b) user inputs; (c) display quality; (d) simulation fidelity; and (e) overall system usability. The extent to which PWD could perform four functional activities in the VE was also investigated (e.g., mailing a letter). In addition, physical and psychological well-being of PWD while interacting with the VE was assessed objectively by recording heart rate during the VR sessions and subjectively with discrete questionnaire items and real-time prompts. Symptom profiles associated with simulator sickness were assessed with an adapted version of the Simulator Sickness Questionnaire. The study found that PWD to some extent experienced presence; perceived that objects were realistic and moved naturally; generally felt in control of the interaction; and demonstrated little difficulty using a joystick for navigation. The study also demonstrated that VR is an appropriate medium for assessing functional behavior within the context of an ecologically valid VE. PWD did not experience any significant increase in symptoms associated with simulator sickness, or detriments to their psychological and physical well-being. These findings demonstrated that it is feasible to work in VEs with PWD.
Video prompting versus other instruction strategies for persons with Alzheimer's disease. [2015]Two studies assessed the effectiveness of video prompting as a strategy to support persons with mild and moderate Alzheimer's disease in performing daily activities.
A randomised pilot study to assess the efficacy of an interactive, multimedia tool of cognitive stimulation in Alzheimer's disease. [2022]To determine the usefulness of an interactive multimedia internet-based system (IMIS) for the cognitive stimulation of Alzheimer's disease.