VR and Adaptive Technology for Mild Cognitive Impairment

Recruiting at 2 trial locations

Overseen By Xin Lin, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Blindness, Deafness, Terminal illness, others

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

Compensation: Varies

Number of Visits: 1

1202 Participants Needed

Trial Summary

What is the purpose of this trial?

Project 1: The goal of this research project is to examine usability and acceptance of virtual reality (VR) applications and their efficacy with older adults. This highly innovative cross-site Stage 1 Intervention Development Project (NIH (National Institutes of Health) Stage Model) will apply the CREATE systematic approach to the design and evaluation of an immersive VR program, Cognitive Activity Social Technology (CAST), for older adults. The program will provide a suite of virtual cognitive, social and activity engagement applications; and allow for virtual interactions. Project 2: The goal of this Stage 1 (NIH Stage Model) Intervention Development cross-site project is to develop, using a user-centered design approach, and evaluate an innovative intelligent adaptive software package aimed at providing cognitive and social support and engagement to older adults with mild cognitive impairment (MCI). The system will be designed to adapt to the needs and abilities of the user. The investigator's goal is to develop a unique and highly innovative technology tool that can provide adaptive support to aging individuals with MCI, even as cognition might deteriorate further. Speech data collected as part of an embedded reminiscence feature will advance fundamental knowledge of how speech and language production data might serve as an early indicator of cognitive decline. Project 3: The goal for this project is to support the cognitive components of older adults' health-management activities through development of digital assistant technology tools tailored to three exemplar healthcare management task activities: accessing support services, managing healthcare finances, and using the health-management tools provided by Medicare.gov. This project will leverage the machine-intelligence expertise of the research investigators collaborators and the research investigators experience in developing and evaluating technologies for supporting the health and wellbeing needs of older adults to harness technology to provide cognitive support to aging adults, including those with Mild Cognitive Impairment (MCI) and lower SES. The project will be comprised of three phases.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment VR and Adaptive Technology for Mild Cognitive Impairment?

Research suggests that virtual reality (VR) can be as effective as traditional cognitive rehabilitation therapy for improving cognitive functions in older adults with mild cognitive impairment. Although the studies are limited and have small sample sizes, VR offers unique advantages like immersive and interactive experiences that may enhance engagement and outcomes. ^{1 2 3 4 5}

Is the VR and Adaptive Technology treatment safe for humans?

Research shows that using virtual reality (VR) for cognitive training in people with mild cognitive impairment is generally safe. In studies, participants experienced no major adverse events, with only minor issues like dizziness and fatigue reported by a small number of users. ^{2 3 5 6 7}

How is the VR and Adaptive Technology treatment for Mild Cognitive Impairment different from other treatments?

This treatment is unique because it uses virtual reality (VR) and adaptive technology to engage patients in social, physical, and cognitive activities, offering an immersive and interactive experience that traditional therapies do not provide. It aims to improve cognitive function and daily living skills through innovative digital interventions, which are not typically part of standard treatments for mild cognitive impairment. ^{1 2 3 8 9}

Research Team

Sara J Czaja, PhD

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

This trial is for older adults, aged 60 and above, who have been clinically diagnosed with mild cognitive impairment (MCI). Participants should be able to read English at a 6th-grade level or higher, have correctable vision of at least 20/60, and score between 18-26 on the MoCA test. It's not suitable for those outside this age range or cognitive ability.

Inclusion Criteria

I am over 60, can read English well, have decent vision with glasses if needed, and my cognitive test score is 23 or lower.

I am 65 or older, can read English at a 6th grade level, and have at least 20/60 vision with glasses or contacts.

I am 62 or older, can read English, have decent vision, mild memory issues without major daily activity impairments, not severely depressed, and no dementia.

Exclusion Criteria

I am visually or hearing impaired, have a terminal illness, or severe motor impairment.

Project 2: Cognitive impairment (MoCA ≤ 25)

I have chronic neck pain or an injury that could make wearing a headset uncomfortable.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Usability Testing and Development

Usability testing across the three CREATE sites with older adults, and heuristic analysis to gather information on user preferences, usability problems, implementation, and training protocols.

2-3 hours per session

1 session (in-person)

Pilot Randomized Trial

Participants will be randomized to the VR CAST condition or a tablet control condition, using the VR program/tablet in their home for two months.

2 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Project 1, Phase 2: VR Program for Social, Activity, and Cognitive Engagement
• Project 2, Phase 2: Intelligent Adaptive System
• Project 3, Phase 3: Intelligent Decision Support Tool

Trial Overview CREATE V includes three projects: A VR program (CAST) for mental and social stimulation; an intelligent adaptive system that adjusts to users' cognitive levels; and a digital assistant tool designed to help manage healthcare tasks. These interventions aim to support cognition in aging individuals with MCI.

Participant Groups

Group I: Project 3 - Phase 3: DATA Condition Experimental Treatment 1 Intervention

Participants in the DATA condition, instead of access to a generic digital assistant, will have DATA at their disposal to solve the queries and will be encouraged to use it as the primary resource. Qualitative data on how they use this tool, in isolation and in conjunction with other sources of information, will be collected. Following completion of the problems, as in Phase 2, measures of DATA usability will be collected including usefulness and comprehension associated with each tool, perceived mental workload, and usability with an efficient, two-item test based on the widely used System Usability Scale: UMUX-LITE). The investigators will then conduct an audio-recorded semi-structured exit interview about various perceptions participants had regarding the challenges associated with successfully solving the health-management problems.

Group II: Project 2 - Phase 2: Active Intervention Group Experimental Treatment 1 Intervention

Participants will receive a tablet with the adaptive program and be provided with internet service following the baseline assessment. Participants will receive a 3-day training in their home that will include basic tablet/internet training and training on the features of the system. The training will also encompass a module on internet etiquette and security against potential spam and fraud. Participants will be provided with practice tasks in between sessions. Participants will be provided with a "hands-on" performance assessment at the end of the second session and concepts/procedures that are problematic will be reviewed.

Group III: Project 1 - Phase 2: VR Program Experimental Treatment 1 Intervention

Training will occur over 3 days and be conducted by research investigators in the participants' homes. Training will include training on the proper placement of the headset, the viewing lens, system headphones, and safety guidelines. The research investigator will aid in the set-up of the VR system in the home, which will be pre-loaded with applications, and will recommend an area to use the system to ensure a safe play area free of obstacles. Participants will be provided with practice tasks between training sessions. Participants will be provided with a "hands-on" performance assessment at the beginning of the second session and concepts/procedures that are problematic will be reviewed. Participants will be contacted one-week post training to determine if they are having any problems by study investigators. Following training, participants will use the CAST VR program and tablet at will, though encouraged to use it at least three times per week for 20 minutes.

Group IV: Project 2 - Phase 2: Waitlist Control Active Control 1 Intervention

Participants will receive a 3-day training in their home. Participants will also receive a tablet, internet support for 12 months and training. This will include instructions for accessing content pertaining to the research study.

Group V: Project 3 - Phase 2: Development of Digital Assistant Tools Active Control 1 Intervention

The study includes one session that will last approximately 2 - 3 hours. The study involves interactions with digital assistants developed by the research team, the participants will answer structured interview questions regarding their experiences using the system. The researchers will assess the participants' comments along dimensions such as type of information requested, preference for format of information, points of confusion, and likes and dislikes of features, which will form the basis for a prioritized list of features/functions to be modified for the next prototype iteration.

Group VI: Project 1 - Phase 1: Development/Refinement of VR program; Usability Testing/Development of Training Active Control 1 Intervention

The study includes one session that will last approximately 2 - 3 hours. The study involves completing some questionnaires that gather background demographic information and a structured needs assessment interview to gather information on user preferences, usability problems, implementation and training protocols.

Group VII: Project 3 - Phase 3: Usual-Tool Control Condition Active Control 1 Intervention

Participants will have access to a generic, non-adapted voice assistant available on a provided tablet. The experimenter will use a standard script that allows for guidance to participants in searching for information relevant to the problems. Participants will indicate when they are ready to move on to the next problem, which will be followed by their assessment of the confidence they have in having solved the problem, their comprehension of the information associated with the problem, their assessment of the usefulness of the available information, and the perceived mental workload they experienced in solving the problem. Investigators will track, code, and analyze participants' online interactions with any websites they use. For each of the three task activity domains, overall performance scores will be computed, as will performance scores for the simpler and more complex problems.

Group VIII: Project 3 - Phase 1: Problem Space Specification and Task Selection Active Control 1 Intervention

Both the subject matter experts and older adult participants will participate in individual structured interviews for each activity category, 1.5 - 2 hours in length. This qualitative data will provide rich contextualized information regarding the specific needs of older adults for access to services, financial health management, and Medicare.gov services utilization. This data will be used to identify current barriers and facilitators to successful healthcare management that could be targeted by technology solutions and/obtain details of the challenges that are common in each activity category.

Group IX: Project 1 - Phase 2: Tablet Control Condition Active Control 1 Intervention

Training will occur over 3 days and be conducted by research investigators in the participants' homes. Participants in the control condition will receive a tablet, internet support for 2 months and training (including training on cybersecurity). This will include instructions for accessing content similar to, but in 2-D, so less immersive than that included in the VR program (e.g., virtual museum tours, One click, etc.). Participants will complete all assessments and will be provided with an Android tablet that has a 10.1" display, built in modem, and a front facing camera. Research investigators are providing people with tablets for standardization. Research Assessor (RA) Training, Certification and Treatment Fidelity. At follow-up assessments, assessors and data analysts will be blinded to treatment condition.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Findings from Research

A systematic review of three studies involving 130 older adults with Mild Cognitive Impairment (MCI) suggests that Virtual Reality-based cognitive rehabilitation therapy (VR-CRT) is at least as effective as traditional cognitive rehabilitation therapy (CRT) in improving cognitive function and executive function.

Despite the promising results, the limited number of studies and small sample sizes raise concerns about the reliability of the findings, highlighting the need for more rigorous research and standardized VR protocols to better assess the efficacy of VR-CRT in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality and cognitive rehabilitation for older adults with mild cognitive impairment: A systematic review. Tortora, C., Di Crosta, A., La Malva, P., et al.[2023]

Virtual reality (VR) tools can significantly enhance cognitive rehabilitation for individuals with mild cognitive impairment (MCI) and early-stage Alzheimer's disease, addressing the growing need for effective support services for the elderly population.

The immersive and interactive nature of VR technology offers unique advantages in improving daily life activities for those affected by cognitive impairments, suggesting a promising avenue for healthcare and caregiver assistance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using virtual reality for cognitive training of the elderly. García-Betances, RI., Jiménez-Mixco, V., Arredondo, MT., et al.[2022]

Home-based virtual reality (VR) exercise is safe and feasible for individuals with mild cognitive impairment, with participants completing 99% of the prescribed sessions over 6 weeks without major adverse events.

While most participants enjoyed the VR program and reported physical benefits, no significant changes were observed in physical or cognitive outcomes after the 6-week intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Home-Based Nonimmersive Virtual Reality to Encourage Physical and Cognitive Exercise in People With Mild Cognitive Impairment: A Feasibility Study. Sheehy, L., Sveistrup, H., Knoefel, F., et al.[2022]

The culture-based virtual reality (VR) training program was found to be feasible and well-tolerated by patients with amnestic mild cognitive impairment (aMCI), with a high adherence rate of 91.55%.

Despite the program's feasibility, it did not lead to significant improvements in cognitive function as measured by various tests, including the Korean Mini-Mental State Examination and working memory assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Tolerability of a Culture-Based Virtual Reality (VR) Training Program in Patients with Mild Cognitive Impairment: A Randomized Controlled Pilot Study. Park, JH., Liao, Y., Kim, DR., et al.[2020]

The virtual reality examination (VR-E) developed for assessing cognitive function showed promising results, correlating well with established tests like the MMSE and MoCA-J in a study of 77 participants aged around 75 years.

VR-E effectively distinguished between different levels of cognitive impairment, with a completion time of about 5 minutes, making it a less burdensome option for detecting mild cognitive changes, although some participants faced challenges due to understanding or health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A cognitive function test utilizing eye tracking technology in virtual reality]. Mizukami, K., Taguchi, M., Kouketsu, T., et al.[2023]

The study developed a digital neurorehabilitation platform called NeuroVRehab.PT, designed specifically for patients with mild cognitive impairment (MCI), using realistic virtual environments based on a supermarket setting.

Feedback from health professionals indicated that NeuroVRehab.PT is clinically applicable and ecologically valid, suggesting it could effectively support MCI patients in improving their instrumental activities of daily living (IADL).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photo-Realistic Interactive Virtual Environments for Neurorehabilitation in Mild Cognitive Impairment (NeuroVRehab.PT): A Participatory Design and Proof-of-Concept Study. Ferreira-Brito, F., Alves, S., Santos, O., et al.[2020]

A meta-analysis of 13 randomized controlled trials found that virtual reality (VR)-based neuropsychological interventions significantly improve cognitive functioning in patients with mild cognitive impairment (MCI), particularly enhancing executive function with a large effect size (g = 0.60).

Longer VR interventions (15 hours or more) also showed moderate to large effects on working memory, language, and visuoconstruction, indicating that the duration of the intervention plays a crucial role in its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of virtual reality-based neuropsychological interventions in improving cognitive functioning in patients with mild cognitive impairment: A systematic review and meta-analysis. Gómez-Cáceres, B., Cano-López, I., Aliño, M., et al.[2023]

References

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

Virtual reality and cognitive rehabilitation for older adults with mild cognitive impairment: A systematic review. [2023]

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

Using virtual reality for cognitive training of the elderly. [2022]

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

The Use of Home-Based Nonimmersive Virtual Reality to Encourage Physical and Cognitive Exercise in People With Mild Cognitive Impairment: A Feasibility Study. [2022]

4. Greece pubmed.ncbi.nlm.nih.gov

Our experience with informative and communication technologies (ICT) in dementia. [2019]

5. Canada pubmed.ncbi.nlm.nih.gov

Mixed Reality Prototype of Multimodal Screening for Early Detection of Cognitive Impairments in Older Adults: Protocol Development and Usability Study. [2022]

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

Feasibility and Tolerability of a Culture-Based Virtual Reality (VR) Training Program in Patients with Mild Cognitive Impairment: A Randomized Controlled Pilot Study. [2020]

7. Japan pubmed.ncbi.nlm.nih.gov

[A cognitive function test utilizing eye tracking technology in virtual reality]. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Photo-Realistic Interactive Virtual Environments for Neurorehabilitation in Mild Cognitive Impairment (NeuroVRehab.PT): A Participatory Design and Proof-of-Concept Study. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Effectiveness of virtual reality-based neuropsychological interventions in improving cognitive functioning in patients with mild cognitive impairment: A systematic review and meta-analysis. [2023]