Virtual Reality for Cognitive Impairment

Overseen By Isenberg

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Diego

Disqualifiers: Dementia, Neurological disorder, Sensory deficits, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if combining virtual reality (VR) with physical activity can boost brain health in older adults. Researchers will divide participants into three groups: one will engage in physical activities like cycling, another will participate in VR-based cognitive games, and the third will combine both activities. The trial lasts 16 weeks and examines the impact of these activities on brain and physical health. Suitable candidates include English speakers aged 50 to 85 who can safely ride a stationary bike. As an unphased trial, this study provides participants with a unique opportunity to contribute to innovative research that could enhance brain health strategies for older adults.

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

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

What prior data suggests that this virtual reality intervention is safe for cognitive impairment?

Research shows that older adults generally handle virtual reality (VR) cognitive training well. Studies have examined its usability and found that only a few people report mild dizziness or nausea, known as VR sickness. Importantly, VR is a promising tool to boost motivation and improve thinking and memory skills.

For activities that combine physical and mental exercises using VR, evidence shows these can enhance thinking skills in older adults with memory problems. The data suggest that participants usually experience improvements without major negative effects, indicating the treatment is safe and typically harmless.

Overall, previous studies have shown that the treatments tested in this trial are safe and beneficial, with few negative effects reported. Participants generally manage these activities well, making them a promising option for improving brain health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using virtual reality (VR) for cognitive impairment because it offers an innovative way to enhance both physical and mental activities simultaneously. Unlike traditional methods like medication or standard physical exercises, this approach combines physical cycling with a VR spatial navigation game, potentially boosting brain function more effectively. The VR aspect uniquely engages users by simulating real-world navigation tasks, which may help improve memory and cognitive skills in a more immersive and interactive way. This dual activity could lead to better overall cognitive improvements compared to traditional single-focus treatments.

What evidence suggests that this trial's treatments could be effective for cognitive impairment?

Research has shown that virtual reality (VR) activities can enhance memory and thinking skills in older adults, particularly those with memory problems. Studies have found that fully immersive VR training can boost overall brain function in individuals with mild memory issues. In this trial, participants may engage in various activities.

One group will participate in VR activities that combine physical exercise and mental challenges, which have strong evidence of significantly improving thinking skills. These combined activities have improved attention, mental abilities, and quality of life for those with memory difficulties.

Another group will focus on physical activities, like cycling, known to support brain health by increasing blood flow and stimulating brain activity, helping to maintain or improve thinking skills.

A third group will engage in cognitive activities using VR spatial navigation only. Overall, combining physical and mental challenges through VR appears promising for improving brain health in older adults. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for English-speaking adults aged 50-85 who can safely ride a stationary bike. It's not suitable for those with dementia, severe sensory deficits, neurological disorders, or an inability to cycle safely. People with MRI contraindications like pacemakers or a fear of needles/blood are also excluded.

Inclusion Criteria

I am between 50 and 85 years old.

Can ride a stationary bike without any safety concerns.

Fluent in English

Exclusion Criteria

You have major problems with your sense of touch, taste, or smell.

I have a history of a neurological disorder.

I cannot safely perform the required physical activities.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in one of three interventions: physical activity, VR cognitive activity, or combined VR physical and cognitive activity to improve brain health and cognition

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Activity (VR)
• Physical Activity
• Physical and Cognitive Activity

Trial Overview

The study tests three interventions over 16 weeks: physical activity alone, VR cognitive activity alone, and a combination of both VR physical and cognitive activities. The goal is to see which intervention best improves brain health and cognition in older adults.

How Is the Trial Designed?

Group I: Combined, simultaneous physical and cognitive activity Experimental Treatment 1 Intervention

The combined physical and cognitive activity VR program will consist of a spatial navigation program that increases difficulty and length per trial over time.

Group II: Physical activity - Cycling only Active Control 1 Intervention

The physical activity program will consist of a stationary bike cycling program. Each day will consist of a cycling program of varying levels of difficulty for 20-50 minutes.

Group III: Cognitive activity - VR spatial navigation only Active Control 1 Intervention

VR spatial navigation program will consist of a spatial navigation program that increases difficulty and length per trial over time. Spatial navigation is the ability to navigate between multiple elements/landmarks widely used in computer games. A trial is a test of performance or quality of someone or something.

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Published Research Related to This Trial

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]

A systematic review of 17 randomized controlled trials involving 744 participants found that virtual reality (VR) cognitive training significantly improved global cognitive function and executive function in individuals with mild cognitive impairment (MCI).

The improvements in cognitive function were moderate in effect size, but the training did not show significant benefits for delayed memory, immediate memory, attention, or daily living activities, indicating that while VR can help with certain cognitive aspects, its effects may be limited and short-term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of virtual reality cognitive training in individuals with mild cognitive impairment: A systematic review and meta-analysis. Zhong, D., Chen, L., Feng, Y., et al.[2021]

A 4-week program of nonimmersive virtual reality (VR) exercise significantly improved cognitive functions, such as attention and memory, in 13 adults with traumatic brain injury (TBI) compared to control groups.

A single session of VR exercise also led to notable improvements in reaction and movement times, suggesting that even short bouts of exercise in a virtual environment can enhance cognitive performance in TBI patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving cognitive function after brain injury: the use of exercise and virtual reality. Grealy, MA., Johnson, DA., Rushton, SK.[2022]

In a clinical trial with 44 older adults with mild cognitive impairment (MCI), participating in Xbox 360 Kinect cognitive games led to significant improvements in EEG wave patterns and cognitive functions after both a single session and a 6-week intervention.

After 6 weeks, participants showed notable enhancements in cognitive assessments (MMSE and MoCA scores) and performance on cognitive tasks (TMT-A and TMT-B), indicating that these games could be an effective therapeutic option for improving cognition in MCI patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Xbox 360 Kinect Cognitive Games Improve Slowness, Complexity of EEG, and Cognitive Functions in Subjects with Mild Cognitive Impairment: A Randomized Control Trial. Amjad, I., Toor, H., Niazi, IK., et al.[2019]

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]

A systematic review of eight studies with 196 participants found that exercise-based virtual reality (VR) therapy did not show significant improvements in cognitive function compared to control interventions for individuals post-stroke.

Despite the lack of cognitive benefits, VR therapy was noted for its potential to enhance patient satisfaction and provide adaptable rehabilitation experiences, suggesting it may still be valuable in stroke recovery settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining the effect of virtual reality therapy on cognition post-stroke: a systematic review and meta-analysis. Wiley, E., Khattab, S., Tang, A.[2022]

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 combined cognitive and physical interventions significantly improved global cognitive abilities in older adults with mild cognitive impairment, as shown by a meta-analysis of 7 randomized controlled trials involving 8 articles.

However, the same interventions did not show significant effects on memory or executive function/attention, indicating that while VR can enhance overall cognition, its impact on specific cognitive domains may vary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of virtual reality combined cognitive and physical interventions on cognitive function in older adults with mild cognitive impairment: A systematic review and meta-analysis. Yan, M., Zhao, Y., Meng, Q., et al.[2023]

Virtual reality (VR) programs have shown positive effects in cognitive evaluations and interventions for patients with brain injuries, particularly in improving memory impairments.

VR is a promising and cost-effective tool for cognitive rehabilitation after brain injury, as indicated by a review of 17 selected studies from a pool of 350 articles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality for cognitive rehabilitation after brain injury: a systematic review. Shin, H., Kim, K.[2022]

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