Virtual Reality for Cognitive Impairment

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of California, San Diego

Disqualifiers: Dementia, Neurological disorder, Sensory deficits, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The Interventions for Brain Health Virtual Reality Study is a NIH-funded clinical research trial at the University of California San Diego (UCSD) Health under the supervision of the study principal investigator Dr. Judy Pa. The overarching goal of this trial is to use a novel virtual reality (VR) based intervention that simultaneously engages physical and cognitive activity aimed at improving brain health and cognition in older adults. The investigators will compare 3 types of interventions: physical activity, VR cognitive activity, and combined VR physical and cognitive activity over 16 weeks to evaluate physical and brain health changes.

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 data supports the effectiveness of the treatment Virtual Reality for Cognitive Impairment?

Research shows that virtual reality (VR) can be a helpful tool for cognitive rehabilitation, especially for people with brain injuries, by improving memory and other cognitive functions. Additionally, combining VR with physical and cognitive exercises may help delay or prevent the progression of mild cognitive impairment to dementia. ^{1 2 3 4 5}

Is virtual reality exercise safe for people with mild cognitive impairment?

A study found that home-based virtual reality exercise is safe for people with mild cognitive impairment, as there were no major adverse events reported during the 6-week program. ^{1 3 6 7 8}

How does virtual reality treatment for cognitive impairment differ from other treatments?

Virtual reality treatment for cognitive impairment is unique because it combines physical and cognitive exercises in an engaging, interactive environment, which can be done at home. This approach is different from traditional therapies as it uses technology to simulate real-life activities, potentially making it more enjoyable and accessible for patients. ^{3 4 5 7 9}

Research Team

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

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

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.

Participant Groups

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+

Dr. Christopher Longhurst

University of California, San Diego

Chief Medical Officer since 2021

MD and MS in Medical Informatics from UC Davis

Patty Maysent

University of California, San Diego

Chief Executive Officer since 2016

MBA from Stanford University

Findings from Research

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]

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]

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]

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]

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]

References

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

Improving cognitive function after brain injury: the use of exercise and virtual reality. [2022]

2. Japan pubmed.ncbi.nlm.nih.gov

Virtual reality for cognitive rehabilitation after brain injury: a systematic review. [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. England pubmed.ncbi.nlm.nih.gov

Effects of virtual reality cognitive training in individuals with mild cognitive impairment: A systematic review and meta-analysis. [2021]

5. England 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. [2023]

6. Japan pubmed.ncbi.nlm.nih.gov

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

7. England pubmed.ncbi.nlm.nih.gov

Examining the effect of virtual reality therapy on cognition post-stroke: a systematic review and meta-analysis. [2022]

8. United States 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. [2019]

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

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