Virtual Reality + Cognitive Training for Mild Cognitive Impairment

Overseen By Miyeon Jung, PhD, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Advanced HF, Dementia, Schizophrenia, others

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

Compensation: Varies

Number of Visits: 16

Duration: 8 weeks

172 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new ways to help older adults with heart failure and mild cognitive impairment (trouble with memory and thinking). Researchers are testing two main approaches: a virtual reality experience with calming nature scenes and a computerized brain training program. Participants may try one of these, both, or continue with their usual care to determine the most effective method. The trial seeks participants who have heart failure and notice memory or thinking issues. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance care for heart failure and cognitive impairment.

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's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this virtual reality and computerized cognitive intervention is safe for older adults with mild cognitive impairment?

Research has shown that virtual reality (VR) cognitive training is generally safe. Some individuals have experienced mild to moderate VR sickness, such as dizziness or nausea, but these effects are usually not serious. Studies indicate that VR training can enhance attention and information processing speed in older adults with mild cognitive impairment (MCI).

For computerized cognitive training, research has demonstrated it to be a safe and effective method for boosting brain functions. Previous studies found no serious side effects, and it improved overall thinking skills and self-assessments in people with MCI.

When VR and computerized cognitive training are combined, no new safety issues have emerged beyond those already mentioned. This combined approach shows promise for improving brain health without adding significant risks.

In summary, these methods are generally well-tolerated, with only mild side effects reported, mainly related to VR use. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for mild cognitive impairment because they harness cutting-edge technology to potentially enhance cognitive function. Unlike standard care options, which often include medications like cholinesterase inhibitors or lifestyle changes, these treatments use a virtual reality approach and computerized cognitive training. The virtual reality intervention offers a unique experience where participants immerse themselves in calming nature scenes, which could stimulate brain areas involved in memory and attention. Meanwhile, the computerized training provides targeted exercises designed to boost specific cognitive skills. This innovative combination of sensory engagement and cognitive exercise could offer a more engaging and potentially effective way to address cognitive decline.

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

Research shows that virtual reality (VR) can greatly improve thinking skills and attention in people with mild memory problems. Studies have found that VR-based brain exercises enhance both quality of life and mental abilities. In this trial, participants may receive the VR-based cognitive restoration intervention, known as Vita. Similarly, computer-based brain training (CCT) has boosted memory, including remembering words and pictures, in older adults with mild memory issues. Participants in this trial may also receive the computerized cognitive training intervention, known as Com. A review of research highlights that CCT improves overall thinking skills and helps with daily activities. This trial will also explore the combination of VR and CCT, known as Vita+Com, which might further aid mental recovery by combining the fun aspects of VR with the focused exercises of CCT. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 55 with heart failure (Stage C) and mild cognitive issues, like memory or concentration problems. They must speak English and have someone to report on their daily activities. It's not for those with advanced heart failure, significant vision/hearing issues, major neurological/psychiatric conditions, life-threatening illnesses besides heart failure, or recent cognitive training.

Inclusion Criteria

I am 55 years old or older.

I have someone who can provide details about my daily activities.

I can make my own medical decisions or have someone who can.

Exclusion Criteria

I have not used computerized brain training or been in brain training studies this past year.

I do not have a major neurological disorder like dementia or Parkinson's.

You have a serious mental illness like schizophrenia or bipolar disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Vita, Com, or both interventions for cognitive restoration and training

8 weeks

Weekly check-in calls

Follow-up

Participants are monitored for changes in cognitive function, heart failure self-care, and quality of life

44 weeks

Assessments at 16 weeks and 1 year

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Reality and Computerized Cognitive Intervention

Trial Overview

The study tests a two-part treatment combining virtual reality-based cognitive restoration and computerized brain exercises to improve thinking skills and overall health in older adults with both heart failure and mild cognitive impairment.

How Is the Trial Designed?

Group I: Vita+Com (Both Vita and Com intervention) Experimental Treatment 1 Intervention

Participants randomized to Vita+Com will receive both Vita and Com simultaneously. They will spend 10 minutes on Vita and then 1 hour on Com per day, 2-3 days/week for 8 weeks (a total of 23.3 hours). Participants will receive weekly check-in calls from the intervention RA during the 8 weeks of intervention phase.

Group II: Vita (virtual reality-based cognitive restoration intervention) Experimental Treatment 1 Intervention

Participants randomized to Vita will receive a virtual reality head-mount device (e.g., Oculus Quest) to view nature pictures for 10 minutes (1 set of 10 pictures)/day, 2-3 days/week for 8 weeks (a total of 20 sets for 200 minutes, approximately 3.3 hours) based on the provided activity schedule. Participants will receive weekly check-in calls from the intervention RA during the 8 weeks of intervention phase.

Group III: Com (computerized cognitive training intervention ) Experimental Treatment 1 Intervention

Participants randomized to Com will receive a tablet computer (e.g., iPad) to complete BrainHQ training for 1 hour (6 exercises)/day, 2-3 days/week for 8 weeks (total of 20 hours) based on the provided activity schedule. Participants will receive weekly check-in calls from the intervention RA during the 8 weeks of intervention phase.

Group IV: Usual care Active Control 1 Intervention

Participants randomized to this control condition will continue to receive their usual care, but no interventions from the study team. We will monitor changes in their activities that may affect changes in cognitive function (e.g., starting book clubs) by weekly check-in calls during the 8 weeks of intervention phase.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

In a study involving 23 children, advanced virtual monochromatic reconstruction (Mono+) at 60 keV provided the best image quality for differentiating gray and white matter in dual-energy brain CT scans.

Mono+ outperformed conventional monochromatic reconstruction (Mono) and polychromatic scanning in terms of image quality, particularly in reducing artifacts in the posterior fossa.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advanced virtual monochromatic reconstruction of dual-energy unenhanced brain computed tomography in children: comparison of image quality against standard mono-energetic images and conventional polychromatic computed tomography. Park, J., Choi, YH., Cheon, JE., et al.[2018]

Computer-based cognitive interventions (CCIs) have shown significant benefits in improving specific cognitive domains such as memory and attention in individuals with mild cognitive impairment (MCI), based on a systematic review of 24 randomized controlled trials.

While CCIs did not demonstrate significant improvements in global cognition for individuals with dementia, one study indicated that CCIs could lead to memory improvements in those with subjective cognitive decline (SCD), suggesting that early intervention may be key for cognitive preservation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of computer-based interventions for community-dwelling people with cognitive decline: a systematic review with meta-analyses. Zuschnegg, J., Schoberer, D., Häussl, A., et al.[2023]

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]

Diagnostic dual energy CT (DECT) of the chest can be safely performed at submillisievert (sub-mSv) doses, achieving a mean effective dose of 0.7 mSv while maintaining good image quality in all 20 patients studied.

This study is the first to demonstrate that DECT can be conducted at such low radiation doses without losing relevant diagnostic information, indicating a significant advancement in imaging safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Submillisievert chest dual energy computed tomography: a pilot study. Canellas, R., Ackman, JB., Digumarthy, SR., et al.[2019]

Dual-layer dual-energy CT (DLDECT) effectively quantifies iodine and produces virtual noncontrast images across different phantom sizes and radiation doses, showing consistent performance regardless of the dose used (2-15 mGy).

In low-dose pediatric settings (0.9-1.8 mGy), while there is a slight decrease in accuracy and precision for iodine quantification, the overall performance remains largely dose-independent, indicating that patient size is a more critical factor than radiation dose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Patient Size and Radiation Dose on Accuracy and Precision of Iodine Quantification and Virtual Noncontrast Values in Dual-layer Detector CT-A Phantom Study. Van Hedent, S., Tatsuoka, C., Carr, S., et al.[2020]

A study involving 10 physiatrists, 6 occupational therapists, and 11 patients with mild cognitive impairment and mild dementia found that a fully immersive virtual reality (VR) cognitive training program was feasible and well-received, with high satisfaction scores from both therapists (5.75) and patients (5.64).

While the training did not show statistically significant improvements in response time or finger tapping, there was a noted decrease in response time after the session, suggesting a potential temporary increase in attention, and importantly, no participants experienced any adverse effects like motion sickness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Training Using Fully Immersive, Enriched Environment Virtual Reality for Patients With Mild Cognitive Impairment and Mild Dementia: Feasibility and Usability Study. Yun, SJ., Kang, MG., Yang, D., et al.[2020]

A study involving 61 older adults with mild cognitive impairment (MCI) found that a 12-week virtual reality (VR) rehabilitation program significantly improved various cognitive functions compared to conventional cognitive rehabilitation alone.

The VR group showed greater enhancements in orientation, visual-spatial perception, visuomotor organization, thinking operation, and attention/concentration, suggesting that integrating VR into cognitive rehabilitation can be beneficial for older adults with MCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of a Virtual Reality-Based Intervention on Cognitive Functions in Older Adults with Mild Cognitive Impairment: A Single-Blind, Randomized Controlled Trial. Torpil, B., Şahin, S., Pekçetin, S., et al.[2021]

A 50% reduction in iodinated contrast medium (CM) during brain CT angiography is possible while maintaining or even improving image quality using virtual monoenergetic images (VMI) at 50 keV, based on a study involving consecutive patients without intracranial stenosis/occlusion.

VMI can enhance the quality of CT angiography images, making it a useful tool for salvaging examinations that may have been considered non-diagnostic due to poor CM timing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Image quality of spectral brain computed tomography angiography using halved dose of iodine contrast medium. Fransson, V., Mellander, H., Ramgren, B., et al.[2023]

In a study of 57 patients undergoing dual-energy computed tomography angiography (DE-CTA), optimized window settings for virtual monoenergetic images (VMI) significantly improved image quality compared to standard settings.

The noise-optimized VMI at 40-keV (M40+) provided the highest subjective image quality scores, indicating that tailored post-processing can enhance vascular contrast in DE-CTA imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Carotid and cerebrovascular dual-energy computed tomography angiography: Optimization of window settings for virtual monoenergetic imaging reconstruction. D'Angelo, T., Lenga, L., Arendt, CT., et al.[2021]

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 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]

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