Virtual Reality Study - COVID-19 Protocol

Study Overview
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Brief Summary
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The overarching goal of this pilot clinical trial is to use a novel virtual reality (VR)-based intervention that simultaneously engages physical and cognitive activity aimed at improving brain and cognitive outcomes in older adults. Physical activity is a promising lifestyle intervention for mitigating cognitive decline or delaying onset of dementia. However, to fully leverage beneficial brain effects of physical activity, training the brain to learn and engage in a cognitively stimulating environment may be the key to enhanced brain and cognitive outcomes.

Official Title
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Targeted Physical and Cognitive Activity in a VR Environment - COVID-19 Protocol

Conditions
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Healthy Aging

Intervention / Treatment
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* Behavioral: Physical and Cognitive Activity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 50-85 Years Old Able to Walk Without Assistance Fluent in English No Ferromagnetic Metal in Body Able to Participate in Moderate Aerobic Physical Activity Exclusion Criteria: Severe Brain Injury/ Head Trauma Pacemakers or Metal Implants Claustrophobia Contradictions to Magnetic Resonance Imaging (MRI)/ Positron Emission Tomography (PET) Brain Scans Opposition to Blood Draws

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combined, simultaneous physical and cognitive activity<br>The combined physical and cognitive activity VR arm will participate in our customized spatial navigation program that increases difficulty and length per trial over time. As described in the Game Design section, each session will consist of 5 trials. The first trial will be a long-delay free recall condition from the previous day's path. The next 4 trials will consist of learning, cued recall, and free recall. This VR-based spatial navigation program has been tested in our feasibility trial for safety and tolerability in older adults. | Behavioral: Physical and Cognitive Activity<br>* There are three sessions a week for the course of 12 weeks. Each session consists of 5 trials.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Magnetic Resonance Image (MRI) brain scan of hippocampal volume (cubic mm) | The hippocampus has been shown to be a selectively vulnerable region in Alzheimer's Disease (AD), and several studies, including our own, identified a dysfunctional brain signal in the hippocampus in Mild Cognitive Impairment (MCI) patients. We propose to examine the effects of exercise on remediating this hyperactive signal exhibited in MCI patients. | 12 weeks | 
| Mnemonic Similarity Task for visual memory performance - discrimination index | With the study's primary focus on hippocampal function, we will use the Mnemonic Separation Task (MST), a hippocampus-dependent discrimination test of similar objects, as our primary cognitive outcome. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual Reality, VR, Cognitive Activity, Physical Activity, Bike, Cycling, Intervention, USC, Brain Health