Brain Health Virtual Reality Study

Study Overview
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Brief Summary
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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.

Official Title
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Interventions to Promote Brain Health Virtual Reality Study

Conditions
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Memory Disorder, Spatial, Memory Disorders, Aging, Aging Problems, Memory Loss, Memory Impairment, Memory Disorders in Old Age, Mild Cognitive Impairment, Cognitive Decline, Cognitive Change, Cognition Disorders in Old Age

Intervention / Treatment
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* Behavioral: Physical Activity
* Behavioral: Cognitive Activity (VR)
* Behavioral: Physical and Cognitive Activity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 50-85 years of age Fluent in English Can safely ride a stationary bike Exclusion Criteria: Dementia History of a neurological disorder Severe sensory deficits Inability to perform intervention (e.g., inability to cycle safely) Contraindications to MRI scan (e.g., pacemaker) Fear of needles/ blood Prior history of fainting due to sight of needles of blood

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: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cognitive activity - VR spatial navigation only<br>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. | Behavioral: Cognitive Activity (VR)<br>* There will be three sessions a week over the course of 16 weeks.<br>|
| Active Comparator: Physical activity - Cycling only<br>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. | Behavioral: Physical Activity<br>* There will be three sessions a week over the course of 16 weeks.<br>|
| Experimental: Combined, simultaneous physical and cognitive activity<br>The combined physical and cognitive activity VR program will consist of a spatial navigation program that increases difficulty and length per trial over time. | Behavioral: Physical and Cognitive Activity<br>* There will be three sessions a week over the course of 16 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hippocampal MRI | The hippocampus has been shown to be a selectively vulnerable region in AD, and several studies, including our own, identified a dysfunctional brain signal in the hippocampus in MCI patients. We propose to examine the effects of exercise on remediating this hyperactive signal exhibited in MCI patients. | 16 Weeks | 
| MST memory performance | 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. The MST is a memory task designed to heavily tax memory processes for making fine discriminations between highly similar objects or unrelated objects. | 16 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual Reality, technology, intervention, exercise, cycling, memory, brain health, aging