Virtual Reality Study - COVID-19 Protocol

Not Applicable

Completed

• Conditions: Healthy Aging
• Interventions: Behavioral: Physical and Cognitive Activity

• Registration Number: NCT04678778
• Lead Sponsor: University of Southern California

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-19
• Study First Submitted: 2020-12-11
• Study First Submitted QC: 2020-12-21
• Study First Posted: 2020-12-22
• Primary Completion: 2021-02-19
• Study Completion: 2021-02-19
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-27
• Last Update Posted: 2021-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Combined, simultaneous physical and cognitive activity	Physical and Cognitive Activity	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.

Primary Outcome Measures

Name	Time	Method
Mnemonic Similarity Task for visual memory performance - discrimination index	12 weeks	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.
Magnetic Resonance Image (MRI) brain scan of hippocampal volume (cubic mm)	12 weeks	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.

Trial Locations

Locations (1)

Mark and Mary Stevens Neuroimaging and Informatics Institute of the University of Southern California; 🇺🇸 Los Angeles, California, United States