Virtual Reality Study - COVID-19 Protocol (NRVR)

April 27, 2021 updated by: Judy Pa, University of Southern California

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • Mark and Mary Stevens Neuroimaging and Informatics Institute of the University of Southern California

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Combined, simultaneous 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.
Behavioral: Physical and Cognitive Activity
There are three sessions a week for the course of 12 weeks. Each session consists of 5 trials.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Magnetic Resonance Image (MRI) brain scan of hippocampal volume (cubic mm)
Time Frame: 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.
12 weeks
Mnemonic Similarity Task for visual memory performance - discrimination index
Time Frame: 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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Investigators

  • Principal Investigator: Judy Pa, PhD, University of Southern California

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 19, 2019

Primary Completion (Actual)

February 19, 2021

Study Completion (Actual)

February 19, 2021

Study Registration Dates

First Submitted

December 11, 2020

First Submitted That Met QC Criteria

December 21, 2020

First Posted (Actual)

December 22, 2020

Study Record Updates

Last Update Posted (Actual)

April 29, 2021

Last Update Submitted That Met QC Criteria

April 27, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HS17-00354

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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