Virtual Reality Study - COVID-19 Protocol

NCT ID: NCT04678778

Last Updated: 2021-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-19

Study Completion Date

2021-02-19

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.

Detailed Description

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Conditions

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Healthy Aging

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Physical and Cognitive Activity

Intervention Type BEHAVIORAL

There are three sessions a week for the course of 12 weeks. Each session consists of 5 trials.

Interventions

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Physical and Cognitive Activity

There are three sessions a week for the course of 12 weeks. Each session consists of 5 trials.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Southern California

OTHER

Sponsor Role lead

Responsible Party

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Judy Pa

Associate Professor of Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Judy Pa, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

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Mark and Mary Stevens Neuroimaging and Informatics Institute of the University of Southern California

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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HS17-00354

Identifier Type: -

Identifier Source: org_study_id

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