NCT04678778

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 19, 2019

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

December 11, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 22, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 19, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 19, 2021

Completed
Last Updated

April 29, 2021

Status Verified

April 1, 2021

Enrollment Period

1.9 years

First QC Date

December 11, 2020

Last Update Submit

April 27, 2021

Conditions

Healthy Aging

Keywords

Virtual RealityVRCognitive ActivityPhysical ActivityBikeCyclingInterventionUSCBrain Health

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

Combined, simultaneous physical and cognitive activity

EXPERIMENTAL

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

Interventions

Physical and Cognitive ActivityBEHAVIORAL

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

Combined, simultaneous physical and cognitive activity

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Years Old
  • Able to Walk Without Assistance
  • Fluent in English
  • No Ferromagnetic Metal in Body
  • Able to Participate in Moderate Aerobic Physical Activity

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Officials

  • Judy Pa, PhD

    University of Southern California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Neurology

Study Record Dates

First Submitted

December 11, 2020

First Posted

December 22, 2020

Study Start

March 19, 2019

Primary Completion

February 19, 2021

Study Completion

February 19, 2021

Last Updated

April 29, 2021

Record last verified: 2021-04

Locations

US(1)