Healthy AgingNRVRNCT04678778
Virtual Reality Study - COVID-19 Protocol
A study testing Physical and Cognitive Activity in people with Healthy Aging, run by University of Southern California at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging
- What is being tested?
- Physical and Cognitive Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2019to 19 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mark and Mary Stevens Neuroimaging and Informatics Institute of the University of Southern California
Los Angeles, California, 90033
About this study
Official title: 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.
- Conditions
- Healthy Aging
- Being tested
- Physical and Cognitive Activity
- Keywords
- Virtual Reality, VR, Cognitive Activity, Physical Activity, Bike, Cycling, Intervention, USC, Brain Health
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical and Cognitive ActivityBehavioural
There are three sessions a week for the course of 12 weeks. Each session consists of 5 trials.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Physical and Cognitive Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start19 Mar 2019
- Primary completion19 Feb 2021
- Study completion19 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Judy Pa, University of Southern California
- Investigators
- Judy Pa, PhD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04678778
- Sponsor's protocol ID
- HS17-00354
- Acronym
- NRVR
- Status last verified
- Apr 2021
- First submitted
- 11 Dec 2020
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Physical and Cognitive Activity in a VR Environment - COVID-19 Protocol
- ClinicalTrials.gov ID
- NCT04678778
- Acronym / sponsor ID
- NRVR / HS17-00354
- Conditions
- Healthy Aging
- Keywords
- Virtual Reality, VR, Cognitive Activity, Physical Activity, Bike, Cycling, Intervention, USC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 19 Mar 2019 (actual)
- Primary completion
- 19 Feb 2021 (actual)
- Study completion
- 19 Feb 2021 (actual)
- First posted
- 22 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combined, simultaneous physical and cognitive activity | Experimental | Behavioral: Physical and Cognitive ActivityThe 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. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical and Cognitive ActivityThere are three sessions a week for the course of 12 weeks. Each session consists of 5 trials. | Behavioural | Combined, simultaneous physical and cognitive activity |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judy Pa, PhD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical and Cognitive Activity in people with Healthy Aging, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Magnetic Resonance Image (MRI) brain scan of hippocampal volume (cubic mm) (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2021.