Brain Health Virtual Reality Study

Sponsor

University of California, San Diego (Other)

Overall Status

Recruiting

CT.gov ID

NCT06124339

Collaborator

(none)

150

Enrollment

Location

Arms

65.8

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The Interventions for Brain Health Virtual Reality Study is a NIH-funded clinical research trial at the University of California San Diego (UCSD) Health under the supervision of the study principal investigator Dr. Judy Pa. The overarching goal of this trial is to use a novel virtual reality (VR) based intervention that simultaneously engages physical and cognitive activity aimed at improving brain health and cognition in older adults. The investigators will compare 3 types of interventions: physical activity, VR cognitive activity, and combined VR physical and cognitive activity over 16 weeks to evaluate physical and brain health changes.

Condition or Disease	Intervention/Treatment	Phase
Aging Aging Problems Memory Loss Memory Impairment Memory Disorders in Old Age Memory Disorder, Spatial Memory Disorders Mild Cognitive Impairment Cognitive Decline Cognitive Change Cognition Disorders in Old Age	Behavioral: Physical Activity Behavioral: Cognitive Activity (VR) Behavioral: Physical and Cognitive Activity	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Interventions to Promote Brain Health Virtual Reality Study

Actual Study Start Date :

Aug 8, 2023

Anticipated Primary Completion Date :

Aug 8, 2028

Anticipated Study Completion Date :

Feb 1, 2029

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Cognitive activity - VR spatial navigation only VR spatial navigation program will consist of a spatial navigation program that increases difficulty and length per trial over time. Spatial navigation is the ability to navigate between multiple elements/landmarks widely used in computer games. A trial is a test of performance or quality of someone or something.	Behavioral: Cognitive Activity (VR) There will be three sessions a week over the course of 16 weeks.
Active Comparator: Physical activity - Cycling only The physical activity program will consist of a stationary bike cycling program. Each day will consist of a cycling program of varying levels of difficulty for 20-50 minutes.	Behavioral: Physical Activity There will be three sessions a week over the course of 16 weeks.
Experimental: Combined, simultaneous physical and cognitive activity The combined physical and cognitive activity VR program will consist of a spatial navigation program that increases difficulty and length per trial over time.	Behavioral: Physical and Cognitive Activity There will be three sessions a week over the course of 16 weeks.

Arm

Intervention/Treatment

Active Comparator: Cognitive activity - VR spatial navigation only

VR spatial navigation program will consist of a spatial navigation program that increases difficulty and length per trial over time. Spatial navigation is the ability to navigate between multiple elements/landmarks widely used in computer games. A trial is a test of performance or quality of someone or something.

Behavioral: Cognitive Activity (VR)

There will be three sessions a week over the course of 16 weeks.

Active Comparator: Physical activity - Cycling only

The physical activity program will consist of a stationary bike cycling program. Each day will consist of a cycling program of varying levels of difficulty for 20-50 minutes.

Behavioral: Physical Activity

There will be three sessions a week over the course of 16 weeks.

Experimental: Combined, simultaneous physical and cognitive activity

The combined physical and cognitive activity VR program will consist of a spatial navigation program that increases difficulty and length per trial over time.

Behavioral: Physical and Cognitive Activity

There will be three sessions a week over the course of 16 weeks.

Outcome Measures

Primary Outcome Measures

Hippocampal MRI [16 Weeks]
The hippocampus has been shown to be a selectively vulnerable region in AD, and several studies, including our own, identified a dysfunctional brain signal in the hippocampus in MCI patients. We propose to examine the effects of exercise on remediating this hyperactive signal exhibited in MCI patients.
MST memory performance [16 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. The MST is a memory task designed to heavily tax memory processes for making fine discriminations between highly similar objects or unrelated objects.