Brain Health Virtual Reality Study

Interventions to Promote Brain Health Virtual Reality Study

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.

Study Overview

• Status: Recruiting
• Conditions: Cognitive Change; Aging; Mild Cognitive Impairment; Cognitive Decline; Memory Disorders; Memory Impairment; Cognition Disorders in Old Age; Aging Problems; Memory Loss; Memory Disorders in Old Age; Memory Disorder, Spatial
• Intervention / Treatment: Behavioral: Cognitive Activity (VR); Behavioral: Physical Activity; Behavioral: Physical and Cognitive Activity

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Study Coordinator; Phone Number: 6195432113; Email: Brainhealth@health.ucsd.edu
• Study Contact Backup: Name: Isenberg; Phone Number: 6195433494; Email: aisenberg@health.ucsd.edu

Study Locations

• United States
  • California
    • San Diego, California, United States, 92122
      • Recruiting
      • University of California, San Diego
      • Contact: Study coordinator; Phone Number: 619-543-2113; Email: brainhealth@health.ucsd.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. 50-85 years of age
2. Fluent in English
3. Can safely ride a stationary bike

Exclusion Criteria:

1. Dementia
2. History of a neurological disorder
3. Severe sensory deficits
4. Inability to perform intervention (e.g., inability to cycle safely)
5. Contraindications to MRI scan (e.g., pacemaker)
6. Fear of needles/ blood
7. Prior history of fainting due to sight of needles of blood

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MST memory performance	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.	16 Weeks

Collaborators and Investigators

• Sponsor: University of California, San Diego

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2023
• Primary Completion (Estimated): August 8, 2028
• Study Completion (Estimated): February 1, 2029

Study Registration Dates

• First Submitted: November 3, 2023
• First Submitted That Met QC Criteria: November 3, 2023
• First Posted (Actual): November 9, 2023

Study Record Updates

• Last Update Posted (Actual): July 10, 2024
• Last Update Submitted That Met QC Criteria: July 8, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: memory; exercise; aging; Virtual Reality; intervention; technology; cycling; brain health
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Cognitive Dysfunction; Cognition Disorders; Memory Disorders
• Other Study ID Numbers: 803273

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No