Brain Health Virtual Reality Study

NCT06124339 | Recruiting

• 1 other identifier: 803273
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Virtual Reality; technology; intervention; exercise; cycling; memory; brain health; aging

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Cognitive activity - VR spatial navigation only

ACTIVE COMPARATOR

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)

Physical activity - Cycling only

ACTIVE COMPARATOR

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

Combined, simultaneous physical and cognitive activity

EXPERIMENTAL

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

Interventions

Physical Activity BEHAVIORAL

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

Physical activity - Cycling only

Cognitive Activity (VR) BEHAVIORAL

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

Cognitive activity - VR spatial navigation only

Physical and Cognitive Activity BEHAVIORAL

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

Combined, simultaneous physical and cognitive activity

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• Fluent in English
• Can safely ride a stationary bike

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California, San Diego

San Diego, California, 92122, United States

RECRUITING

MeSH Terms

Conditions

Memory Disorders; Cognitive Dysfunction; Motor Activity

Interventions

Exercise; Restraint, Physical

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Central Study Contacts

Study Coordinator

CONTACT

6195432113; Brainhealth@health.ucsd.edu

Isenberg

CONTACT

6195433494; aisenberg@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Director of ADCS

Study Record Dates

• First Submitted: November 3, 2023
• First Posted: November 9, 2023
• Study Start: August 8, 2023
• Primary Completion (Estimated): August 8, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: July 10, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)