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Clinical Trials/NCT06124339
NCT06124339Active, not recruitingNot Applicable

Interventions to Promote Brain Health Virtual Reality Study

University of California, San Diego1 site in 1 country150 target enrollmentStarted: August 8, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
150
Locations
1
Primary Endpoint
MST memory performance

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
50 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 50-85 years of age
  • Fluent in English
  • Can safely ride a stationary bike

Exclusion Criteria

  • 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

Arms & Interventions

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.

Intervention: Cognitive Activity (VR) (Behavioral)

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.

Intervention: Physical and Cognitive Activity (Behavioral)

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.

Intervention: Physical Activity (Behavioral)

Outcomes

Primary Outcomes

MST memory performance

Time Frame: 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Judy Pa

Co-Director of ADCS

University of California, San Diego

Study Sites (1)

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