Brain Health Virtual Reality Study

NCT ID: NCT06124339

Last Updated: 2024-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-08

Study Completion Date

2029-02-01

Brief Summary

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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.

Detailed Description

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Conditions

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Cognitive Activity (VR)

Intervention Type BEHAVIORAL

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

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.

Group Type ACTIVE_COMPARATOR

Physical Activity

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

Physical and Cognitive Activity

Intervention Type BEHAVIORAL

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

Interventions

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Physical Activity

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

Intervention Type BEHAVIORAL

Cognitive Activity (VR)

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

Intervention Type BEHAVIORAL

Physical and Cognitive Activity

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Judy Pa

Co-Director of ADCS

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of California, San Diego

San Diego, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Study Coordinator

Role: CONTACT

6195432113

Isenberg

Role: CONTACT

6195433494

Facility Contacts

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Study coordinator

Role: primary

619-543-2113

Other Identifiers

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803273

Identifier Type: -

Identifier Source: org_study_id

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